SARS-CoV-2 Variant Classifications and Definitions

Updated Aug. 24, 2021

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Key Points

• Genetic variants of SARS-CoV-2 have been emerging and circulating around the world throughout the COVID-19 pandemic.

• Viral mutations and variants in the United States are routinely monitored through sequence-based surveillance, laboratory studies, and epidemiological investigations.

• A US government SARS-CoV-2 Interagency Group (SIG) developed a Variant Classification scheme that defines three classes of SARS-CoV-2 variants:

  • Variant of Interest

  • Variant of Concern

  • Variant of High Consequence

• The Alpha (B.1.1.7), Beta (B.1.351, B.1.351.2, B.1.351.3), Delta (B.1.617.2, AY.1, AY.2, AY.3), and Gamma (P.1, P.1.1, P.1.2) variants circulating in the United States are classified as variants of concern.

• To date, no variants of high consequence have been identified in the United States.

• Laboratory studies suggest specific monoclonal antibody treatments may be less effective for treating cases of COVID-19 caused by variants with certain substitutions or combinations of substitutions in the spike protein.

  • L452R is present in Iota (B.1.526), B.1.427, B.1.429, Kappa (B.1.617.1), B.1.617.3, and the lineages and sub-lineages designated Delta (B.1.617.2, AY.1, AY.2, AY.3).

  • E484K is present in Eta (B.1.525), Gamma (P.1), and Beta (B.1.351), but only some strains of Iota (B.1.526) and Alpha (B.1.1.7).

  • The combination of K417N, E484K, and N501Y substitutions is present in Beta (B.1.351).

  • The combination of K417T, E484K, and N501Y substitutions is present in Gamma (P.1).

• B.1.427 and B.1.429 have been removed from the Variants of Interest list due to declining prevalence and very few detections in recent months. Vaccines authorized for use in the United States are effective against these variants and effective therapeutics are available. CDC continues to monitor all variants circulating within the United States.

Delta Variant

The Delta variant causes more infections and spreads faster than earlier forms of the virus that causes COVID-19. It might cause more severe illness than previous strains in unvaccinated people.

• Vaccines continue to reduce a person’s risk of contracting the virus that cause COVID-19, including this variant.

• Vaccines continue to be highly effective at preventing hospitalization and death, including against this variant.

• Fully vaccinated people with breakthrough infections from this variant appear to be infectious for a shorter period.

• Get vaccinated and wear masks indoors in public spaces to reduce the spread of this variant.

About the Delta VariantVariants in the US

Viruses constantly change through mutation. A variant has one or more mutations that differentiate it from other variants in circulation. As expected, multiple variants of SARS-CoV-2 have been documented in the United States and globally throughout this pandemic. To inform local outbreak investigations and understand national trends, scientists compare genetic differences between viruses to identify variants and how they are related to each other.

Variant classifications

The US Department of Health and Human Services (HHS) established a SARS-CoV-2 Interagency Group (SIG) to improve coordination among the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Food and Drug Administration (FDA), Biomedical Advanced Research and Development Authority (BARDA), and Department of Defense (DoD). This interagency group is focused on the rapid characterization of emerging variants and actively monitors their potential impact on critical SARS-CoV-2 countermeasures, including vaccines, therapeutics, and diagnostics.

• Variant of Interest (VOI)– View current VOI in the United States that are being monitored and characterized by federal agencies

• Variant of Concern (VOC)– View current VOC in the United States that are being closely monitored and characterized by federal agencies

• Variant of High Consequence (VOHC) – Currently there are no SARS-CoV-2 variants that rise to the level of high consequence

Notes: Each classification of variant includes the possible attributes of lower classes (e.g., VOC includes the possible attributes of VOI); variant status might escalate or deescalate based on emerging scientific evidence. This page will be updated as needed to show the variants that belong to each class. The World Health Organizationexternal icon (WHO) also classifies variant viruses as Variants of Concern and Variants of Interest; US classifications may differ from those of WHO because the importance of variants may differ by location. To assist with public discussions of variants, WHO proposed using labels consisting of the Greek Alphabet, e.g., Alpha, Beta, Gamma, as a practical way to discuss variants by non-scientific audiences. The labels assigned to each variant are provided in the tables below.

See Variant Proportions in the U.S.

Variant of Interest

A variant with specific genetic markers that have been associated with changes to receptor binding, reduced neutralization by antibodies generated against previous infection or vaccination, reduced efficacy of treatments, potential diagnostic impact, or predicted increase in transmissibility or disease severity.

Possible attributes of a variant of interest:

• Specific genetic markers that are predicted to affect transmission, diagnostics, therapeutics, or immune escape.

• Evidence that it is the cause of an increased proportion of cases or unique outbreak clusters.

• Limited prevalence or expansion in the US or in other countries.

A variant of interest might require one or more appropriate public health actions, including enhanced sequence surveillance, enhanced laboratory characterization, or epidemiological investigations to assess how easily the virus spreads to others, the severity of disease, the efficacy of therapeutics and whether currently authorized vaccines offer protection.

Current variants of interest in the United States that are being monitored and characterized are listed below. This will be updated when a new variant of interest is identified.

Selected Characteristics of SARS-CoV-2 Variants of Interest

WHO Label: Eta

Pango Lineage: B.1.525 (Pango lineageexternal icon)a

Spike Protein Substitutions: A67V, 69del, 70del, 144del, E484K, D614G, Q677H, F888L

Name (Nextstrainexternal icon)b: 20A/S:484K

First Identified: United Kingdom and Nigeria – December 2020

Attributes:

• Potential reduction in neutralization by some Emergency Use Authorization (EUA) monoclonal antibody treatments 7, 14

• Potential reduction in neutralization by convalescent and post-vaccination sera22

WHO Label: Iota

Pango Lineage: B.1.526 (Pango lineageexternal icon)a

Spike Protein Substitutions: L5F, (D80G*), T95I, (Y144-*), (F157S*), D253G, (L452R*), (S477N*), E484K, D614G, A701V, (T859N*), (D950H*), (Q957R*)

Name (Nextstrainexternal icon)b: 20C/S:484K

First Identified: United States (New York) – November 2020

BEI Reference Isolatec: NR-55359external icon

Attributes:

• Reduced susceptibility to the combination of bamlanivimab and etesevimab monoclonal antibody treatment; however, the clinical implications of this are not known.7 Alternative monoclonal antibody treatments are available.14

• Reduced neutralization by convalescent and post-vaccination sera22, 24

WHO Label: Kappa

Pango Lineage: B.1.617.1 (Pango lineageexternal icon)a

Spike Protein Substitutions: (T95I), G142D, E154K, L452R, E484Q, D614G, P681R, Q1071H

Name (Nextstrainexternal icon)b: 20A/S:154K

First Identified: India – December 2020

Attributes:

• Potential reduction in neutralization by some EUA monoclonal antibody treatments7, 14

• Potential reduction in neutralization by post-vaccination sera26

WHO Label: None

Pango Lineage: B.1.617.3 (Pango lineageexternal icon)a

Spike Protein Substitutions: T19R, G142D, L452R, E484Q, D614G, P681R, D950N

Name (Nextstrainexternal icon)b: 20A

First Identified: India – October 2020

Attributes:

• Potential reduction in neutralization by some EUA monoclonal antibody treatments7, 14

• Potential reduction in neutralization by post-vaccination sera26

Footnotes for Variants of Interest

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Variant of Concern

A variant for which there is evidence of an increase in transmissibility, more severe disease (e.g., increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.

Possible attributes of a variant of concern:

In addition to the possible attributes of a variant of interest

• Evidence of impact on diagnostics, treatments, or vaccines

  • Widespread interference with diagnostic test targets

  • Evidence of substantially decreased susceptibility to one or more class of therapies

  • Evidence of significant decreased neutralization by antibodies generated during previous infection or vaccination

  • Evidence of reduced vaccine-induced protection from severe disease

• Evidence of increased transmissibility

• Evidence of increased disease severity

Variants of concern might require one or more appropriate public health actions, such as notification to WHO under the International Health Regulations, reporting to CDC, local or regional efforts to control spread, increased testing, or research to determine the effectiveness of vaccines and treatments against the variant. Based on the characteristics of the variant, additional considerations may include the development of new diagnostics or the modification of vaccines or treatments.

Current variants of concern in the United States that are being closely monitored and characterized are listed below. This table will be updated when a new variant of concern is identified.

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Selected Characteristics of SARS-CoV-2 Variants of Concern

WHO Label: Alpha

Pango Lineage: B.1.1.7 (Pango lineageexternal icon)a

Spike Protein Substitutions: 69del, 70del, 144del, (E484K*), (S494P*), N501Y, A570D, D614G, P681H, T716I, S982A, D1118H (K1191N*)

Name (Nextstrainexternal icon)b: 20I/501Y.V1

First Identified: United Kingdom

BEI Reference Isolatec: NR-54000external icon

Attributes:

• ~50% increased transmission5

• Potential increased severity based on hospitalizations and case fatality rates6

• No impact on susceptibility to EUA monoclonal antibody treatments7,14

• Minimal impact on neutralization by convalescent and post-vaccination sera8-13,19

WHO Label: Beta

Pango Lineage(s): B.1.351, B.1.351.2, B.1.351.3 (Pango lineageexternal icon)a

Spike Protein Substitutions: D80A, D215G, 241del, 242del, 243del, K417N, E484K, N501Y, D614G, A701V

Name (Nextstrainexternal icon)b: 20H/501.V2

First Identified: South Africa

BEI Reference Isolatec: NR-55282external icon

Attributes:

• ~50% increased transmission16

• Significantly reduced susceptibility to the combination of bamlanivimab and etesevimab monoclonal antibody treatment,7 but other EUA monoclonal antibody treatments are available 14

• Reduced neutralization by convalescent and post-vaccination sera8,12,18,19,20

WHO Label: Delta

Pango Lineage: B.1.617.2, AY.1, AY.2, AY.3, AY.4, AY.5, AY.6, AY.7, AY.8, AY.9, AY.10, AY.11, AY.12 (Pango lineageexternal icon)a

Spike Protein Substitutions: T19R, (V70F*), T95I, G142D, E156-, F157-, R158G, (A222V*), (W258L*), (K417N*), L452R, T478K, D614G, P681R, D950N

Name (Nextstrainexternal icon)b: 21A/S:478K

First Identified: India

Attributes:

• Increased transmissibility 29

• Potential reduction in neutralization by some EUA monoclonal antibody treatments 7, 14

• Potential reduction in neutralization by post-vaccination sera 21

WHO Label: Gamma

Pango Lineage(s): P.1, P.1.1, P.1.2 (Pango lineageexternal icon)a

Spike Protein Substitutions: L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, D614G, H655Y, T1027I

Name (Nextstrainexternal icon)b: 20J/501Y.V3

First Identified: Japan/Brazil

BEI Reference Isolatec: NR-54982external icon

Attributes:

• Significantly reduced susceptibility to the combination of bamlanivimab and etesevimab monoclonal antibody treatment,7 but other EUA monoclonal antibody treatments are available 14

• Reduced neutralization by convalescent and post-vaccination sera15

Footnotes for Variants of Concern

Variant of High Consequence

A variant of high consequence has clear evidence that prevention measures or medical countermeasures (MCMs) have significantly reduced effectiveness relative to previously circulating variants.

Possible attributes of a variant of high consequence:

In addition to the possible attributes of a variant of concern

• Impact on Medical Countermeasures (MCM)

  • Demonstrated failure of diagnostic test targets

  • Evidence to suggest a significant reduction in vaccine effectiveness, a disproportionately high number of vaccine breakthrough cases, or very low vaccine-induced protection against severe disease

  • Significantly reduced susceptibility to multiple Emergency Use Authorization (EUA) or approved therapeutics

  • More severe clinical disease and increased hospitalizations

A variant of high consequence would require notification to WHO under the International Health Regulations, reporting to CDC, an announcement of strategies to prevent or contain transmission, and recommendations to update treatments and vaccines.

Currently, there are no SARS-CoV-2 variants that rise to the level of high consequence.

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Treatment considerations for healthcare providers

Substitutions of Concern for SARS-CoV-2 Monoclonal Antibody Therapies

In the United States, there are three anti-SARS-CoV-2 monoclonal antibody treatments with FDA Emergency Use Authorization (EUA) for the treatment of COVID-19: bamlanivimab plus etesevimabexternal icon, casirivimab plus imdevimab,external icon, and sotrovimabexternal icon.

CDC’s national genomic surveillance program identifies new and emerging SARS-CoV-2 variants to determine implications for COVID-19 diagnostics, treatments, or vaccines authorized for use in the United States. Sequences with similar genetic changes are grouped into lineages, and multiple lineages can have the same substitutions. For example, the E484K substitution is found in lineages B.1.351, P.1, B.1.526, and many others. Genomic surveillance efforts provide the capability to detect viruses that have reduced susceptibility to treatments more quickly.

In laboratory studies, SARS-CoV-2 variants that contain certain substitutions in the spike protein cause a marked reduction in susceptibility to bamlanivimab and may have reduced sensitivity to etesevimab and casirivimab. The L452R substitution found in the B.1.427 and B.1.429 lineages has been shown to cause a significant reduction in susceptibility to bamlanivimab and a modest decrease in susceptibility to the combination of bamlanivimab and etesevimab, although the clinical implications of this modest decrease are not known. 7 The E484K substitution found in the B.1.351, P.1, and B.1.526 lineages also results in a marked reduction in susceptibility to bamlanivimab, as well as the combination of bamlanivimab and etesevimab.7 Laboratory studies also suggest that the K417N and K417T substitutions, which are present in the B.1.351 and P.1 variants, respectively, along with the E484K mutation, reduces virus susceptibility to casirivimab, although the combination of casirivimab and imdevimab appears to retain activity.14 There is no reported reduction in susceptibility of variants to sotrovimab.28

The data below shows the national and regional unweighted proportions of SARS-CoV-2 that contain the L452R or E484K substitution, individually, as well as the unweighted proportions of SARS-CoV-2 that contain the combination of K417N, E484K, and N501Y substitutions or the combination of K417T, E484K, and N501Y substitutions. As new data become available, additional substitutions may be added below. The national and regional proportions provided below will be updated weekly.

Resources

Monoclonal Antibody COVID-19 Infusionexternal icon

Statement on Anti-SARS-CoV-2 Monoclonal Antibodies EUA | COVID-19 Treatment Guidelines (nih.gov)external icon

Unweighted Proportions of SARS-CoV-2 Substitutions of Therapeutic Concern

L452R Spike Protein Substitution

National Proportiona: 94.8%

Regional Proportionsb

Region 1

95.6%

Region 2

96.0%

Region 3

96.1%

Region 4

94.3%

Region 5

95.1%

Region 6

94.5%

Region 7

97.3%

Region 8

95.7%

Region 9

95.2%

Region 10

93.0%

Common Pango Lineages with Spike Protein Substitutionsc

B.1.617.2 (Delta)

AY.4 (Delta)

AY.3 (Delta)

AY.12 (Delta)

AY.2 (Delta)

E484K Spike Protein Substitution

National Proportiona: 2.0%

Regional Proportionsb

Region 1

2.6%

Region 2

1.7%

Region 3

1.7%

Region 4

2.1%

Region 5

2.3%

Region 6

1.1%

Region 7

0.7%

Region 8

1.4%

Region 9

2.1%

Region 10

2.6%

Common Pango Lineages with Spike Protein Substitutionsc

P.1 (Gamma)

B.1.621

B.1.621.1

B.1.526 (Iota)

B.1.1.7 (Alpha)

K417N, E484K, N501Y Spike Protein Substitution

National Proportiona: 0.1%

Regional Proportionsb

Region 1

0.2%

Region 2

0.1%

Region 3

0.0%

Region 4

0.1%

Region 5

0.0%

Region 6

0.1%

Region 7

0.0%

Region 8

0.1%

Region 9

0.2%

Region 10

0.7%

Common Pango Lineages with Spike Protein Substitutionsc

B.1.621

B.1.351 (Beta)

B.1.351.3 (Beta)

K417T, E484K, N501Y Spike Protein Substitution

National Proportiona: 0.8%

Regional Proportionsb

Region 1

1.1%

Region 2

0.5%

Region 3

0.6%

Region 4

1.0%

Region 5

0.6%

Region 6

0.6%

Region 7

0.4%

Region 8

0.3%

Region 9

0.8%

Region 10

1.0%

Common Pango Lineages with Spike Protein Substitutionsc

P.1 (Gamma)

P.1.2 (Gamma)

P.1.7 (Gamma)

Footnotes for Unweighted Proportions of SARS-CoV-2 Substitutions of Therapeutic Concern

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References

References for SARS-CoV-2 Variant Classifications and Definitions

Related Resources

• Emerging SARS-CoV-2 Variants

• New Variants of the Virus that Causes COVID-19

• Cases, Data, and Surveillance

• COVID-19 Genomic Epidemiology Toolkit

Hospital-acquired COVID-19 tends to be picked up from other patients, not from healthcare workers

Date:August 24, 2021Source:University of CambridgeSummary:The majority of patients who contracted COVID-19 while in hospital did so from other patients rather than from healthcare workers, concludes a new study.Share:

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The majority of patients who contracted COVID-19 while in hospital did so from other patients rather than from healthcare workers, concludes a new study from researchers at the University of Cambridge and Addenbrooke's Hospital.

The study provides previously unprecedented detail on how infections might spread in a hospital context, showing that a minority of individuals can cause most of the transmission.

The researchers analysed data from the first wave of the pandemic, between March and June 2020. While a great deal of effort is made to prevent the spread of viruses within hospital by keeping infected and non-infected individuals apart, this task is made more difficult during times when the number of infections is high. The high level of transmissibility of the virus and the potential for infected individuals to be asymptomatic both make this task particularly challenging.

Looking back at data from the first wave, researchers identified five wards at Addenbrooke's Hospital, part of Cambridge University Hospitals (CUH) NHS Foundation Trust, where multiple individuals, including patients and healthcare workers, tested positive for COVID-19 within a short space of time, suggesting that a local outbreak might have occurred.

Using new statistical methods that combine viral genome sequence data with clinical information about the locations of individuals, the researchers identified cases where the data were consistent with transmission occurring between individuals in the hospital. Looking in detail at these transmission events highlighted patterns in the data.

The results of the study, published today in eLife, showed that patients who were infected in the hospital were mostly infected by other patients, rather than by hospital staff. Out of 22 cases where patients were infected in hospital, 20 of these were the result of the virus spreading from patients to other patients

Dr Chris Illingworth, a lead author on the study, who carried out his research while at Cambridge's MRC Biostatistics Unit, said: "The fact that the vast majority of infections were between patients suggests that measures taken by hospital staff to prevent staff transmitting the virus to patients, such as the wearing of masks, were likely to have been effective.

"But it also highlights why it is important that patients themselves are screened for COVID-19 regularly, even if asymptomatic, and wear face masks where possible."

The study found contrasting results among healthcare workers, who were almost as likely to be infected by patients as they were by other healthcare workers. This was one piece of evidence that motivated the decision to upgrade the respiratory protection worn by healthcare workers in COVID-19 wards at CUH. A recent Cambridge study indicated that this resulted in staff being better protected against catching COVID-19.

The researchers also found a trend towards individuals either infecting no one else, or infecting multiple other people -- just over a fifth of patients (21%) caused 80% of the infections. This phenomenon is sometimes called 'superspreading' and can make infection control very challenging. Whether or not an individual can be identified in advance as being more or less likely to pass on the virus is an ongoing topic of research.

Dr William Hamilton, an infectious diseases clinician at CUH and co-lead author on the study said: "Preventing new cases of hospital-based infection is a critical part of our work. Here we have shown that analysing clinical and viral genome sequence data can produce insights that inform infection control measures, which are so important for protecting patients and healthcare workers alike."

The research was funded by COG-UK, Wellcome, the Academy of Medical Sciences, the Health Foundation and the NIHR Cambridge Biomedical Research Centre.

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Story Source:

Materials provided by University of Cambridge. The original text of this story is licensed under a Creative Commons License. Note: Content may be edited for style and length.

Journal Reference:

• Christopher JR Illingworth, William L Hamilton, Ben Warne, Matthew Routledge, Ashley Popay, Chris Jackson, Tom Fieldman, Luke W Meredith, Charlotte J Houldcroft, Myra Hosmillo, Aminu S Jahun, Laura G Caller, Sarah L Caddy, Anna Yakovleva, Grant Hall, Fahad A Khokhar, Theresa Feltwell, Malte L Pinckert, Iliana Georgana, Yasmin Chaudhry, Martin D Curran, Surendra Parmar, Dominic Sparkes, Lucy Rivett, Nick K Jones, Sushmita Sridhar, Sally Forrest, Tom Dymond, Kayleigh Grainger, Chris Workman, Mark Ferris, Effrossyni Gkrania-Klotsas, Nicholas M Brown, Michael P Weekes, Stephen Baker, Sharon J Peacock, Ian G Goodfellow, Theodore Gouliouris, Daniela de Angelis, M Estée Török. Superspreaders drive the largest outbreaks of hospital onset COVID-19 infections. eLife, 2021; 10 DOI: 10.7554/eLife.67308

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University of Cambridge. "Hospital-acquired COVID-19 tends to be picked up from other patients, not from healthcare workers." ScienceDaily. ScienceDaily, 24 August 2021. <www.sciencedaily.com/releases/2021/08/210824083504.htm>.

Combination of mask wearing and keeping windows open is best for reducing COVID-19 risk in cars, new study finds

Date:August 24, 2021Source:University of SurreySummary:New research has confirmed that keeping car windows open to draw in fresh air is key to reducing the risk of contracting the virus in vehicle environments -- but there are trade-offs.Share:

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As the country prepares to live in a post-Covid-19 world and car travel -- including taxi and car-sharing services that mix households -- returns to normal, new research from the University of Surrey has confirmed that keeping car windows open to draw in fresh air is key to reducing the risk of contracting the virus in vehicle environments -- but there are trade-offs.

In a paper published by Environment International, Surrey's renowned Global Centre for Clean Air Research (GCARE) explored what motorists must consider to make sure their in-car environments are as Covid-secure as possible.

The GCARE team used sensors to monitor pollution particles concentration, map how those particles varied during different settings in the vehicle and evaluate exposure dose per km of PM2.5 for three different ventilation settings (open window, air conditioning using fresh air, and air conditioning using air recirculation). The team also used sensors to monitor CO2 emission -- a proxy used in the experiment for Covid-19.

The GCARE researchers found that maintaining a continuous intake of fresh air by keeping the windows open -- while also wearing a mask -- is the best way to guard against the transmission of Covid-19 -- but this increases occupants' exposure to toxic air pollution particles.

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Motorists face a dilemma, since guarding against air pollution by keeping windows closed in turn aggravates the risk from Covid-19: the study found that the probability of Covid-19 transmission rate increased by 28.5 per cent when windows are closed and air recirculation is switched on.

For the best chance of remaining safer from both Covid-19 and external air pollution, the GCARE team found that keeping the windows closed -- which mitigates air pollution particles -- while running air conditioning on ambient mode (drawing in fresh air from outside) to minimise exposure to Covid-19, is the optimal balance.

Professor Prashant Kumar, lead author of the study, Associate Dean (International) and Founding Director of GCARE at the University of Surrey, said:

"It's vital that the scientific community provides society with the data it needs so we can learn from the painful experience of the past two years.

"Our research found that if your priority is to reduce the risk of contracting Covid-19, wearing a mask and keeping car windows open is the ideal approach."

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Story Source:

Materials provided by University of Surrey. Note: Content may be edited for style and length.

Journal Reference:

• Prashant Kumar, Hamid Omidvarborna, Arvind Tiwari, Lidia Morawska. The nexus between in-car aerosol concentrations, ventilation and the risk of respiratory infection. Environment International, 2021; 157: 106814 DOI: 10.1016/j.envint.2021.106814

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University of Surrey. "Combination of mask wearing and keeping windows open is best for reducing COVID-19 risk in cars, new study finds." ScienceDaily. ScienceDaily, 24 August 2021. <www.sciencedaily.com/releases/2021/08/210824135342.htm>.

FDA Approves First COVID-19 Vaccine

Approval Signifies Key Achievement for Public Health

August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Related Information

• Comirnaty Prescribing Information

• Cormirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA

###

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Using artificial intelligence for early detection and treatment of illnesses

Date:August 20, 2021Source:Technische Universität DresdenSummary:Artificial intelligence (AI) will fundamentally change medicine and healthcare: Diagnostic patient data, e.g. from ECG, EEG or X-ray images, can be analyzed with the help of machine learning, so that diseases can be detected at a very early stage based on subtle changes. However, implanting AI within the human body is still a major technical challenge. Scientists have now succeeded in developing a bio-compatible implantable AI platform that classifies in real time healthy and pathological patterns in biological signals such as heartbeats. It detects pathological changes even without medical supervision.Share:

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Artificial intelligence (AI) will fundamentally change medicine and healthcare: Diagnostic patient data, e.g. from ECG, EEG or X-ray images, can be analyzed with the help of machine learning, so that diseases can be detected at a very early stage based on subtle changes. However, implanting AI within the human body is still a major technical challenge. TU Dresden scientists at the Chair of Optoelectronics have now succeeded for the first time in developing a bio-compatible implantable AI platform that classifies in real time healthy and pathological patterns in biological signals such as heartbeats. It detects pathological changes even without medical supervision. The research results have now been published in the journal Science Advances.

In this work, the research team led by Prof. Karl Leo, Dr. Hans Kleemann and Matteo Cucchi demonstrates an approach for real-time classification of healthy and diseased bio-signals based on a biocompatible AI chip. They used polymer-based fiber networks that structurally resemble the human brain and enable the neuromorphic AI principle of reservoir computing. The random arrangement of polymer fibers forms a so-called "recurrent network," which allows it to process data, analogous to the human brain. The nonlinearity of these networks enables to amplify even the smallest signal changes, which -- in the case of the heartbeat, for example -- are often difficult for doctors to evaluate. However, the nonlinear transformation using the polymer network makes this possible without any problems.

In trials, the AI was able to differentiate between healthy heartbeats from three common arrhythmias with an 88% accuracy rate. In the process, the polymer network consumed less energy than a pacemaker. The potential applications for implantable AI systems are manifold: For example, they could be used to monitor cardiac arrhythmias or complications after surgery and report them to both doctors and patients via smartphone, allowing for swift medical assistance.

"The vision of combining modern electronics with biology has come a long way in recent years with the development of so-called organic mixed conductors," explains Matteo Cucchi, PhD student and first author of the paper. "So far, however, successes have been limited to simple electronic components such as individual synapses or sensors. Solving complex tasks has not been possible so far. In our research, we have now taken a crucial step toward realizing this vision. By harnessing the power of neuromorphic computing, such as reservoir computing used here, we have succeeded in not only solving complex classification tasks in real time but we will also potentially be able to do this within the human body. This approach will make it possible to develop further intelligent systems in the future that can help save human lives."

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Journal Reference:

• Matteo Cucchi, Christopher Gruener, Lautaro Petrauskas, Peter Steiner, Hsin Tseng, Axel Fischer, Bogdan Penkovsky, Christian Matthus, Peter Birkholz, Hans Kleemann, Karl Leo. Reservoir computing with biocompatible organic electrochemical networks for brain-inspired biosignal classification. Science Advances, 2021; 7 (34): eabh0693 DOI: 10.1126/sciadv.abh0693

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Technische Universität Dresden. "Using artificial intelligence for early detection and treatment of illnesses." ScienceDaily. ScienceDaily, 20 August 2021. <www.sciencedaily.com/releases/2021/08/210820135346.htm>.

Study supports widespread use of better masks to curb COVID-19 indoors

Date:August 19, 2021Source:University of WaterlooSummary:A new study is highlighting a need for widespread use of better face masks and the importance of good ventilation to mitigate the spread of COVID-19 indoors.Share:

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A new study is highlighting a need for widespread use of better face masks and the importance of good ventilation to mitigate the spread of COVID-19 indoors.

Engineering researchers at the University of Waterloo performed experiments using a mannequin to simulate a seated person breathing in a large room. The studies showed a significant buildup over time of aerosol droplets -- exhaled droplets so tiny they remain suspended and travel through the air -- despite the use of common cloth and blue surgical masks.

"There is no question it is beneficial to wear any face covering, both for protection in close proximity and at a distance in a room," said Serhiy Yarusevych, a professor of mechanical and mechatronics engineering and the leader of the study. "However, there is a very serious difference in the effectiveness of different masks when it comes to controlling aerosols."

Previous research has found that aerosols dispersed by infected people are a source of transmission of the SARS-CoV-2 virus that causes COVID-19, even outside the two-metre social distancing zone widely recommended by public health officials.

The study showed that most common masks, primarily due to problems with fit, filter about 10 per cent of exhaled aerosol droplets. The remaining aerosols are redirected, mostly out the top of the mask where it fits over the nose, and escape into the ambient air unfiltered.

By contrast, higher-quality, more expensive N95 and KN95 masks filtered more than 50 per cent of the exhaled aerosols that can accumulate indoors and spread the COVID-19 virus when inhaled by other people.

Yarusevych, principal investigator in the Fluid Mechanics Research Lab, said the much greater effectiveness of N95 and KN95 masks versus cloth and surgical masks makes a compelling case they should be worn in indoor settings, such as schools and workplaces, as much as possible.

"A lot of this may seem like common sense," he said. "There is a reason, for instance, that medical practitioners wear N95 masks -- they work much better. The novelty here is that we have provided solid numbers and rigorous analysis to support that assumption."

Experiments also quantified the impact of ventilation systems, which circulate and replace air in rooms, on the accumulation of aerosols. Even modest ventilation rates were found to be as effective as the best masks in reducing the risk of transmission.

Ideally, Yarusevych said, the evidence shows that high-quality masks and proper ventilation should be used in combination to mitigate the threat posed by indoor aerosol accumulation as much as possible.

The study, Experimental investigation of indoor aerosol dispersion and accumulation in the context of COVID-19: Effects of masks and ventilation, appears in the journal Physics of Fluids.

Yarusevych collaborated with Sean Peterson, also a Waterloo professor of mechanical and mechatronics engineering, and engineering PhD students Yash Shah and John Kurelek.

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Journal Reference:

• Yash Shah, John W. Kurelek, Sean D. Peterson, Serhiy Yarusevych. Experimental investigation of indoor aerosol dispersion and accumulation in the context of COVID-19: Effects of masks and ventilation. Physics of Fluids, 2021; 33 (7): 073315 DOI: 10.1063/5.0057100

A machine learning approach for predicting risk of schizophrenia using a blood test

Date:August 3, 2021Source:Baylor College of MedicineSummary:An innovative strategy that analyzes a region of the genome offers the possibility of early diagnosis of schizophrenia.Share:

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An innovative strategy that analyzes a region of the genome offers the possibility of early diagnosis of schizophrenia, reports a team led by researchers at Baylor College of Medicine. The strategy applied a machine learning algorithm called SPLS-DA to analyze specific regions of the human genome called CoRSIVs, hoping to reveal epigenetic markers for the condition.

In DNA from blood samples, the team identified epigenetic markers, a profile of methyl chemical groups in the DNA, that differ between people diagnosed with schizophrenia and people without the disease and developed a model that would assess an individual's probability of having the condition. Testing the model on an independent dataset revealed that it can identify schizophrenia patients with 80% accuracy. The study appears in the journal Translational Psychiatry.

"Schizophrenia is a devastating disease that affects about 1% of the world's population," said corresponding author Dr. Robert A. Waterland professor of pediatrics -- nutrition at the USDA/ARS Children's Nutrition Research Center at Baylor and of molecular and human genetics. "Although genetic and environmental components seem to be involved in the condition, current evidence only explains a small portion of cases, suggesting that other factors, such as epigenetic, also could be important."

Epigenetics is a system for molecular marking of DNA -- it tells the different cells in the body which genes to turn on or off in that cell type, therefore epigenetic markers can vary between different normal tissues within one individual. This makes it challenging to assess whether epigenetic changes contribute to diseases involving the brain, like schizophrenia.

To address this obstacle, Waterland and his colleagues had identified in previous work a set of specific genomic regions in which DNA methylation, a common epigenetic marker, differs between people but is consistent across different tissues in one person. They called these genomic regions CoRSIVs for correlated regions of systemic interindividual variation. They proposed that studying CoRSIVs is a novel way to uncover epigenetic causes of disease.

"Because methylation patterns in CoRSIVs are the same in all the tissues of one individual, we can analyze them in a blood sample to infer epigenetic regulation on other parts of the body that are difficult to assess, such as the brain," Waterland said.

Many previous studies have analyzed methylation profiles in blood samples with the goal of identifying epigenetic differences between individuals with schizophrenia, the researchers explained.

"Our study is innovative in various ways," said first author Dr. Chathura J. Gunasekara, computer scientist in the Waterland lab. "We focused on CoRSIVs and also applied for the first time the SPLS-DA machine learning algorithm to analyze DNA methylation. As a scientist interested in applying machine learning to medicine, our findings are very exciting. They not only suggest the possibility of predicting risk of schizophrenia early in life, but also outline a new approach that may be applicable to other diseases."

The current study also is innovative because it considered major potential confounding factors other studies did not take into account. For instance, methylation patterns in blood can be affected by factors such as smoking and taking antipsychotic medications, both of which are common in schizophrenia patients.

"Here, we took various approaches to evaluate whether the methylation patterns we detected at CoRSIVs were affected by medication use and smoking. We were able to rule that out," Waterland said. "This, together with the fact that DNA methylation at CoRSIVs is established very early in life, indicates that the epigenetic differences we identified between schizophrenia patients and healthy individuals were there before the disease was diagnosed, suggesting they may contribute to the condition."

Using this novel approach, the researchers were able to achieve much stronger epigenetic signals associated with schizophrenia than has ever been done before, said the team.

"We consider our study a proof of principle that focusing on CoRSIVs makes epigenetic epidemiology possible," Waterland said.

The following authors also contributed to this work: Eilis Hannon and Jonathan Mill at University of Exeter Medical School, Harry MacKay and Cristian Coarfa at Baylor College of Medicine, Andrew McQuillin at University College London and David St. Clair at University of Aberdeen.

This work was supported by NIH/NIDDK (grant number 1R01DK111522), the Cancer Prevention and Research Institute of Texas (grant number RP170295) and USDA/ARS (CRIS 3092-5-001-059).

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Journal Reference:

• Chathura J. Gunasekara, Eilis Hannon, Harry MacKay, Cristian Coarfa, Andrew McQuillin, David St. Clair, Jonathan Mill, Robert A. Waterland. A machine learning case–control classifier for schizophrenia based on DNA methylation in blood. Translational Psychiatry, 2021; 11 (1) DOI: 10.1038/s41398-021-01496-3

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Baylor College of Medicine. "A machine learning approach for predicting risk of schizophrenia using a blood test." ScienceDaily. ScienceDaily, 3 August 2021. <www.sciencedaily.com/releases/2021/08/210803105532.htm>.

New genes linked to longer reproductive lifespan in women

Date:August 4, 2021Source:University of ExeterSummary:Scientists have identified nearly 300 gene variations that influence reproductive lifespan in women. Additionally, in mice, they have successfully manipulated several key genes associated with these variants to extend their reproductive lifespan. Their findings substantially increase our knowledge of the reproductive ageing process, as well as providing ways to improve the prediction of which women might reach menopause earlier than others.Share:

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The age at which women go through menopause is critical for fertility and impacts healthy ageing in women, but reproductive ageing has been difficult for scientists to study and insights into the underlying biology are limited.

Now, scientists have identified nearly 300 gene variations that influence reproductive lifespan in women. Additionally, in mice, they have successfully manipulated several key genes associated with these variants to extend their reproductive lifespan.

Their findings, published today in Nature, substantially increase our knowledge of the reproductive ageing process, as well as providing ways to improve the prediction ofwhich women might reach menopause earlier than others.

While life expectancy has increased dramatically over the past 150 years, the age at which most women go through natural menopause has remained relatively constant at about 50 years old. Women are born with all the eggs they will ever carry, and these are gradually lost with age. Menopause occurs once most of the eggs have gone, however natural fertility declines substantially earlier.

Co-author Professor Eva Hoffmann, of the University of Copenhagen, said: "It is clear that repairing damaged DNA in eggs is very important for establishing the pool of eggs women are born with and also for how quickly they are lost throughout life. Improved understanding of the biological processes involved in reproductive ageing could lead to improvements in fertility treatment options."

This research has been achieved by a global collaboration involving academics from more than 180 institutions, and jointly led by the University of Exeter, the MRC Epidemiology Unit at the University of Cambridge, the Institute of Biotechnology and Biomedicine at the Universitat Autònoma de Barcelona, and the DNRF Center for Chromosome Stability at the University of Copenhagen. Their findings identify new genetic variations linked to reproductive lifespan, increasing the number known from 56 to 290.

The new discoveries were made possible through analyses of datasets from hundreds of thousands of women from many studies including UK Biobank and 23andMe. Data from 23andMe was provided by customers who have opted-in to participate in research. While the large majority are from women of European ancestry, they also examined data on nearly 80,000 women of East Asian ancestry, and found broadly similar results.

The team discovered that many of the genes involved are linked to processes of DNA repair. They also found that many of these genes are active from before birth, when human egg stores are created, but also throughout life as well. Notable examples are genes from two cell cycle checkpoint pathways -- CHEK1 and CHEK2 -- which regulate a broad variety of DNA repair processes. Knocking out a specific gene (CHEK2) so that it no longer functions, and over-expressing another (CHEK1) to enhance its activity each led to an approximately 25 per cent longer reproductive lifespan in mice. Mouse reproductive physiology differs from humans in key ways, including that mice do not have menopause. However, the study also looked at women who naturally lack an active CHEK2 gene, and found they reach menopause on average 3.5 years later than women with a normally active gene.

Co-author Professor Ignasi Roig, from the Universitat Autònoma de Barcelona, said: "We saw that two of the genes which produce proteins involved in repairing damaged DNA work in opposite ways with respect to reproduction in mice. Female mice with more of the CHEK1 protein are born with more eggs and they take longer to deplete naturally, so reproductive lifespan is extended. However, while the second gene, CHEK2, has a similar effect, allowing eggs to survive longer, but in this case the gene has been knocked out so that no protein is produced suggesting that CHEK2 activation may cause egg death in adult mice."

The genes identified by this work influence the age at natural menopause and can also be used to help predict which women are at highest risk of having menopause at a young age.

Co-author Dr Katherine Ruth, of the University of Exeter, said: "We hope our work will help provide new possibilities to help women plan for the future. By finding many more of the genetic causes of variability in the timing of menopause, we have shown that we can start to predict which women might have earlier menopause and therefore struggle to get pregnant naturally. And because we are born with our genetic variations, we could offer this advice to young women."

The team also examined the health impacts of having an earlier or later menopause by using an approach that tests the effect of naturally-occurring genetic differences. They found that a genetically earlier menopause increases the risk of type 2 diabetes and is linked to poorer bone health and increased risk of fractures. However, it decreases the risk of some types of cancer, such as ovarian and breast cancer, that are known to be sensitive to sex hormones which are at higher levels while a woman is still menstruating.

Co-author Dr John Perry, of the Medical Research Council (MRC) Epidemiology Unit at the University of Cambridge, a senior author on the paper, said: "This research is incredibly exciting. Although there's still a long way to go, by combining genetic analysis in humans with studies in mice, plus examining when these genes are switched on in human eggs, we now know a lot more about human reproductive ageing. It also gives us insights into how to help avoid some health problems that are linked to the timing of menopause."

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Materials provided by University of Exeter. Note: Content may be edited for style and length.

Journal Reference:

• Katherine S. Ruth, Felix R. Day, Jazib Hussain, Ana Martínez-Marchal, Catherine E. Aiken, Ajuna Azad, Deborah J. Thompson, Lucie Knoblochova, Hironori Abe, Jane L. Tarry-Adkins, Javier Martin Gonzalez, Pierre Fontanillas, Annique Claringbould, Olivier B. Bakker, Patrick Sulem, Robin G. Walters, Chikashi Terao, Sandra Turon, Momoko Horikoshi, Kuang Lin, N. Charlotte Onland-Moret, Aditya Sankar, Emil Peter Thrane Hertz, Pascal N. Timshel, Vallari Shukla, Rehannah Borup, Kristina W. Olsen, Paula Aguilera, Mònica Ferrer-Roda, Yan Huang, Stasa Stankovic, Paul R. H. J. Timmers, Thomas U. Ahearn, Behrooz Z. Alizadeh, Elnaz Naderi, Irene L. Andrulis, Alice M. Arnold, Kristan J. Aronson, Annelie Augustinsson, Stefania Bandinelli, Caterina M. Barbieri, Robin N. Beaumont, Heiko Becher, Matthias W. Beckmann, Stefania Benonisdottir, Sven Bergmann, Murielle Bochud, Eric Boerwinkle, Stig E. Bojesen, Manjeet K. Bolla, Dorret I. Boomsma, Nicholas Bowker, Jennifer A. Brody, Linda Broer, Julie E. Buring, Archie Campbell, Harry Campbell, Jose E. Castelao, Eulalia Catamo, Stephen J. Chanock, Georgia Chenevix-Trench, Marina Ciullo, Tanguy Corre, Fergus J. Couch, Angela Cox, Laura Crisponi, Simon S. Cross, Francesco Cucca, Kamila Czene, George Davey Smith, Eco J. C. N. de Geus, Renée de Mutsert, Immaculata De Vivo, Ellen W. Demerath, Joe Dennis, Alison M. Dunning, Miriam Dwek, Mikael Eriksson, Tõnu Esko, Peter A. Fasching, Jessica D. Faul, Luigi Ferrucci, Nora Franceschini, Timothy M. Frayling, Manuela Gago-Dominguez, Massimo Mezzavilla, Montserrat García-Closas, Christian Gieger, Graham G. Giles, Harald Grallert, Daniel F. Gudbjartsson, Vilmundur Gudnason, Pascal Guénel, Christopher A. Haiman, Niclas Håkansson, Per Hall, Caroline Hayward, Chunyan He, Wei He, Gerardo Heiss, Miya K. Høffding, John L. Hopper, Jouke J. Hottenga, Frank Hu, David Hunter, Mohammad A. Ikram, Rebecca D. Jackson, Micaella D. R. Joaquim, Esther M. John, Peter K. Joshi, David Karasik, Sharon L. R. Kardia, Christiana Kartsonaki, Robert Karlsson, Cari M. Kitahara, Ivana Kolcic, Charles Kooperberg, Peter Kraft, Allison W. Kurian, Zoltan Kutalik, Martina La Bianca, Genevieve LaChance, Claudia Langenberg, Lenore J. Launer, Joop S. E. Laven, Deborah A. Lawlor, Loic Le Marchand, Jingmei Li, Annika Lindblom, Sara Lindstrom, Tricia Lindstrom, Martha Linet, YongMei Liu, Simin Liu, Jian’an Luan, Reedik Mägi, Patrik K. E. Magnusson, Massimo Mangino, Arto Mannermaa, Brumat Marco, Jonathan Marten, Nicholas G. Martin, Hamdi Mbarek, Barbara McKnight, Sarah E. Medland, Christa Meisinger, Thomas Meitinger, Cristina Menni, Andres Metspalu, Lili Milani, Roger L. Milne, Grant W. Montgomery, Dennis O. Mook-Kanamori, Antonella Mulas, Anna M. Mulligan, Alison Murray, Mike A. Nalls, Anne Newman, Raymond Noordam, Teresa Nutile, Dale R. Nyholt, Andrew F. Olshan, Håkan Olsson, Jodie N. Painter, Alpa V. Patel, Nancy L. Pedersen, Natalia Perjakova, Annette Peters, Ulrike Peters, Paul D. P. Pharoah, Ozren Polasek, Eleonora Porcu, Bruce M. Psaty, Iffat Rahman, Gad Rennert, Hedy S. Rennert, Paul M. Ridker, Susan M. Ring, Antonietta Robino, Lynda M. Rose, Frits R. Rosendaal, Jacques Rossouw, Igor Rudan, Rico Rueedi, Daniela Ruggiero, Cinzia F. Sala, Emmanouil Saloustros, Dale P. Sandler, Serena Sanna, Elinor J. Sawyer, Chloé Sarnowski, David Schlessinger, Marjanka K. Schmidt, Minouk J. Schoemaker, Katharina E. Schraut, Christopher Scott, Saleh Shekari, Amruta Shrikhande, Albert V. Smith, Blair H. Smith, Jennifer A. Smith, Rossella Sorice, Melissa C. Southey, Tim D. Spector, John J. Spinelli, Meir Stampfer, Doris Stöckl, Joyce B. J. van Meurs, Konstantin Strauch, Unnur Styrkarsdottir, Anthony J. Swerdlow, Toshiko Tanaka, Lauren R. Teras, Alexander Teumer, Unnur Þorsteinsdottir, Nicholas J. Timpson, Daniela Toniolo, Michela Traglia, Melissa A. Troester, Thérèse Truong, Jessica Tyrrell, André G. Uitterlinden, Sheila Ulivi, Celine M. Vachon, Veronique Vitart, Uwe Völker, Peter Vollenweider, Henry Völzke, Qin Wang, Nicholas J. Wareham, Clarice R. Weinberg, David R. Weir, Amber N. Wilcox, Ko Willems van Dijk, Gonneke Willemsen, James F. Wilson, Bruce H. R. Wolffenbuttel, Alicja Wolk, Andrew R. Wood, Wei Zhao, Marek Zygmunt, Zhengming Chen, Liming Li, Lude Franke, Stephen Burgess, Patrick Deelen, Tune H. Pers, Marie Louise Grøndahl, Claus Yding Andersen, Anna Pujol, Andres J. Lopez-Contreras, Jeremy A. Daniel, Kari Stefansson, Jenny Chang-Claude, Yvonne T. van der Schouw, Kathryn L. Lunetta, Daniel I. Chasman, Douglas F. Easton, Jenny A. Visser, Susan E. Ozanne, Satoshi H. Namekawa, Petr Solc, Joanne M. Murabito, Ken K. Ong, Eva R. Hoffmann, Anna Murray, Ignasi Roig, John R. B. Perry. Genetic insights into biological mechanisms governing human ovarian ageing. Nature, 2021; DOI: 10.1038/s41586-021-03779-7

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'Neuroprosthesis' restores words to man with paralysis

Technology could lead to more natural communication for people who have suffered speech loss

Date:July 14, 2021Source:University of California San FranciscoSummary:Researchers have successfully developed a 'speech neuroprosthesis' that has enabled a man with severe paralysis to communicate in sentences, translating signals from his brain to the vocal tract directly into words that appear as text on a screen.Share:

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Word 'hello' on display (stock image).

Credit: © Pavel Ignatov / stock.adobe.com

Researchers at UC San Francisco have successfully developed a "speech neuroprosthesis" that has enabled a man with severe paralysis to communicate in sentences, translating signals from his brain to the vocal tract directly into words that appear as text on a screen.

The achievement, which was developed in collaboration with the first participant of a clinical research trial, builds on more than a decade of effort by UCSF neurosurgeon Edward Chang, MD, to develop a technology that allows people with paralysis to communicate even if they are unable to speak on their own. The study appears July 15 in the New England Journal of Medicine.

"To our knowledge, this is the first successful demonstration of direct decoding of full words from the brain activity of someone who is paralyzed and cannot speak," said Chang, the Joan and Sanford Weill Chair of Neurological Surgery at UCSF, Jeanne Robertson Distinguished Professor, and senior author on the study. "It shows strong promise to restore communication by tapping into the brain's natural speech machinery."

Each year, thousands of people lose the ability to speak due to stroke, accident, or disease. With further development, the approach described in this study could one day enable these people to fully communicate.

Translating Brain Signals into Speech

Previously, work in the field of communication neuroprosthetics has focused on restoring communication through spelling-based approaches to type out letters one-by-one in text. Chang's study differs from these efforts in a critical way: his team is translating signals intended to control muscles of the vocal system for speaking words, rather than signals to move the arm or hand to enable typing. Chang said this approach taps into the natural and fluid aspects of speech and promises more rapid and organic communication.

"With speech, we normally communicate information at a very high rate, up to 150 or 200 words per minute," he said, noting that spelling-based approaches using typing, writing, and controlling a cursor are considerably slower and more laborious. "Going straight to words, as we're doing here, has great advantages because it's closer to how we normally speak."

Over the past decade, Chang's progress toward this goal was facilitated by patients at the UCSF Epilepsy Center who were undergoing neurosurgery to pinpoint the origins of their seizures using electrode arrays placed on the surface of their brains. These patients, all of whom had normal speech, volunteered to have their brain recordings analyzed for speech-related activity. Early success with these patient volunteers paved the way for the current trial in people with paralysis.

Previously, Chang and colleagues in the UCSF Weill Institute for Neurosciences mapped the cortical activity patterns associated with vocal tract movements that produce each consonant and vowel. To translate those findings into speech recognition of full words, David Moses, PhD, a postdoctoral engineer in the Chang lab and one of the lead authors of the new study, developed new methods for real-time decoding of those patterns and statistical language models to improve accuracy.

But their success in decoding speech in participants who were able to speak didn't guarantee that the technology would work in a person whose vocal tract is paralyzed. "Our models needed to learn the mapping between complex brain activity patterns and intended speech," said Moses. "That poses a major challenge when the participant can't speak."

In addition, the team didn't know whether brain signals controlling the vocal tract would still be intact for people who haven't been able to move their vocal muscles for many years. "The best way to find out whether this could work was to try it," said Moses.

The First 50 Words

To investigate the potential of this technology in patients with paralysis, Chang partnered with colleague Karunesh Ganguly, MD, PhD, an associate professor of neurology, to launch a study known as "BRAVO" (Brain-Computer Interface Restoration of Arm and Voice). The first participant in the trial is a man in his late 30s who suffered a devastating brainstem stroke more than 15 years ago that severely damaged the connection between his brain and his vocal tract and limbs. Since his injury, he has had extremely limited head, neck, and limb movements, and communicates by using a pointer attached to a baseball cap to poke letters on a screen.

The participant, who asked to be referred to as BRAVO1, worked with the researchers to create a 50-word vocabulary that Chang's team could recognize from brain activity using advanced computer algorithms. The vocabulary -- which includes words such as "water," "family," and "good" -- was sufficient to create hundreds of sentences expressing concepts applicable to BRAVO1's daily life.

For the study, Chang surgically implanted a high-density electrode array over BRAVO1's speech motor cortex. After the participant's full recovery, his team recorded 22 hours of neural activity in this brain region over 48 sessions and several months. In each session, BRAVO1 attempted to say each of the 50 vocabulary words many times while the electrodes recorded brain signals from his speech cortex.

Translating Attempted Speech into Text

To translate the patterns of recorded neural activity into specific intended words, the other two lead authors of the study, Sean Metzger, MS and Jessie Liu, BS, both bioengineering doctoral students in the Chang Lab used custom neural network models, which are forms of artificial intelligence. When the participant attempted to speak, these networks distinguished subtle patterns in brain activity to detect speech attempts and identify which words he was trying to say.

To test their approach, the team first presented BRAVO1 with short sentences constructed from the 50 vocabulary words and asked him to try saying them several times. As he made his attempts, the words were decoded from his brain activity, one by one, on a screen.

Then the team switched to prompting him with questions such as "How are you today?" and "Would you like some water?" As before, BRAVO1's attempted speech appeared on the screen. "I am very good," and "No, I am not thirsty."

The team found that the system was able to decode words from brain activity at rate of up to 18 words per minute with up to 93 percent accuracy (75 percent median). Contributing to the success was a language model Moses applied that implemented an "auto-correct" function, similar to what is used by consumer texting and speech recognition software.

Moses characterized the early trial results as a proof of principle. "We were thrilled to see the accurate decoding of a variety of meaningful sentences," he said. "We've shown that it is actually possible to facilitate communication in this way and that it has potential for use in conversational settings."

Looking forward, Chang and Moses said they will expand the trial to include more participants affected by severe paralysis and communication deficits. The team is currently working to increase the number of words in the available vocabulary, as well as improve the rate of speech.

Both said that while the study focused on a single participant and a limited vocabulary, those limitations don't diminish the accomplishment. "This is an important technological milestone for a person who cannot communicate naturally," said Moses, "and it demonstrates the potential for this approach to give a voice to people with severe paralysis and speech loss."

Co-authors on the paper include Sean L. Metzger, MS; Jessie R. Liu; Gopala K. Anumanchipalli, PhD; Joseph G. Makin, PhD; Pengfei F. Sun, PhD; Josh Chartier, PhD; Maximilian E. Dougherty; Patricia M. Liu, MA; Gary M. Abrams, MD; and Adelyn Tu-Chan, DO, all of UCSF. Funding sources included National Institutes of Health (U01 NS098971-01), philanthropy, and a sponsored research agreement with Facebook Reality Labs (FRL), which completed in early 2021.

UCSF researchers conducted all clinical trial design, execution, data analysis and reporting. Research participant data were collected solely by UCSF, are held confidentially, and are not shared with third parties. FRL provided high-level feedback and machine learning advice.

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Materials provided by University of California San Francisco. Original written by Robin Marks. Note: Content may be edited for style and length.

Journal Reference:

• David A. Moses, Sean L. Metzger, Jessie R. Liu, Gopala K. Anumanchipalli, Joseph G. Makin, Pengfei F. Sun, Josh Chartier, Maximilian E. Dougherty, Patricia M. Liu, Gary M. Abrams, Adelyn Tu-Chan, Karunesh Ganguly, Edward F. Chang. Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria. New England Journal of Medicine, 2021; 385 (3): 217 DOI: 10.1056/NEJMoa2027540

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University of California San Francisco. "'Neuroprosthesis' restores words to man with paralysis: Technology could lead to more natural communication for people who have suffered speech loss." ScienceDaily. ScienceDaily, 14 July 2021. <www.sciencedaily.com/releases/2021/07/210714174148.htm>.

Scientists reverse age-related memory loss in mice

Date:July 22, 2021Source:University of CambridgeSummary:Scientists have successfully reversed age-related memory loss in mice and say their discovery could lead to the development of treatments to prevent memory loss in people as they age.Share:

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Neurons illustration (stock image).

Credit: © onimate / stock.adobe.com

Scientists at Cambridge and Leeds have successfully reversed age-related memory loss in mice and say their discovery could lead to the development of treatments to prevent memory loss in people as they age.

In a study published today in Molecular Psychiatry, the team show that changes in the extracellular matrix of the brain -- 'scaffolding' around nerve cells -- lead to loss of memory with ageing, but that it is possible to reverse these using genetic treatments.

Recent evidence has emerged of the role of perineuronal nets (PNNs) in neuroplasticity -- the ability of the brain to learn and adapt -- and to make memories. PNNs are cartilage-like structures that mostly surround inhibitory neurons in the brain. Their main function is to control the level of plasticity in the brain. They appear at around five years old in humans, and turn off the period of enhanced plasticity during which the connections in the brain are optimised. Then, plasticity is partially turned off, making the brain more efficient but less plastic.

PNNs contain compounds known as chondroitin sulphates. Some of these, such as chondroitin 4-sulphate, inhibit the action of the networks, inhibiting neuroplasticity; others, such as chondroitin 6-sulphate, promote neuroplasticity. As we age, the balance of these compounds changes, and as levels of chondroitin 6-sulphate decrease, so our ability to learn and form new memories changes, leading to age-related memory decline.

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Researchers at the University of Cambridge and University of Leeds investigated whether manipulating the chondroitin sulphate composition of the PNNs might restore neuroplasticity and alleviate age-related memory deficits.

To do this, the team looked at 20-month old mice -- considered very old -- and using a suite of tests showed that the mice exhibited deficits in their memory compared to six-month old mice.

For example, one test involved seeing whether mice recognised an object. The mouse was placed at the start of a Y-shaped maze and left to explore two identical objects at the end of the two arms. After a short while, the mouse was once again placed in the maze, but this time one arm contained a new object, while the other contained a copy of the repeated object. The researchers measured the amount of the time the mouse spent exploring each object to see whether it had remembered the object from the previous task. The older mice were much less likely to remember the object.

The team treated the ageing mice using a 'viral vector', a virus capable of reconstituting the amount of 6-sulphate chondroitin sulphates to the PNNs and found that this completely restored memory in the older mice, to a level similar to that seen in the younger mice.

Dr Jessica Kwok from the School of Biomedical Sciences at the University of Leeds said: "We saw remarkable results when we treated the ageing mice with this treatment. The memory and ability to learn were restored to levels they would not have seen since they were much younger."

To explore the role of chondroitin 6-sulphate in memory loss, the researchers bred mice that had been genetically-manipulated such that they were only able to produce low levels of the compound to mimic the changes of ageing. Even at 11 weeks, these mice showed signs of premature memory loss. However, increasing levels of chondroitin 6-sulphate using the viral vector restored their memory and plasticity to levels similar to healthy mice.

Professor James Fawcett from the John van Geest Centre for Brain Repair at the University of Cambridge said: "What is exciting about this is that although our study was only in mice, the same mechanism should operate in humans -- the molecules and structures in the human brain are the same as those in rodents. This suggests that it may be possible to prevent humans from developing memory loss in old age."

The team have already identified a potential drug, licensed for human use, that can be taken by mouth and inhibits the formation of PNNs. When this compound is given to mice and rats it can restore memory in ageing and also improves recovery in spinal cord injury. The researchers are investigating whether it might help alleviate memory loss in animal models of Alzheimer's disease.

The approach taken by Professor Fawcett's team -- using viral vectors to deliver the treatment -- is increasingly being used to treat human neurological conditions. A second team at the Centre recently published research showing their use for repairing damage caused by glaucoma and dementia.

The study was funded by Alzheimer's Research UK, the Medical Research Council, European Research Council and the Czech Science Foundation.

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Materials provided by University of Cambridge. The original story is licensed under a Creative Commons License. Note: Content may be edited for style and length.

Journal Reference:

• Sujeong Yang, Sylvain Gigout, Angelo Molinaro, Yuko Naito-Matsui, Sam Hilton, Simona Foscarin, Bart Nieuwenhuis, Chin Lik Tan, Joost Verhaagen, Tommaso Pizzorusso, Lisa M. Saksida, Timothy M. Bussey, Hiroshi Kitagawa, Jessica C. F. Kwok, James W. Fawcett. Chondroitin 6-sulphate is required for neuroplasticity and memory in ageing. Molecular Psychiatry, 2021; DOI: 10.1038/s41380-021-01208-9

Signaling molecule may help prevent Alzheimer's disease

Interleukin-3 may reprogram immune responses in the brain that cause cell death and lead to dementia.

Date:July 14, 2021Source:Massachusetts General HospitalSummary:The main driver of Alzheimer's disease is excessive inflammation in the brain that is triggered by cells called astrocytes and microglia in response to high levels of amyloid beta deposits and tau tangles. New research reveals that a subset of astrocytes releases a molecule called interleukin-3 that instructs microglia to adopt a protective response and clear away amyloid beta deposits and tau tangles. Interleukin-3 may hold promise as a new therapeutic intervention in Alzheimer's disease.Share:

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New research in humans and mice identifies a particular signaling molecule that can help modify inflammation and the immune system to protect against Alzheimer's disease. The work, which was led by investigators at Massachusetts General Hospital (MGH), is published in Nature.

Cognitive decline associated with Alzheimer's disease develops when neurons begin to die. "Neuron death can be caused by improper immune responses and excessive neuroinflammation -- or inflammation in the brain -- triggered by high levels of amyloid beta deposits and tau tangles, two hallmarks of Alzheimer's disease," explains the paper's co-senior author Filip Swirski, PhD, who conducted the work while a principal investigator in the Center for Systems Biology at MGH.

"Once neurons start dying in increasing amounts, brain cells called microglia and astrocytes -- which are normally nurturing cells that clean up debris -- become activated to cause neuroinflammation in an attempt to protect the brain. They are evolutionarily programmed to wipe out a brain region where there is excess neuronal cell death because it may be due to an infection, which must be stopped from spreading," explains co-senior author Rudolph Tanzi, PhD, co-director of the McCance Center for Brain Health at MGH.

In the case of Alzheimer's disease, the neuronal cell death brought on by amyloid beta deposits and tau tangles activates this response. "As neuroinflammation ensues, the amount of cell death is at least 10 times higher than that which was caused by plaques and tangles," says Tanzi. "In fact, without the induction of neuroinflammation, there would be no symptoms of dementia. We know this from 'resilient' brains, in which there are lots of plaques and tangles in an individual's brain but no symptoms at death because there was minimal or no neuroinflammation." Tanzi provides an analogy, noting that amyloid beta is the "match" that lights the spreading "brushfires" of tangles, but only when this leads to increasing numbers of "forest fires" through neuroinflammation that is activated by microglia and astrocytes does one lose enough neurons to suffer cognitive decline and dementia.

This new study in Nature revealed that a subset of astrocytes actually tries to put out the fire by releasing a molecule called interleukin-3 (IL-3), which then converts killer microglial cells back into nurturing and protective cells that no longer wipe out neurons and instead focus on cleaning out amyloid beta deposits and tau tangles.

"There may be important clinical implications to knowing that astrocytes talk to microglia via IL-3 to educate the microglia and help them decrease the severity of Alzheimer's disease," says Swirski. "We can now think about how to use IL-3 to not only help curb the neuroinflammation that carries out the bulk of neuronal cell death in Alzheimer's disease, but also to entice microglia to once again take on the beneficial task of clearing away the deposits and tangles that are the initiating pathology of Alzheimer's disease."

"It was surprising to find IL-3 in the brain," says first author Cameron McAlpine, PhD, then an instructor in the Center for Systems Biology. "Our findings suggest that communication between astrocytes and microglia, via IL-3, is an important mechanism that wards off Alzheimer's disease by instructing microglia to adapt protective functions. With further study, IL-3 signaling may provide a new therapeutic opportunity to combat neurological diseases."

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Materials provided by Massachusetts General Hospital. Original written by Tracy Hampton. Note: Content may be edited for style and length.

Journal Reference:

• Cameron S. McAlpine, Joseph Park, Ana Griciuc, Eunhee Kim, Se Hoon Choi, Yoshiko Iwamoto, Máté G. Kiss, Kathleen A. Christie, Claudio Vinegoni, Wolfram C. Poller, John E. Mindur, Christopher T. Chan, Shun He, Henrike Janssen, Lai Ping Wong, Jeffrey Downey, Sumnima Singh, Atsushi Anzai, Florian Kahles, Mehdi Jorfi, Paolo Fumene Feruglio, Ruslan I. Sadreyev, Ralph Weissleder, Benjamin P. Kleinstiver, Matthias Nahrendorf, Rudolph E. Tanzi, Filip K. Swirski. Astrocytic interleukin-3 programs microglia and limits Alzheimer’s disease. Nature, 2021; DOI: 10.1038/s41586-021-03734-6

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Massachusetts General Hospital. "Signaling molecule may help prevent Alzheimer's disease: Interleukin-3 may reprogram immune responses in the brain that cause cell death and lead to dementia.." ScienceDaily. ScienceDaily, 14 July 2021. <www.sciencedaily.com/releases/2021/07/210714110528.htm>.

Newfound human brain cell type helps center people in mental maps

Experiments in virtual reality shed light on the cellular mechanisms underlying navigation and memory in humans

Date:July 14, 2021Source:Columbia University School of Engineering and Applied ScienceSummary:A previously unknown kind of human brain cell appears to help people center themselves in their personal maps of the world, according to a new study from neuroscientists. This discovery shed light on the cellular mechanisms underlying navigation and memory in humans, as well as what parts of the brain might get disrupted during the kinds of memory impairments common in neurodegenerative diseases such as Alzheimer's.Share:

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A previously unknown kind of human brain cell appears to help people center themselves in their personal maps of the world, according to a new study from neuroscientists at Columbia Engineering. This discovery sheds light on the cellular mechanisms underlying navigation and memory in humans, as well as what parts of the brain might get disrupted during the kinds of memory impairments common in neurodegenerative diseases such as Alzheimer's.

There are two strategies with which humans and animals navigate and orient themselves. One involves locating places, distances and directions in "allocentric" or other-centered frames of reference rooted in the external world. The other strategy involves "egocentric" frames of reference that are centered on the self.

Whenever you use a mobile phone app to find driving directions, it will likely employ both these modes of navigation. When you first type in an address, it will normally show you the address on a map from an allocentric perspective, with 'north' at the top and 'south' at the bottom. When you then go to route view, it will switch to an egocentric perspective where 'ahead' is at the top and 'behind' is at the bottom.

Scientists first discovered brain cells linked with allocentric frames of reference in rats in 1971 -- "place cells" that may, for example, indicate that one is located in the northeast corner of an area. Other allocentric spatial cell types include head-direction cells that may activate whenever one is navigating south, or border cells that may respond when a boundary is located to the west.

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In the past decade, researchers began investigating how rat brains mapped egocentric frames of reference. Two years ago, scientists at Dartmouth College in Hanover, New Hampshire, identified a brain region in rats called the postrhinal cortex in which egocentrically tuned cells are abundant. However, it remained poorly understood what brain cells formed the basis of egocentric spatial maps in humans.

"In humans it is only rarely possible to directly record the activity of single neurons from the brain, due to ethical reasons," said Lukas Kunz, a postdoctoral research scientist at Columbia University's Department of Biomedical Engineering and first author of the new study. "There are techniques like fMRI or EEG, which allow us to indirectly measure neural activity from healthy human brains, but this neural activity reflects the sum activity of millions of neurons, which does not allow for direct conclusions about the working principles of single neurons."

In the new study, neuroscientists from the United States and Germany investigated 15 epilepsy patients at the University of Freiburg's Medical Center in Germany. These volunteers were implanted with electrodes to help doctors monitor their disorder.

The researchers asked the volunteers to perform computer tasks that explored their ability to navigate through virtual environments and to remember where many different objects were located there. At the same time, the scientists recorded the activity of more than 1,400 single neurons in multiple brain regions across all the participants.

The scientists identified more than 160 neurons that behaved like egocentric spatial cell types, activating when specific parts of the virtual environment were ahead, behind, to the left, or to the right of the patients, or when points in space were close to or far away from the patients.

"We are now the first to report egocentric spatial cell types in humans," Kunz said. The scientists published their study, "A neural code for egocentric spatial maps in the human medial temporal lobe," in the journal Neuron on July 14, 2021.

These "egocentric bearing cells" likely encode spatial information on a mental map centered on each person. "This is presumably important for everyday life, when humans try to orient themselves in their environments and when they navigate along routes," said Joshua Jacobs, associate professor of biomedical engineering at Columbia Engineering and senior author of the study.

These egocentric bearing cells were particularly ample in the parahippocampal cortex, a region located deep within the brain that prior work suggested is the human equivalent of the rodent postrhinal cortex. Egocentric bearing cells comprised about 25% of all neurons in the parahippocampal cortex. "Previous studies had shown that patients with damage to this brain region are disoriented, presumably because their egocentric bearing cells were affected," Kunz said.

The researchers also found these egocentric bearing cells showed increases in activity when the patients used their memory to successfully recall the locations of objects they had found in the virtual environments. "This suggests these cells are not only relevant for navigation, but also play a role in correctly remembering past experiences," Kunz said.

"Memories consist of multiple different elements, such as a specific event, the place where the event happened, and the time when the event happened," Kunz said. "We believe that there are different neural systems for the different components of these memories. Egocentric bearing cells are presumably particularly involved in processing the spatial information of the memories."

These findings may illuminate what might go wrong in people with memory deficits, including patients with neurodegenerative diseases such as Alzheimer's. "Their egocentric bearing cells may not function correctly, or may have been destroyed for some reason, such as a stroke, a brain tumor, or dementia," Jacobs said.

These new findings do not answer how one might deal with such memory impairments. "There is still a lot of research to do before memory impairments can be treated successfully," Kunz cautioned.

In the future, the researchers want to see why exactly any given egocentric bearing cell is tuned to whatever point in space it is focused on. Currently, Kunz and his colleagues assume that multiple different spatial cues, such as objects, spatial boundaries and landmarks, combine to influence the position of these reference points. The scientists can examine the influence these cues have on the location of these reference points by removing these cues from environments during experiments.

"Another important question is how egocentric bearing cells interact with allocentric spatial cell types, Kunz said. "We currently hypothesize that egocentric bearing cells provide essential input to allocentric spatial cell types. By understanding this, future studies could explain how the tuning of allocentric spatial cell types is influenced by the functioning of egocentric bearing cells."

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Materials provided by Columbia University School of Engineering and Applied Science. Note: Content may be edited for style and length.

Journal Reference:

• Lukas Kunz, Armin Brandt, Peter C. Reinacher, Bernhard P. Staresina, Eric T. Reifenstein, Christoph T. Weidemann, Nora A. Herweg, Ansh Patel, Melina Tsitsiklis, Richard Kempter, Michael J. Kahana, Andreas Schulze-Bonhage, Joshua Jacobs. A neural code for egocentric spatial maps in the human medial temporal lobe. Neuron, 2021; DOI: 10.1016/j.neuron.2021.06.019

For pediatric patients with Crohn's disease, factors associated with statural growth differ by sex

Date:July 9, 2021Source:Weill Cornell MedicineSummary:Growth impairment, a common complication of Crohn's disease in children, occurs more often in males than females, but the reasons are unclear. Now, a physician-scientists have found that factors associated with statural growth differ by sex.Share:

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Growth impairment, a common complication of Crohn's disease in children, occurs more often in males than females, but the reasons are unclear. Now, a physician-scientist from Weill Cornell Medicine and NewYork-Presbyterian and colleagues at eight other centers have found that factors associated with statural growth differ by sex. Their recent publication, identified as the "Editor's Choice / Leading Off" article and receiving a mention on the cover of the June issue of Inflammatory Bowel Diseases, underscores the need for investigating and developing sex-specific treatment strategies for children with Crohn's disease, an approach that is not currently part of the pediatric Crohn's disease management algorithm.

The Growth Study is an ongoing prospective, multicenter, longitudinal cohort study investigating sex differences in growth impairment in children with Crohn's disease. For their current analysis, lead author Dr. Neera Gupta, principal investigator for The Growth Study, director of research for the Pediatric Inflammatory Bowel Disease (PIBD) Program and an associate professor of pediatrics at Weill Cornell Medicine and a pediatric gastroenterologist at NewYork-Presbyterian Komansky Children's Hospital, and colleagues examined a range of variables associated with statural growth by sex for 113 children with Crohn's disease, such as disease characteristics, patient-reported symptoms at onset and the use of certain medications.

Among 41 female patients, an initial classification of IBD as Crohn's disease or perianal disease at diagnosis were associated with better growth. However, patient-reported joint pain at symptom onset or the use of probiotics or azathioprine/6-mercaptopurine were associated with worse growth.

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Variables associated with statural growth were markedly different for 72 male patients. Patient-reported poor growth at symptom onset or the use of infliximab, biologics, methotrexate or vitamin D were associated with better growth. In contrast, an initial classification of IBD as Crohn's disease or patient-reported anorexia or mouth sores at symptom onset were associated with worse growth.

The authors noted that female patients appear to grow better independent of disease severity/inflammatory burden and medication interventions. Their findings suggest sex-specific molecular pathways lead to growth impairment in children with Crohn's disease, and that there may be a difference in the response of these sex-specific molecular pathways to current medications used to treat pediatric Crohn's disease. Sex will likely be an important future determinant of treatment decisions, which will represent a major advancement in clinical decision making for pediatric Crohn's disease.

"Through the Growth Study, we aim to transform the care of pediatric patients with Crohn's disease by providing an evidence-based approach for the appropriate early introduction of aggressive therapy in patients with high risk for each sex because there is only a narrow therapeutic window available for intervention to improve statural growth," the authors wrote.

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Materials provided by Weill Cornell Medicine. Note: Content may be edited for style and length.

Journal Reference:

• Neera Gupta, Robert H Lustig, Howard Andrews, Ranjana Gokhale, Alka Goyal, Ashish S Patel, Stephen Guthery, Francisco Sylvester, Leah Siebold, Cheng-Shiun Leu. Clinical Variables Associated With Statural Growth in Pediatric Crohn’s Disease Differ by Sex (The Growth Study). Inflammatory Bowel Diseases, 2021; 27 (6): 751 DOI: 10.1093/ibd/izaa220

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Weill Cornell Medicine. "For pediatric patients with Crohn's disease, factors associated with statural growth differ by sex." ScienceDaily. ScienceDaily, 9 July 2021. <www.sciencedaily.com/releases/2021/07/210709193616.htm>.

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Transient pacemaker harmlessly dissolves in body

Wireless, fully implantable device gives temporary pacing without requiring removal

Date:June 28, 2021Source:Northwestern UniversitySummary:The thin, flexible, lightweight device could be used in patients who need temporary pacing after cardiac surgery or while waiting for a permanent pacemaker. All components of the pacemaker are biocompatible and naturally absorb into the body's biofluids over the course of five to seven weeks, without needing surgical extraction.Share:

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Researchers at Northwestern and George Washington (GW) universities have developed the first-ever transient pacemaker -- a wireless, battery-free, fully implantable pacing device that disappears after it's no longer needed.

The thin, flexible, lightweight device could be used in patients who need temporary pacing after cardiac surgery or while waiting for a permanent pacemaker. All components of the pacemaker are biocompatible and naturally absorb into the body's biofluids over the course of five to seven weeks, without needing surgical extraction.

The device wirelessly harvests energy from an external, remote antenna using near-field communication protocols -- the same technology used in smartphones for electronic payments and in RFID tags. This eliminates the need for bulky batteries and rigid hardware, including wires (or leads). Not only can leads introduce infections, they also can become enveloped in scar tissue, causing further damage when removed.

The study will be published June 28 in the journal Nature Biotechnology. The paper demonstrates the device's efficacy across a series of large and small animal models.

"Hardware placed in or near the heart creates risks for infection and other complications," said Northwestern's John A. Rogers, who led the device's development. "Our wireless, transient pacemakers overcome key disadvantages of traditional temporary devices by eliminating the need for percutaneous leads for surgical extraction procedures -- thereby offering the potential for reduced costs and improved outcomes in patient care. This unusual type of device could represent the future of temporary pacing technology."

"Sometimes patients only need pacemakers temporarily, perhaps after an open heart surgery, heart attack or drug overdose," said Dr. Rishi Arora, a cardiologist at Northwestern Medicine who co-led the study. "After the patient's heart is stabilized, we can remove the pacemaker. The current standard of care involves inserting a wire, which stays in place for three to seven days. These have potential to become infected or dislodged."

"The transient electronics platform opens an entirely new chapter in medicine and biomedical research," said GW's Igor Efimov, who co-led the study with Rogers and Arora. "The bioresorbable materials at the foundation of this technology make it possible to create whole host of diagnostic and therapeutic transient devices for monitoring progression of diseases and therapies, delivering electrical, pharmacological, cell therapies, gene reprogramming and more."

Rogers is the Louis Simpson and Kimberly Querrey Professor of Materials Science and Engineering, Biomedical Engineering and Neurological Surgery in the McCormick School of Engineering and Feinberg School of Medicine and the director of the Querrey Simpson Institute for Bioelectronics. Arora is a professor of medicine at Feinberg and co-director of the Center for Arrhythmia Research. Efimov is the Alisann and Terry Collins Professor of Biomedical Engineering at GW.

Ditching restrictive, risky leads

Currently, to set up a temporary pacing after open heart surgery, surgeons must sew on temporary pacemaker electrodes on the heart muscle during surgery. These have leads that exit the front of a patient's chest, connecting to an external pacing box that delivers a current to control the heart's rhythm.

When the temporary pacemaker is no longer needed, physicians remove the pacemaker electrodes. Although uncommon, potential complications of implanted temporary pacemakers include infection, dislodgement, torn or damaged tissues, bleeding and blood clots.

With Northwestern and GW's transient pacemaker, surgeons and patients can sidestep this potentially risky procedure. The fully implantable device is light and thin -- 250 microns thick and weighing less than half a gram. Soft and flexible, it encapsulates electrodes that softly laminate onto the heart's surface to deliver an electrical pulse.

"Instead of using wires that can get infected and dislodged, we can implant this leadless biocompatible pacemaker," Arora said. "The circuitry is implanted directly on the surface of the heart, and we can activate it remotely. Over a period of weeks, this new type of pacemaker 'dissolves' or degrades on its own, thereby avoiding the need for physical removal of the pacemaker electrodes. This is potentially a major victory for post-operative patients.

"With further modifications, it eventually may be possible to implant such bioresorbable pacemakers through a vein in the leg or arm," he added. "In this instance, it also may be possible to provide temporary pacing to patients who have suffered a heart attack or to patients undergoing catheter-based procedures, such as trans-catheter aortic valve replacement."

Prioritizing patient comfort

Northwestern Medicine cardiac surgeon Dr. Duc Thinh Pham, who was not involved with the research, imagines a transient pacemaker undoubtedly would make his patients more comfortable. With current pacemakers, patients often feel discomfort for days after the leads are inserted. Then, they must limit their movements and activities in order to prevent the leads from dislodging.

"This transient pacemaker is brilliant," said Pham, who has performed more than 2,000 cardiac surgeries throughout his career. "In addition to addressing the primary issue of occasional post-cardiac surgery patients needing temporary pacing due to blockages or arrhythmias, the device addresses the secondary issue of patient comfort, ability to move freely and rehabilitate. If successful, this device will greatly improve a patient's post-operative course."

Disappearing act

This is the second example of bioresorbable electronic medicine from the Rogers lab, which has been studying transient electronics for over a decade. In 2018, Rogers and colleagues demonstrated the world's first bioresorbable electronic device -- a biodegradable implant that speeds nerve regeneration. The team's bioresorbable devices are completely harmless -- similar to absorbable stitches. After fully degrading, the devices completely disappear through the body's natural biological processes.

"There is clearly a need for better temporary cardiac pacemakers," said Dr. Bradley Knight, the Chester C. and Deborah M. Cooley Distinguished Professor of Cardiology at Feinberg and coauthor of the study. "When I first learned about the bioresorbable nerve stimulator, I contacted Professor Rogers to explore the possibility of using this technology to pace the heart. He had already started working with Dr. Efimov to develop a small version of a bioresorbable pacemaker as a proof of concept. We then worked with both teams to develop a larger version of a bioresorbable, leadless, cardiac pacemaker that could be effective on a human scale. It's a great example of what we can create at Northwestern by bridging the expertise in engineering and medicine."

Depending on the patient, a temporary pacemaker might be needed anywhere from a couple days to several weeks. By varying the composition and thickness of the materials in the device, Rogers' team can control the precise number of days it remains functional before dissolving.

"We build these devices out of different types of safe, bioresorbable materials and in optimized architectures to ensure stable operation over a time period somewhat longer than is clinically necessary," Rogers said. "We can tailor the devices to address a broad spectrum of relevant lifetimes. Transient technologies, in general, could someday provide therapy or treatment for a wide variety of medical conditions -- serving, in a sense, as an engineering form of medicine."

Story Source:

Materials provided by Northwestern University. Original written by Amanda Morris. Note: Content may be edited for style and length.

Journal Reference:

• Yeon Sik Choi, Rose T. Yin, Anna Pfenniger, Jahyun Koo, Raudel Avila, K. Benjamin Lee, Sheena W. Chen, Geumbee Lee, Gang Li, Yun Qiao, Alejandro Murillo-Berlioz, Alexi Kiss, Shuling Han, Seung Min Lee, Chenhang Li, Zhaoqian Xie, Yu-Yu Chen, Amy Burrell, Beth Geist, Hyoyoung Jeong, Joohee Kim, Hong-Joon Yoon, Anthony Banks, Seung-Kyun Kang, Zheng Jenny Zhang, Chad R. Haney, Alan Varteres Sahakian, David Johnson, Tatiana Efimova, Yonggang Huang, Gregory D. Trachiotis, Bradley P. Knight, Rishi K. Arora, Igor R. Efimov, John A. Rogers. Fully implantable and bioresorbable cardiac pacemakers without leads or batteries. Nature Biotechnology, 2021; DOI: 10.1038/s41587-021-00948-x

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Northwestern University. "Transient pacemaker harmlessly dissolves in body: Wireless, fully implantable device gives temporary pacing without requiring removal." ScienceDaily. ScienceDaily, 28 June 2021. <www.sciencedaily.com/releases/2021/06/210628114142.htm>.

Had COVID-19? One vaccine dose enough; boosters for all, study says

Date:June 23, 2021Source:American Chemical SocietySummary:A new study supports increasing evidence that people who had COVID-19 need only one vaccine dose, and that boosters could be necessary for everyone in the future.Share:

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Two mRNA vaccines against COVID-19 have proven safe and effective in clinical trials, as well as in the millions of people who have been vaccinated so far. But how prior SARS-CoV-2 infection affects vaccine response, and how long that response lasts, are still uncertain. Now, a new study in ACS Nano supports increasing evidence that people who had COVID-19 need only one vaccine dose, and that boosters could be necessary for everyone in the future.

In clinical trials, the Pfizer-BioNTech and Moderna COVID-19 vaccines were about 95% effective in protecting against symptomatic infections. Both mRNA vaccines trigger the immune system to produce antibodies against the SARS-CoV-2 spike protein receptor binding domain (RBD), and two doses are necessary to provide immunity in people who haven't previously had COVID-19. However, the clinical trials included very few people who had already recovered from the disease, so the immune response of these individuals is less well known. Also, the time course of antibody development in both groups, and how long virus-neutralizing antibodies persist, haven't been well characterized. So Otto Yang and colleagues wanted to compare antibody levels, quality and persistence after one and two doses of mRNA vaccine in people with or without prior SARS-CoV-2 infection.

The researchers used an enzyme-linked immunosorbent assay (ELISA) to measure antibodies against the RBD in people who received the Pfizer-BioNTech or Moderna vaccine, and in unvaccinated people soon after mild or severe COVID-19 cases. In the 28 participants without prior infection, one dose of either vaccine triggered antibody levels similar to those seen after mild COVID-19 infections, whereas two doses were required to obtain anti-RBD antibodies approaching those observed after severe cases. In contrast, in 36 participants who had COVID-19 prior to vaccination, the first dose produced a vigorous antibody response similar to severe natural infection, but the second dose provided no additional increase in antibody levels. The quality of antibodies, indicated by their ability to neutralize the SARS-CoV-2 spike protein and their potency, followed similar patterns. After the second vaccine dose, antibody levels waned in both groups comparably to natural infection, resulting in an average loss of 90% within 85 days. Although more research on T cell responses to the vaccines is needed, this result suggests that booster vaccinations will likely be required for everyone, the researchers say.

The authors acknowledge funding from the AIDS Healthcare Foundation and private philanthropic donors, the University of California, Los Angeles (UCLA) AIDS Institute, the National Institutes of Health, the James B. Pendleton Charitable Trust and the McCarthy Family Foundation.

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Materials provided by American Chemical Society. Note: Content may be edited for style and length.

Journal Reference:

• F. Javier Ibarrondo, Christian Hofmann, Jennifer A. Fulcher, David Goodman-Meza, William Mu, Mary Ann Hausner, Ayub Ali, Arumugam Balamurugan, Ellie Taus, Julie Elliott, Paul Krogstad, Nicole H. Tobin, Kathie G. Ferbas, Scott G. Kitchen, Grace M. Aldrovandi, Anne W. Rimoin, Otto O. Yang. Primary, Recall, and Decay Kinetics of SARS-CoV-2 Vaccine Antibody Responses. ACS Nano, 2021; DOI: 10.1021/acsnano.1c03972

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American Chemical Society. "Had COVID-19? One vaccine dose enough; boosters for all, study says." ScienceDaily. ScienceDaily, 23 June 2021. <www.sciencedaily.com/releases/2021/06/210623091222.htm>.

For Transplant Recipients, Third Time May Be the Charm for Better COVID Vaccine Protection

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Those Who Had COVID-19 May Only Need One Vaccine Dose, Study Suggests

Apr. 15, 2021 — Those recovered from COVID-19 had a robust antibody response after the first mRNA vaccine dose, but little immune benefit after the second dose, according to new research. The findings suggest only a ...

Messenger RNA Vaccines: Reducing Infection from Asymptomatic COVID-19 Carriers?

Mar. 11, 2021 — Ten days after receiving a second dose of a messenger RNA, or mRNA, vaccine for COVID-19, patients without COVID-19 symptoms are far less likely to test positive and unknowingly spread COVID-19, ...

Chinese Phase 2 Trial Finds COVID-19 Vaccine Is Safe and Induces an Immune Response

July 20, 2020 — A phase 2 randomized controlled trial of a recombinant adenovirus type-5-vectored COVID-19 vaccine (Ad5-vectored COVID-19 vaccine) was conducted in China in April 2020 and involved more than 500 ...

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Gene discovery may hold key to better therapies for OCD

Date:June 28, 2021Source:Columbia University Irving Medical CenterSummary:New research finds that some cases of OCD are caused by damaging gene variants that, while rare, provide a needed starting point for the development of better therapeutics.

In the first analysis of its kind, researchers at Columbia University Vagelos College of Physicians and Surgeons and several other institutions have linked distinct patterns of genetic mutations with obsessive-compulsive disorder (OCD) in humans.

The work, published online June 28 in Nature Neuroscience, confirms the validity of targeting specific genes to develop new OCD treatments and points toward novel avenues for studying this often debilitating condition.

OCD, which affects 1% to 2% of the population, often runs in families and genes are known to play a large role in determining who develops the disease. However, the identity of many OCD genes remains unknown.

"Many neurological diseases are influenced by strongly acting mutations which can cause disease by themselves," says David Goldstein, PhD, director of the Institute for Genomic Medicine at Columbia and a senior author on the new paper. "These mutations are individually very rare but important to find because they can provide a starting point for the development of therapeutics that target precise underlying causes of disease."

Although strongly acting mutations have been hypothesized to exist in OCD, statistically reliable evidence has been difficult to obtain.

Most previous studies on the genetics of OCD have used a "candidate gene" approach, in which researchers focus on plausible genes that might be involved in pathogenesis and look for genetic signatures of risk. Although that approach has had some successes, it can lead to challenges in statistical interpretation and can miss unexpected genes. As a result, both funding agencies and the pharmaceutical industry increasingly focus on genome-wide analyses that can securely implicate genes in disease risk.

"The solution to the problem is to study all the genes in the genome at the same time and ask whether any of them have significant evidence of influencing risk. That had not been done yet at scale in OCD," says Goldstein.

In collaboration with Gerald Nestadt, MBBCh, a psychiatrist at Johns Hopkins University with access to a cohort of OCD patients, Goldstein's team took this genome wide approach, which uses high-throughput sequencing and computational biology techniques to identify relevant genes anywhere in the genome.

The investigators looked at genes that encode protein using whole exome sequencing in more than 1,300 OCD patients and compared them to similarly large control groups. The multi-institution collaboration also included scientists from the University of North Carolina at Chapel Hill, the David Geffen School of Medicine in Los Angeles, Harvard Medical School, and SUNY Downstate Medical Center in Brooklyn.

The analysis showed a strong correlation between OCD and rare mutations, particularly in a gene called SLITRK5 that had been previously linked to OCD in candidate-gene studies.

Goldstein expects that the new data on SLITRK5 will encourage pharmaceutical companies and translational researchers to develop drugs that target this gene.

The study also identified a specific pattern of variation in other genes. "When you look at genes that do not tolerate variation in the human population, those are the genes most likely to cause disease, and with OCD, we see an overall increased burden of damaging mutations in those genes compared to controls," Goldstein says. "That's telling us that there are more OCD genes to be found and where to find them."

For patients suffering from OCD and their doctors, new treatments can't come too soon. OCD causes uncontrollable, recurring thought patterns and behaviors that interfere with patients' daily lives.

"OCD is a disabling disorder that is twice as common as schizophrenia," says H. Blair Simpson, MD, PhD, professor of psychiatry at Columbia University Vagelos College of Physicians and Surgeons and director of the Center for OCD & Related Disorders at New York State Psychiatric Institute, who was not involved with the new study.

Two available treatments, serotonin reuptake inhibiting drugs and cognitive-behavioral therapy, are highly effective, Simpson adds, but only work on about half of patients. "Thus, these genetic findings are very exciting; they indicate that the promise of precision medicine could include OCD, ultimately transforming how we diagnose and treat this disorder."

Story Source:

Materials provided by Columbia University Irving Medical Center. Note: Content may be edited for style and length.

Journal Reference:

• Mathew Halvorsen, Jack Samuels, Ying Wang, Benjamin D. Greenberg, Abby J. Fyer, James T. McCracken, Daniel A. Geller, James A. Knowles, Anthony W. Zoghbi, Tess D. Pottinger, Marco A. Grados, Mark A. Riddle, O. Joseph Bienvenu, Paul S. Nestadt, Janice Krasnow, Fernando S. Goes, Brion Maher, Gerald Nestadt, David B. Goldstein. Exome sequencing in obsessive–compulsive disorder reveals a burden of rare damaging coding variants. Nature Neuroscience, 2021; DOI: 10.1038/s41593-021-00876-8

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Columbia University Irving Medical Center. "Gene discovery may hold key to better therapies for OCD." ScienceDaily. ScienceDaily, 28 June 2021. <www.sciencedaily.com/releases/2021/06/210628114114.htm>.

Scientists develop simple blood test for early detection of Alzheimer's disease

Date:June 28, 2021Source:Hong Kong University of Science and TechnologySummary:An international research team has developed a simple but robust blood test from Chinese patient data for early detection and screening of Alzheimer's disease (AD) with an accuracy level of over 96%.

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An international research team led by HKUST has developed a simple but robust blood test from Chinese patient data for early detection and screening of Alzheimer's disease (AD) for the first time, with an accuracy level of over 96%.

Currently, doctors mainly rely on cognitive tests to diagnose a person with AD. Besides clinical assessment, brain imaging and lumbar puncture are the two most commonly used medical procedures to detect changes in the brain caused by AD. However, these methods are expensive, invasive, and frequently unavailable in many countries.

Now, a team led by Prof. Nancy IP, Vice-President for Research and Development at HKUST, has identified 19 out of the 429 plasma proteins associated with AD to form a biomarker panel representative of an "AD signature" in the blood. Based on this panel, the team has developed a scoring system that distinguishes AD patients from healthy people with more than 96% accuracy. This system can also differentiate among the early, intermediate, and late stages of AD, and can be used to monitor the progression of the disease over time. These exciting findings have led to the development of a high-performance, blood-based test for AD, and may also pave the way to novel therapeutic treatments for the disease.

"With the advancement of ultrasensitive blood-based protein detection technology, we have developed a simple, noninvasive, and accurate diagnostic solution for AD, which will greatly facilitate population-scale screening and staging of the disease," said Prof. Nancy Ip, Morningside Professor of Life Science and the Director of the State Key Laboratory of Molecular Neuroscience at HKUST.

The work was conducted in collaboration with researchers at University College London and clinicians in local hospitals including the Prince of Wales Hospital and Queen Elizabeth Hospital. The discovery was made using the proximity extension assay (PEA) -- a cutting-edge ultrasensitive and high-throughput protein measurement technology, to examine the levels of over 1,000 proteins in the plasma of AD patients in Hong Kong.

As the most comprehensive study of blood proteins in AD patients to date, the work has recently been published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, and has also been featured and actively discussed on different scholarly exchange platforms on AD research such as Alzforum.

AD, which affects over 50 million people worldwide, involves the dysfunction and loss of brain cells. Its symptoms include progressive memory loss as well as impaired movement, reasoning, and judgment. While patients often only seek medical attention and are diagnosed when they have memory problems, AD affects the brain at least 10-20 years before symptoms appear.

Story Source:

Materials provided by Hong Kong University of Science and Technology. Note: Content may be edited for style and length.

Journal Reference:

• Yuanbing Jiang, Xiaopu Zhou, Fanny C. Ip, Philip Chan, Yu Chen, Nicole C.H. Lai, Kit Cheung, Ronnie M.N. Lo, Estella P.S. Tong, Bonnie W.Y. Wong, Andrew L.T. Chan, Vincent C.T. Mok, Timothy C.Y. Kwok, Kin Y. Mok, John Hardy, Henrik Zetterberg, Amy K.Y. Fu, Nancy Y. Ip. Large‐scale plasma proteomic profiling identifies a high‐performance biomarker panel for Alzheimer's disease screening and staging. Alzheimer's & Dementia, 2021; DOI: 10.1002/alz.12369

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Hong Kong University of Science and Technology. "Scientists develop simple blood test for early detection of Alzheimer's disease." ScienceDaily. ScienceDaily, 28 June 2021. <www.sciencedaily.com/releases/2021/06/210628124947.htm>.

No lab required: New technology can diagnose infections in minutes

Patients will be able to receive confirmed diagnosis at the doctor's office

Date:June 24, 2021Source:McMaster UniversitySummary:Engineering, biochemistry and medical researchers at McMaster University have combined their skills to create a hand-held rapid test for bacterial infections that can produce accurate, reliable results in less than an hour, eliminating the need to send samples to a lab.

The idea of visiting the doctor's office with symptoms of an illness and leaving with a scientifically confirmed diagnosis is much closer to reality because of new technology developed by researchers at McMaster University.

Engineering, biochemistry and medical researchers from across campus have combined their skills to create a hand-held rapid test for bacterial infections that can produce accurate, reliable results in less than an hour, eliminating the need to send samples to a lab.

Their proof-of-concept research, published today in the journal Nature Chemistry, specifically describes the test's effectiveness in diagnosing urinary tract infections from real clinical samples. The researchers are adapting the test to detect other forms of bacteria and for the rapid diagnosis of viruses, including COVID-19. They also plan to test its viability for detecting markers of cancer.

"It's going to mean that patients can get better treatment, faster results and avoid serious complications. It can also avoid the unnecessary use of antibiotics, which is something that can buy us time in the battle against antimicrobial resistance," says Leyla Soleymani, the paper's co-corresponding author and an associate professor of engineering physics.

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"This will give doctors the science to support what they already suspect based on their skills and experience," says co-corresponding author Yingfu Li, a professor of biochemistry and biomedical sciences.

The new DNA-based technology uses a handheld device similar to a blood-glucose monitor. A microchip analyzes a droplet of bodily fluid such as blood, urine or saliva, using molecules that can detect the specific protein signature of an infection. The device, about the size of a USB stick, plugs into a smartphone, which displays the result.

The invention combines electrochemical engineering technology developed by Soleymani and her team with biochemical technology developed by Li and his colleague Dingran Chang. They worked with infectious disease clinician Marek Smeija, a professor of medicine who provided samples from real patients, and with Todd Hoare, a professor of chemical engineering.

"As scientists, we want to enable things," says Li, "We are knowledgeable in different scientific and engineering principles, and when you put them together to help people, that's a special feeling. Having the chance to impact society is the reason we all do this work."

Existing practice typically requires sending samples to laboratories to be cultured, a process that can take days. Providing immediate results to patients can reduce the spread of infection, improve patients' quality of life and simplify the work of busy clinicians.

The new technology can distinguish strains of the same bacteria that can be treated with antibiotics from others that are resistant to antibiotics, a critical distinction that can help battle the growing problem of antimicrobial resistance, or AMR.

"Clinicians identified testing delays as a problem that needed to be resolved," says Soleymani, who holds the Canada Research Chair in Miniaturized Biomedical Devices. "We wanted to build a system that could give as much information as possible to the physician during the patient's first visit."

The researchers are in the midst of testing an adaptation of the same technology for the virus that causes COVID-19, using samples from a Hamilton clinic.

"This technology is very versatile and we're getting very close to using the same technology for COVID-19 testing," says Li, who is also a member of McMaster's Michael Groote Institute for Infectious Disease Research.

The researchers are exploring regulatory approvals and industry partnerships to get the technology into wide use as quickly as possible, not only in Canada, but around the world, especially where access to lab testing is limited or non-existent.

"I think this technology is a step toward democratizing disease diagnosis and management," says lead author Richa Pandey, a post-doctoral research fellow in Soleymani's lab. "This is technology that can go anywhere in the world where testing is needed."

Transient pacemaker harmlessly dissolves in body

Wireless, fully implantable device gives temporary pacing without requiring removal

Date:June 28, 2021Source:Northwestern UniversitySummary:The thin, flexible, lightweight device could be used in patients who need temporary pacing after cardiac surgery or while waiting for a permanent pacemaker. All components of the pacemaker are biocompatible and naturally absorb into the body's biofluids over the course of five to seven weeks, without needing surgical extraction.

Researchers at Northwestern and George Washington (GW) universities have developed the first-ever transient pacemaker -- a wireless, battery-free, fully implantable pacing device that disappears after it's no longer needed.

The thin, flexible, lightweight device could be used in patients who need temporary pacing after cardiac surgery or while waiting for a permanent pacemaker. All components of the pacemaker are biocompatible and naturally absorb into the body's biofluids over the course of five to seven weeks, without needing surgical extraction.

The device wirelessly harvests energy from an external, remote antenna using near-field communication protocols -- the same technology used in smartphones for electronic payments and in RFID tags. This eliminates the need for bulky batteries and rigid hardware, including wires (or leads). Not only can leads introduce infections, they also can become enveloped in scar tissue, causing further damage when removed.

The study will be published June 28 in the journal Nature Biotechnology. The paper demonstrates the device's efficacy across a series of large and small animal models.

"Hardware placed in or near the heart creates risks for infection and other complications," said Northwestern's John A. Rogers, who led the device's development. "Our wireless, transient pacemakers overcome key disadvantages of traditional temporary devices by eliminating the need for percutaneous leads for surgical extraction procedures -- thereby offering the potential for reduced costs and improved outcomes in patient care. This unusual type of device could represent the future of temporary pacing technology."

"Sometimes patients only need pacemakers temporarily, perhaps after an open heart surgery, heart attack or drug overdose," said Dr. Rishi Arora, a cardiologist at Northwestern Medicine who co-led the study. "After the patient's heart is stabilized, we can remove the pacemaker. The current standard of care involves inserting a wire, which stays in place for three to seven days. These have potential to become infected or dislodged."

"The transient electronics platform opens an entirely new chapter in medicine and biomedical research," said GW's Igor Efimov, who co-led the study with Rogers and Arora. "The bioresorbable materials at the foundation of this technology make it possible to create whole host of diagnostic and therapeutic transient devices for monitoring progression of diseases and therapies, delivering electrical, pharmacological, cell therapies, gene reprogramming and more."

Rogers is the Louis Simpson and Kimberly Querrey Professor of Materials Science and Engineering, Biomedical Engineering and Neurological Surgery in the McCormick School of Engineering and Feinberg School of Medicine and the director of the Querrey Simpson Institute for Bioelectronics. Arora is a professor of medicine at Feinberg and co-director of the Center for Arrhythmia Research. Efimov is the Alisann and Terry Collins Professor of Biomedical Engineering at GW.

Ditching restrictive, risky leads

Currently, to set up a temporary pacing after open heart surgery, surgeons must sew on temporary pacemaker electrodes on the heart muscle during surgery. These have leads that exit the front of a patient's chest, connecting to an external pacing box that delivers a current to control the heart's rhythm.

When the temporary pacemaker is no longer needed, physicians remove the pacemaker electrodes. Although uncommon, potential complications of implanted temporary pacemakers include infection, dislodgement, torn or damaged tissues, bleeding and blood clots.

With Northwestern and GW's transient pacemaker, surgeons and patients can sidestep this potentially risky procedure. The fully implantable device is light and thin -- 250 microns thick and weighing less than half a gram. Soft and flexible, it encapsulates electrodes that softly laminate onto the heart's surface to deliver an electrical pulse.

"Instead of using wires that can get infected and dislodged, we can implant this leadless biocompatible pacemaker," Arora said. "The circuitry is implanted directly on the surface of the heart, and we can activate it remotely. Over a period of weeks, this new type of pacemaker 'dissolves' or degrades on its own, thereby avoiding the need for physical removal of the pacemaker electrodes. This is potentially a major victory for post-operative patients.

"With further modifications, it eventually may be possible to implant such bioresorbable pacemakers through a vein in the leg or arm," he added. "In this instance, it also may be possible to provide temporary pacing to patients who have suffered a heart attack or to patients undergoing catheter-based procedures, such as trans-catheter aortic valve replacement."

Prioritizing patient comfort

Northwestern Medicine cardiac surgeon Dr. Duc Thinh Pham, who was not involved with the research, imagines a transient pacemaker undoubtedly would make his patients more comfortable. With current pacemakers, patients often feel discomfort for days after the leads are inserted. Then, they must limit their movements and activities in order to prevent the leads from dislodging.

"This transient pacemaker is brilliant," said Pham, who has performed more than 2,000 cardiac surgeries throughout his career. "In addition to addressing the primary issue of occasional post-cardiac surgery patients needing temporary pacing due to blockages or arrhythmias, the device addresses the secondary issue of patient comfort, ability to move freely and rehabilitate. If successful, this device will greatly improve a patient's post-operative course."

Disappearing act

This is the second example of bioresorbable electronic medicine from the Rogers lab, which has been studying transient electronics for over a decade. In 2018, Rogers and colleagues demonstrated the world's first bioresorbable electronic device -- a biodegradable implant that speeds nerve regeneration. The team's bioresorbable devices are completely harmless -- similar to absorbable stitches. After fully degrading, the devices completely disappear through the body's natural biological processes.

"There is clearly a need for better temporary cardiac pacemakers," said Dr. Bradley Knight, the Chester C. and Deborah M. Cooley Distinguished Professor of Cardiology at Feinberg and coauthor of the study. "When I first learned about the bioresorbable nerve stimulator, I contacted Professor Rogers to explore the possibility of using this technology to pace the heart. He had already started working with Dr. Efimov to develop a small version of a bioresorbable pacemaker as a proof of concept. We then worked with both teams to develop a larger version of a bioresorbable, leadless, cardiac pacemaker that could be effective on a human scale. It's a great example of what we can create at Northwestern by bridging the expertise in engineering and medicine."

Depending on the patient, a temporary pacemaker might be needed anywhere from a couple days to several weeks. By varying the composition and thickness of the materials in the device, Rogers' team can control the precise number of days it remains functional before dissolving.

"We build these devices out of different types of safe, bioresorbable materials and in optimized architectures to ensure stable operation over a time period somewhat longer than is clinically necessary," Rogers said. "We can tailor the devices to address a broad spectrum of relevant lifetimes. Transient technologies, in general, could someday provide therapy or treatment for a wide variety of medical conditions -- serving, in a sense, as an engineering form of medicine."

Story Source:

Materials provided by Northwestern University. Original written by Amanda Morris. Note: Content may be edited for style and length.

Journal Reference:

• Yeon Sik Choi, Rose T. Yin, Anna Pfenniger, Jahyun Koo, Raudel Avila, K. Benjamin Lee, Sheena W. Chen, Geumbee Lee, Gang Li, Yun Qiao, Alejandro Murillo-Berlioz, Alexi Kiss, Shuling Han, Seung Min Lee, Chenhang Li, Zhaoqian Xie, Yu-Yu Chen, Amy Burrell, Beth Geist, Hyoyoung Jeong, Joohee Kim, Hong-Joon Yoon, Anthony Banks, Seung-Kyun Kang, Zheng Jenny Zhang, Chad R. Haney, Alan Varteres Sahakian, David Johnson, Tatiana Efimova, Yonggang Huang, Gregory D. Trachiotis, Bradley P. Knight, Rishi K. Arora, Igor R. Efimov, John A. Rogers. Fully implantable and bioresorbable cardiac pacemakers without leads or batteries. Nature Biotechnology, 2021; DOI: 10.1038/s41587-021-00948-x

FACE MASKS: TO WEAR OR NOT WEAR?

Prior to Covid-19 pandemic masks were worn to protect open wounds during surgery or wound dressing. They were also worn to protect providers against contagious respiratory infections or toxic fumes or smoke. Such uses of masks will definitely continue in the face of the current pandemic. Social wearing of mask will, however depend on the environment. If the CDC establishes a high viral load in any locality with associated high Covid-19 positive test rate, then that becomes an epicenter that calls for mask wearing to protect both vaccinated and unvaccinated individuals.

In all other low risk external environments mask wearing would only be an option for unvaccinated or low immune individuals who want to protect themselves against infections, dusts, and smoke. But when it comes to enclosed environments where it is not clear who is vaccinated or not, the policies adopted for cigarette smoking to control lung cancer should apply. Some environments are nonsmoking by law, while others are by choice. Same goes for Covid-19 virus. Some enclosed arenas may choose to be covid19-free, allowing only vaccinated individuals to enter inside them. Others may be segregated into covid-19 and non-covid-19 sections, allowing users to decide where they want to be.

Places like restaurants and movie theaters can have signs that say, "Vaccinated" and "Unvaccinated" thereby allowing individuals to choose to risk or not risk exposure to covid-19 virus. While there may not be strict social distancing requirements at this time, individual bubble spaces would still need to be respected in whichever environment one choose to socialize.

COVID-19 vaccines go through many tests for safety and effectiveness and are then monitored closely.

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Dementia increases the risk and severity of COVID-19, study finds

May 5, 2021

February 25, 2021

Chronic ConditionsClinical ResearchCOVID-19DementiasDemographyHealth Care Research

People with dementia have a higher risk of getting COVID-19, are more likely to require hospitalization, and are more likely to have severe or fatal cases of this disease compared with people without dementia. This risk is even higher in Black patients with dementia, according to a new study funded in part by NIA and published in Alzheimer’s & Dementia.

A person’s age and preexisting health conditions such as asthma, diabetes, heart disease, and obesity are significant risk factors for serious illness from COVID-19. Interestingly, these factors are also linked to dementia. However, scientists and doctors have little information about how COVID-19 affects people who have dementia. The new study, led by researchers at Case Western Reserve University, used information from the electronic health records of about 61.9 million U.S. adults from all 50 states to explore the link between dementia and COVID-19. The data was collected as part of the IBM Watson Health Explorys database. In this dataset, more than 1 million patients had dementia, 15,770 had COVID-19, and 810 had both.

The study found that people with dementia were twice as likely to get COVID-19 compared with people without dementia, even after adjusting for age, sex, living in a nursing home, and having similar preexisting conditions. The researchers suggest that the memory problems associated with dementia might make it difficult for patients to stick to safety measures such as wearing masks, washing hands frequently, and social distancing.

Results showed that 73% of Black patients with dementia and 54% of White patients with dementia were hospitalized within 6 months of their COVID-19 diagnosis, compared with 25% of patients without dementia. Only 20% of Black patients with dementia but not COVID-19 and 12% of White patients with dementia but not COVID-19 were hospitalized within the same time frame. Patients of either race with dementia were almost four times more likely to die from COVID-19 than patients without dementia. The researchers also found that vascular dementia, which is caused by damage to the vessels that supply blood to the brain, led to the highest risk of COVID-19, suggesting that damaged blood vessels might make it easier for disease-causing bacteria and viruses to get from a person’s blood into the brain.

Although their findings need to be replicated using other databases and registries, the researchers note that the study lays the foundation for future research into the interactions between COVID-19 and brain diseases, including whether COVID-19’s effects on the brain increase the risk of or worsen dementia. The study demonstrates the need for innovative and effective measures to protect older adults with dementia from COVID-19 as part of controlling the pandemic and highlights the pressing need to address health disparities.

This research was supported in part by NIA grants AG057557 and AG062272.

These activities relate to NIH’s AD+ADRD Research Implementation Milestone 1.H, “Enable access to electronic health records (EHR) data and provide support for their integration with clinical and molecular data to build person-specific predictive models of disease and wellness and to enable disease sub-classification,” and 1.I, “Test early mechanistic pathways of multiple etiologies that may account for AD/ADRD health disparities and scientifically move forward potential opportunities for precision medicine.”

Reference: Wang Q, et al. COVID-19 and dementia: Analyses of risk, disparity, and outcomes from electronic health records in the US. Alzheimer’s & Dementia. 2021, Feb 9. doi: 10.1002/alz.12296. E-published ahead of print.

CDC Real-World Study Confirms Protective Benefits of mRNA COVID-19 Vaccines

Study involved health care personnel, first responders, and essential workers in six states

Press Release

May 4, 2021

Embargoed until: 11 a.m. ET, Monday, March 29, 2021

Contact: Media Relations

(404) 639-3286

A new CDC study provides strong evidence that mRNA COVID-19 vaccines are highly effective in preventing SARS-CoV-2 infections in real-world conditions among health care personnel, first responders, and other essential workers. These groups are more likely than the general population to be exposed to the virus because of their occupations.

The study looked at the effectiveness of Pfizer-BioNTech and Moderna mRNA vaccines in preventing SARS-CoV-2 infections among 3,950 study participants in six states over a 13-week period from December 14, 2020 to March 13, 2021.

Results showed that following the second dose of vaccine (the recommended number of doses), risk of infection was reduced by 90 percent two or more weeks after vaccination. Following a single dose of either vaccine, the participants’ risk of infection with SARS-CoV-2 was reduced by 80 percent two or more weeks after vaccination.

It takes about two weeks following each dose of vaccine for the body to produce antibodies that protect against infection. As a result, people are considered “partially vaccinated” two weeks after their first dose of mRNA vaccine and “fully vaccinated” two weeks after their second dose. These new vaccine effectiveness findings are consistent with those from Phase 3 clinical trials conducted with the vaccines before they received Emergency Use Authorizations from the Food and Drug Administration. Those clinical trials evaluated vaccine efficacy against COVID-19 disease, while this study evaluated vaccine effectiveness against infection, including infections that did not result in symptoms.

“This study shows that our national vaccination efforts are working. The authorized mRNA COVID-19 vaccines provided early, substantial real-world protection against infection for our nation’s health care personnel, first responders, and other frontline essential workers,” said CDC Director Rochelle P. Walensky, MD, MPH. “These findings should offer hope to the millions of Americans receiving COVID-19 vaccines each day and to those who will have the opportunity to roll up their sleeves and get vaccinated in the weeks ahead. The authorized vaccines are the key tool that will help bring an end to this devastating pandemic.”

One of this study’s strengths is its design: participants self-collected nasal swabs each week for RT-PCR laboratory testing, regardless of whether they had developed symptoms of illness. Researchers were able to look for evidence of SARS-CoV-2 infection irrespective of symptoms. A small number (10.7 percent) of infections in this study were asymptomatic (i.e., did not result in symptoms). However, the majority of infections (58 percent) occurred among people whose infections were identified by testing before they developed symptoms or knew they were infected. The study demonstrates that these two mRNA vaccines can reduce the risk of all SARS-CoV-2 infections, not just symptomatic infections.

This is important because preventing both asymptomatic and pre-symptomatic infections among health care workers and other essential workers through vaccination can help prevent the spread of SARS-CoV-2 to those they care for or serve. Findings from this study complement earlier reports that these two mRNA COVID-19 vaccines can reduce both asymptomatic and symptomatic SARS-CoV-2 infections.

This study also provided positive news about partial (one-dose) vaccination. The one-dose VE estimate of this study (80 percent) is consistent with other recent VE studies following the first dose of Pfizer-BioNTech vaccine among health care providers. Studies conducted in the United Kingdom and Israel showed that one dose was about 70 percent and 60 percent effective, respectively, against SARS-CoV-2 infection. The current results provide reassurance that people start to develop protection from the vaccine two weeks after their first dose. The greatest protection was seen among those who had received both recommended doses of the vaccine.

This CDC study was conducted through the HEROES-RECOVER network, a network of prospective cohorts that share a common protocol and methods. This network is part of a vaccine effectiveness surveillance system made possible by federal pandemic flu preparedness funding.

This study is the first of many planned COVID-19 vaccine effectiveness studies CDC is conducting to evaluate the benefits of COVID-19 vaccines in various populations and across different outcomes, such as preventing infections, doctor’s visits, hospitalizations, or deaths. Results from these studies assist the medical and public health experts on the Advisory Committee on Immunization Practices and CDC to make important vaccine policy decisions aimed at saving lives.

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CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

Symptoms of Anxiety or Depressive Disorder and Use of Mental Health Care Among Adults During the COVID-19 Pandemic — United States, August 2020–February 2021

Weekly / April 2, 2021 / 70(13);490–494

On March 26, 2021, this report was posted online as an MMWR Early Release.

Anjel Vahratian, PhD1; Stephen J. Blumberg, PhD1; Emily P. Terlizzi, MPH1; Jeannine S. Schiller, MPH1 (View author affiliations)

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Summary

What is already known about this topic?

Large disease outbreaks have been associated with mental health problems.

What is added by this report?

During August 2020–February 2021, the percentage of adults with recent symptoms of an anxiety or a depressive disorder increased from 36.4% to 41.5%, and the percentage of those reporting an unmet mental health care need increased from 9.2% to 11.7%. Increases were largest among adults aged 18–29 years and those with less than a high school education.

What are the implications for public health practice?

Trends in mental health can be used to evaluate the impact of strategies addressing adult mental health status and care during the pandemic and to guide interventions for disproportionately affected groups.

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The spread of disease and increase in deaths during large outbreaks of transmissible diseases is often associated with fear and grief (1). Social restrictions, limits on operating nonessential businesses, and other measures to reduce pandemic-related mortality and morbidity can lead to isolation and unemployment or underemployment, further increasing the risk for mental health problems (2). To rapidly monitor changes in mental health status and access to care during the COVID-19 pandemic, CDC partnered with the U.S. Census Bureau to conduct the Household Pulse Survey (HPS). This report describes trends in the percentage of adults with symptoms of an anxiety disorder or a depressive disorder and those who sought mental health services. During August 19, 2020–February 1, 2021, the percentage of adults with symptoms of an anxiety or a depressive disorder during the past 7 days increased significantly (from 36.4% to 41.5%), as did the percentage reporting that they needed but did not receive mental health counseling or therapy during the past 4 weeks (from 9.2% to 11.7%). Increases were largest among adults aged 18–29 years and among those with less than a high school education. HPS data can be used in near real time to evaluate the impact of strategies that address mental health status and care of adults during the COVID-19 pandemic and to guide interventions for groups that are disproportionately affected.

HPS is a rapid-response online survey using a probability-based sample design to measure the social and economic impact of the COVID-19 pandemic on U.S. households (3). This experimental data product* was developed by the U.S. Census Bureau in partnership with CDC’s National Center for Health Statistics (NCHS) and several other federal statistical agencies. The sample is drawn from the U.S. Census Bureau’s Master Address File.† E-mail addresses and mobile telephone numbers associated with randomly selected housing units are used to invite participants. Analytic files include self-reported data from one adult aged ≥18 years at each address. Data collection began on April 23, 2020, and is ongoing (phase 1 = April 23–July 21, 2020; phase 2 = August 19–October 26, 2020; phase 3 = October 28, 2020–present, with a break during December 22, 2020–January 5, 2021). HPS response rates averaged 2.9%, 9.3%, and 6.5% during phase 1, phase 2, and phase 3 (through February 1, 2021), respectively.

Questions on mental health symptoms were based on the validated four-item Patient Health Questionnaire (PHQ-4) for depression and anxiety and included how often, during the past 7 days, respondents had been bothered by 1) feeling nervous, anxious, or on edge; 2) not being able to stop or control worrying; 3) having little interest or pleasure in doing things; and 4) feeling down, depressed, or hopeless. Adults who had symptoms that generally occurred more than one half of the days or nearly every day were classified as having symptoms, consistent with published scoring recommendations§ (4). Questions about mental health care use included whether, during the past 4 weeks, respondents had 1) taken prescription medication for their mental health, 2) received counseling or therapy from a mental health professional, or 3) needed but did not receive counseling or therapy from a mental health professional (i.e., had an unmet mental health need).

Because of methodological differences between phases 1 and 2, trend analyses were limited to phases 2 and 3.¶ Estimates** are presented for each 2-week data collection period for August 19, 2020–February 1, 2021 (unweighted sample size = 431,656 for phase 2 and 358,977 for phase 3, total = 790,633). Trends were assessed using joinpoint regression.†† In addition, changes in estimates of symptoms of an anxiety or a depressive disorder and the two mental health care measures were compared between August 19–31, 2020, and January 20–February 1, 2021, according to selected respondent characteristics. SAS-callable SUDAAN (version 11.0; RTI International) was used to conduct these analyses. Estimates were weighted to adjust for nonresponse and number of adults in the household and to match U.S. Census Bureau estimates of the population by age, sex, race/ethnicity, and educational attainment.

During August 19–31, 2020, through December 9–21, 2020, significant increases were observed in the percentages of adults who reported experiencing symptoms of an anxiety disorder (from 31.4% to 36.9%), depressive disorder (from 24.5% to 30.2%), and at least one of these disorders (from 36.4% to 42.4%) (Figure 1). Estimates for all three mental health indicators through January 2021 were similar to those in December 2020.

During August 19–31, 2020, through November 25–December 7, 2020, a significant increase was observed in the percentage of adults who reported taking prescription medication or receiving counseling for their mental health (from 22.4% to 25.0%) (Figure 2). Similarly, during August 19–31, 2020, through December 9–21, 2020, a significant increase was observed in the percentage of adults who reported needing but not receiving counseling or therapy for their mental health (from 9.2% to 12.4%). Estimates through January 2021 were similar to those in December 2020.

During August 19–31, 2020, through January 20–February 1, 2021, symptoms of an anxiety or a depressive disorder increased significantly from 36.4% to 41.5% (Table). Significant increases were observed for all demographic subgroups presented, except adults aged ≥80 years and non-Hispanic adults reporting races other than White, Black, or Asian. The largest increases (8.0 and 7.8 percentage points) were among those aged 18–29 years and those with less than a high school education, respectively. During this time, mental health care treatment increased significantly from 22.4% to 24.8%. Significant increases were observed for adults aged 18–29, 30–39, and 60–69 years; men and women; non-Hispanic White and non-Hispanic Black adults; adults with at least a high school education; and adults who had not experienced symptoms of an anxiety or a depressive disorder during the past 7 days.

Unmet mental health needs also increased significantly from 9.2% to 11.7%. Subgroups with significant increases included adults aged 18–29, 30–39, and 50–59 years; men and women; Hispanic, non-Hispanic White, and non-Hispanic Black adults; adults at all education levels; and adults regardless of whether they experienced symptoms of an anxiety or a depressive disorder or both during the past 7 days. The largest increases in unmet mental health needs (7.2 percentage points and 4.3 percentage points) were among adults aged 18–29 years and those with less than a high school education, respectively. During January 20, 2021–February 1, 2021, 23.8% of persons with symptoms of an anxiety or a depressive disorder had unmet mental health needs, and this percentage increased by 2.8 percentage points from August 2020 to February 2021.

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Discussion

The percentage of adults who had symptoms of an anxiety or a depressive disorder during the past 7 days and those with unmet mental health needs during the past 4 weeks increased significantly from August 2020 to February 2021, with the largest increases among those aged 18–29 years and those with less than a high school education. During January 20, 2021–February 1, 2021, more than two in five adults aged ≥18 years experienced symptoms of an anxiety or a depressive disorder during the past 7 days. One in four adults who experienced these symptoms reported that they needed but did not receive counseling or therapy for their mental health.

These findings are consistent with results from surveys conducted early in the COVID-19 pandemic (March–June 2020) that showed an increased prevalence of mental health symptoms, especially among young adults (5–7). The more recent results indicate an increasing prevalence over time later in 2020, which remained increased in early 2021. The trends in symptoms of an anxiety or a depressive disorder from HPS have been shown to be consistent with trends in the weekly number of reported COVID-19 cases, and it has been theorized that increases in these mental health indicators correspond with pandemic trends (8).

The findings in this report are subject to at least four limitations. First, these data are based on self-report and were not confirmed by health professionals. Questions about mental health symptoms might be predictive of but do not necessarily reflect a clinical diagnosis. In addition, the predictive validity of the scales used in this report have not been confirmed when adapted from a 2-week to a 1-week time frame. Second, HPS did not assess the cause of these symptoms; therefore, a direct association with COVID-19 events could not be determined with certainty. Third, changes in mental health symptoms from the summer to the winter months might reflect symptoms associated with seasonal affective disorder (9). However, data from the 2019 National Health Interview Survey (NHIS),§§ measured using the unmodified PHQ-4, did not demonstrate statistically significant changes from August to December 2019 for symptoms of an anxiety disorder (8.1% to 8.6%); a depressive disorder (7.0% to 6.7%); or an anxiety disorder, a depressive disorder, or both (11.0% to 11.3%) (10). Finally, these estimates are intended to represent all adults aged ≥18 years living in housing units in the United States. However, representativeness might be limited by the indirect exclusion of persons without Internet access and by low response rates. Some households were not eligible to participate because the U.S. Census Bureau was unable to match a mobile telephone number or e-mail address. The sampling weights that were applied to all analyses were likely to have reduced some of the potential bias. Nevertheless, these data might not fully meet the U.S. Census Bureau’s quality standards and as such, the bureau labeled these data as experimental.

Despite these limitations, the survey’s timeliness and relevance are strengths of HPS. The U.S. Census Bureau releases data tables to the public 9 days after the close of each data collection period.¶¶ Simultaneously, NCHS updates online visualizations of trends in key health indicators.***

Several measures have been initiated to address increased mental health risks associated with COVID-19,††† and a previous report outlines additional strategies, including expanded use of telehealth, to address mental health conditions during the pandemic (6). Continued near real-time monitoring of mental health trends by demographic characteristics is critical during the COVID-19 pandemic. These trends might be used to evaluate the impact of strategies that address mental health status and care of adults during the pandemic and to guide interventions for groups that are disproportionately affected.

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Acknowledgments

Sonali Sinha; Anthony Lipphardt.

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Corresponding author: Anjel Vahratian, avahratian@cdc.gov.

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1National Center for Health Statistics, CDC.

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All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

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* U.S. Census Bureau experimental data products are statistical products created using new data sources or previously untested methodologies. The analysis in this report was based on publicly available deidentified data files provided by the U.S. Census Bureau. https://www.census.gov/data/experimental-data-products.htmlexternal icon

† The Master Address File is the U.S. Census Bureau’s official inventory of known living quarters in the United States, maintained to facilitate the decennial census. E-mail addresses, mobile telephone numbers, or both were appended for 81% of addresses. Housing units linked to one or more e-mail addresses or mobile telephone numbers are randomly selected to participate.

§ These items are adapted from the validated PHQ-4 for depression and anxiety, which includes the two-item versions of the Generalized Anxiety Disorder (GAD-2, items 1 and 2) scale and the two-item PHQ (PHQ-2, items 3 and 4). Because phase 1 of HPS was conducted weekly, the recall period for these questions was modified from a 2-week to a 1-week period for this survey. For each survey response, answers were assigned a numerical value: not at all (0), several days (1), more than one half of the days (2), and nearly every day (3). The two responses for anxiety symptoms were summed, and adults who had scale scores of ≥3 were classified as having symptoms of an anxiety disorder. The two responses for depressive symptoms were summed, and adults who had scale scores of ≥3 were classified as having symptoms of a depressive disorder. These two composite indicators were used to create the third composite indicator of symptoms of an anxiety disorder, a depressive disorder, or both. This scoring approach is the same as recommended by the developers of PHQ-2 and GAD-2.

¶ Methodological differences between phase 1 and phase 2 complicate examination of trends across the two phases. These differences include a change in the data collection period from 6 days to 13 days, additional reminders sent to nonrespondents in phase 2, and elimination of a longitudinal component that was present in phase 1. Therefore, trends are only examined for phases 2 and 3. Sample sizes for the mental health questions averaged 86,000 completed surveys biweekly in phase 2 and 60,000 biweekly in phase 3 through February 1, 2021.

** All estimates shown met the NCHS Data Presentation Standards for Proportions (https://www.cdc.gov/nchs/data/series/sr_02/sr02_175.pdfpdf icon).

†† Joinpoint regression characterizes trends as joined linear segments (https://surveillance.cancer.gov/joinpoint/external icon). A joinpoint is the period at which two segments with different slopes meet. Joinpoint software uses statistical criteria to determine the fewest number of segments necessary to characterize a trend and the periods when segments begin and end. The models were specified to include a minimum of one joinpoint.

§§ NHIS is an annual household survey of the noninstitutionalized U.S. civilian population. In 2019, NHIS included the eight-item PHQ (PHQ-8) depression scale and seven-item GAD (GAD-7) scale as part of its sample adult interview.

¶¶ The U.S. Census Bureau releases data files to the public within 4 weeks after the close of each data collection period. https://www.census.gov/programs-surveys/household-pulse-survey/data.htmlexternal icon

*** https://www.cdc.gov/nchs/covid19/health-care-access-and-mental-health.htm

††† https://howrightnow.org/external icon; https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/managing-stress-anxiety.html; https://www.samhsa.gov/find-help/disaster-distress-helplineexternal icon

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References

• Amsalem D, Dixon LB, Neria Y. The coronavirus disease 2019 (COVID-19) outbreak and mental health: current risks and recommended actions. JAMA Psychiatry 2021;78:9–10. https://doi.org/10.1001/jamapsychiatry.2020.1730external icon PMID:32579160external icon

• Berkowitz SA, Basu S. Unemployment insurance, health-related social needs, health care access, and mental health during COVID-19 pandemic. JAMA Intern Med 2020. https://doi.org/10.1001/jamainternmed.2020.7048external icon PMID:33252615external icon

• Fields JF, Hunter-Childs J, Tersine A, et al. Design and operation of the 2020 Household Pulse Survey. Washington, DC: US Census Bureau; 2020. https://www2.census.gov/programs-surveys/demo/technical-documentation/hhp/2020_HPS_Background.pdfpdf iconexternal icon

• Kroenke K, Spitzer RL, Williams JB, et al. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics 2009;50:613–21. PMID:19996233external icon

• McKnight-Eily LR, Okoro CA, Strine TW, et al. Racial and ethnic disparities in the prevalence of stress and worry, mental health conditions, and increased substance use among adults during the COVID-19 pandemic—United States, April and May 2020. MMWR Morb Mortal Wkly Rep 2021;70:162–6. https://doi.org/10.15585/mmwr.mm7005a3external icon PMID:33539336external icon

• Czeisler MÉ, Lane RI, Petrosky E, et al. Mental health, substance use, and suicidal ideation during the COVID-19 pandemic—United States, June 24–30, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1049–57. https://doi.org/10.15585/mmwr.mm6932a1external icon PMID:32790653external icon

• Keeter S. People financially affected by COVID-19 outbreak are experiencing more psychological distress than others. Washington, DC: Pew Research Center; 2020. https://www.pewresearch.org/fact-tank/2020/03/30/people-financially-affected-by-covid-19-outbreak-are-experiencing-more-psychological-distress-than-others/external icon

• Sebenius I. Anxiety and depression are following a remarkably similar curve to COVID-19 cases: survey data shows the mental health strain of the pandemic. Vox. December 15, 2020. https://www.vox.com/22174464/covid-cases-anxiety-depression-mental-healthexternal icon

• Lukmanji A, Williams JVA, Bulloch AGM, et al. Seasonal variation in symptoms of depression: a Canadian population based study. J Affect Disord 2019;255:142–9. https://doi.org/10.1016/j.jad.2019.05.040external icon PMID:31150944external icon

• Terlizzi EP, Schiller JS. Estimates of mental health symptomatology, by month of interview: United States, 2019. Hyattsville, MD: US Department of Health and Human Services, CDC, National Center for Health Statistics; 2021. https://www.cdc.gov/nchs/data/nhis/mental-health-monthly-508.pdfpdf icon

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FIGURE 1. Percentage of adults aged ≥18 years with symptoms of anxiety disorder, depressive disorder, or anxiety or depressive disorder during past 7 days, by data collection period — Household Pulse Survey, United States, August 19, 2020–February 1, 2021*

* Household Pulse Survey data collection included a 1-day break between the conclusion of one data collection period and the start of the next, as well as a 2-week break during December 22, 2020–January 5, 2021.

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FIGURE 2. Percentage of adults aged ≥18 years who took prescription medication for mental health or received counseling or therapy during past 4 weeks and percentage who needed but did not receive counseling or therapy during past 4 weeks, by data collection period — Household Pulse Survey, United States, August 19, 2020–February 1, 2021*

* Household Pulse Survey data collection included a 1-day break between the conclusion of one data collection period and the start of the next, as well as a 2-week break during December 22, 2020–January 5, 2021.

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TABLE. Weighted* percentage of adults aged ≥18 years with symptoms of anxiety or depressive disorder during past 7 days, percentage who took prescription medication for mental health or received counseling or therapy during past 4 weeks, and percentage who needed but did not receive counseling or therapy during past 4 weeks, by selected characteristics — Household Pulse Survey, United States, August 19, 2020–February 1, 2021

Characteristic% (95% CI)Symptoms of anxiety or depressive disorder during past 7 daysTook prescription medication for mental health or received counseling or therapy during past 4 weeksNeeded but did not receive counseling or therapy during past 4 weeksAug 19–31, 2020Jan 20–Feb 1, 2021Aug 19–31, 2020Jan 20–Feb 1, 2021Aug 19–31, 2020Jan 20–Feb 1, 2021Total36.4 (35.9–36.9)41.5 (40.7–42.2)†22.4 (22.0–22.9)24.8 (24.2–25.4)†9.2 (8.8–9.6)11.7 (11.1–12.2)†Age group, yrs18–2949.0 (47.5–50.5)57.0 (54.2–59.8)†23.3 (21.5–25.2)26.9 (24.9–29.0)†15.6 (14.5–16.7)22.8 (20.3–25.4)†30–3942.5 (40.8–44.1)45.9 (44.5–47.3)†23.1 (22.1–24.1)27.1 (25.8–28.4)†12.9 (11.9–13.9)16.1 (14.8–17.5)†40–4937.6 (36.3–39.0)41.1 (38.9–43.2)†23.6 (22.8–24.5)25.0 (23.7–26.3)10.0 (9.3–10.7)11.0 (10.0–11.9)50–5934.9 (33.6–36.3)41.2 (39.8–42.6)†23.9 (22.8–25.1)25.4 (24.0–26.9)7.7 (6.9–8.5)9.5 (8.6–10.4)†60–6929.3 (28.0–30.6)33.4 (31.6–35.4)†21.2 (20.2–22.2)23.3 (22.0–24.6)†5.3 (4.8–5.9)5.4 (4.8–6.0)70–7923.2 (21.6–25.0)26.3 (24.6–28.0)†19.6 (18.1–21.1)19.8 (18.3–21.3)2.9 (2.2–3.6)3.1 (2.4–3.9)≥8019.4 (16.3–22.9)22.5 (18.5–27.0)14.8 (12.0–17.9)17.3 (14.1–21.0)1.4 (0.9–2.0)2.3 (1.3–3.7)SexMale31.8 (30.8–32.8)38.0 (36.9–39.1)†16.3 (15.6–17.1)19.1 (18.1–20.1)†6.8 (6.2–7.3)9.1 (8.3–9.8)†Female40.7 (39.9–41.5)44.8 (43.8–45.8)†28.0 (27.3–28.7)30.0 (29.3–30.7)†11.4 (10.9–11.9)14.1 (13.4–14.8)†Race/EthnicityHispanic or Latino40.2 (38.0–42.3)47.1 (44.7–49.4)†17.2 (15.8–18.6)19.5 (17.3–21.9)9.6 (8.6–10.6)12.8 (10.9–14.9)†White, non-Hispanic35.4 (34.8–35.9)39.8 (38.9–40.7)†25.6 (25.0–26.1)28.1 (27.3–28.8)†9.1 (8.7–9.5)11.7 (11.2–12.1)†Black, non-Hispanic37.7 (35.7–39.8)44.5 (41.6–47.5)†15.6 (14.2–17.1)18.7 (16.7–20.8)†9.3 (8.3–10.3)12.2 (10.4–14.1)†Asian, non-Hispanic30.5 (28.2–32.8)37.4 (33.4–41.5)†11.1 (9.7–12.5)12.9 (10.7–15.4)4.8 (3.9–5.8)5.8 (4.5–7.3)Other/Multiple races, non-Hispanic43.1 (40.2–46.1)44.8 (41.0–48.6)25.0 (22.3–27.9)23.8 (20.9–26.9)14.2 (12.1–16.4)13.8 (11.4–16.5)Education levelLess than high school diploma41.8 (38.4–45.2)49.6 (45.7–53.5)†20.0 (17.3–22.9)20.6 (17.5–24.0)7.0 (5.4–8.8)11.3 (8.8–14.2)†High school diploma or GED certificate36.3 (35.0–37.7)41.1 (39.3–42.9)†20.1 (19.1–21.2)22.2 (20.9–23.4)†7.0 (6.3–7.8)8.7 (7.4–10.2)†Some college or associate’s degree39.4 (38.5–40.3)46.4 (45.2–47.6)†23.5 (22.7–24.4)27.7 (26.8–28.7)†11.2 (10.6–11.9)14.9 (13.9–15.9)†Bachelor’s degree or higher32.4 (31.7–33.0)35.5 (34.7–36.3)†24.0 (23.4–24.6)25.4 (24.6–26.1)†9.7 (9.2–10.1)11.4 (10.9–12.0)†Symptoms of anxiety or depressive disorder during past 7 daysDid not experience symptomsNANA13.9 (13.4–14.4)15.6 (14.9–16.4)†2.4 (2.2–2.7)3.1 (2.8–3.5)†Experienced symptomsNANA37.5 (36.5–38.5)37.7 (36.6–38.8)21.0 (20.2–21.8)23.8 (22.8–24.9)†

Abbreviations: CI = confidence interval; GED = general educational development; NA = not applicable.

* Estimates were weighted to adjust for nonresponse and number of adults in the household and to match U.S. Census Bureau estimates of the population by age, sex, race/ethnicity, and educational attainment.

† Significant difference between percentages at two time points (August 19–31, 2020, versus January 20–February 1, 2021) based on two-sided significance tests at the 0.05 level.

Suggested citation for this article: Vahratian A, Blumberg SJ, Terlizzi EP, Schiller JS. Symptoms of Anxiety or Depressive Disorder and Use of Mental Health Care Among Adults During the COVID-19 Pandemic — United States, August 2020–February 2021. MMWR Morb Mortal Wkly Rep 2021;70:490–494. DOI: http://dx.doi.org/10.15585/mmwr.mm7013e2external icon.

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THE FUTURE OF COVID-19 DISEASE

Otumdi Omekara, MD, MPAHA

www.health-pub.com

March 24, 2021

After a full year of Covid-19 pandemic and all that we now know about it from medical research, it is now time to begin to look at its future and how we are going to have to live with it. Influenza Disease or FLU was equally a pandemic from 1918 - 1919, but today it is referred to as common cold because of how almost inconsequential its attack has become, even with seasonal outbreaks and yearly emergence of many new variants. It took almost one century for influenza disease to go from being a pandemic killer to common cold. This suggests that we may have a long road ahead with Covid-19 disease. That being the case, we may need to begin to make projections on its impact on our lives and livelihood and how best to make compensatory adjustments. Our global socio-economics can not be put on hold for a whole century. Just one year interruption of our global commerce and industry has almost led a global recession, with many nations currently struggling to restart their economy.

Covid-19 disease is here to stay, but as time goes on medical research is going to arm us sufficiently to render it almost harmless Right now we know enough to beep up everyone’s immune system with Covid-19 vaccines. Every nation is working hard to provide all her citizens the opportunity to get vaccinated. This might take another year before individual nations achieve herd immunity and global herd immunity is also established. Intra-national and international free travel can then resume. Vaccinated people who get attacked will only have mild sniffles that blow over in less than a week. As new Covid-19 strains emerge adjustments will be made in the mRNA vaccines to include their genetic codes for denovo synthesis of their immune proteins. Vaccinated Covid-19 carriers can only spread attenuated viruses capable of successfully attacking only the unvaccinated individuals. Anti-vaccine individuals who elect not to get vaccinated will take full responsibility for making themselves vulnerable to Covid-19 attack.They will, unfortunately, also form easy breeding grounds for the formation of new Covid-19 strains.

Basic hand washing and covering of cough with the elbows will remain for general hygiene purposes. Social distancing, the way we know it, will soon end as friends and family members begin to hug again. But actively coughing and blood spitting individuals will continue to be avoided or approached with masks in hospital settings. Recovery from Covid-19 disease has been reported to be slow and incomplete by some of the first set of patients hospitalized back in March 2020. Some still struggle with chronic respiratory problems, while others are experiencing chronic complications involving pre-existing conditions in other organs. Specialized Covid-19 clinics are springing up in some big hospitals. Medical curricula are being adjusted to include adequate training credits in Covid-19 disease. Medical textbooks are equally getting updated to include chapters on Covid-19 disease. The years 2020 - 2021 will go down like 1918 -1919 as turning points in world history.

Coronavirus disease (COVID-19): Similarities and differences with influenza

17 March 2020 | Q&A

As the COVID-19 outbreak continues to evolve, comparisons have been drawn to influenza. Both cause respiratory disease, yet there are important differences between the two viruses and how they spread. This has important implications for the public health measures that can be implemented to respond to each virus.

How are COVID-19 and influenza viruses similar?

Firstly, COVID-19 and influenza viruses have a similar disease presentation. That is, they both cause respiratory disease, which presents as a wide range of illness from asymptomatic or mild through to severe disease and death.

Secondly, both viruses are transmitted by contact, droplets and fomites. As a result, the same public health measures, such as hand hygiene and good respiratory etiquette (coughing into your elbow or into a tissue and immediately disposing of the tissue), are important actions all can take to prevent infection.

How are COVID-19 and influenza viruses different?

The speed of transmission is an important point of difference between the two viruses. Influenza has a shorter median incubation period (the time from infection to appearance of symptoms) and a shorter serial interval (the time between successive cases) than COVID-19 virus. The serial interval for COVID-19 virus is estimated to be 5-6 days, while for influenza virus, the serial interval is 3 days. This means that influenza can spread faster than COVID-19.

Further, transmission in the first 3-5 days of illness, or potentially pre-symptomatic transmission –transmission of the virus before the appearance of symptoms – is a major driver of transmission for influenza. In contrast, while we are learning that there are people who can shed COVID-19 virus 24-48 hours prior to symptom onset, at present, this does not appear to be a major driver of transmission.

The reproductive number – the number of secondary infections generated from one infected individual – is understood to be between 2 and 2.5 for COVID-19 virus, higher than for influenza. However, estimates for both COVID-19 and influenza viruses are very context and time-specific, making direct comparisons more difficult.

Children are important drivers of influenza virus transmission in the community. For COVID-19 virus, initial data indicates that children are less affected than adults and that clinical attack rates in the 0-19 age group are low. Further preliminary data from household transmission studies in China suggest that children are infected from adults, rather than vice versa.

While the range of symptoms for the two viruses is similar, the fraction with severe disease appears to be different. For COVID-19, data to date suggest that 80% of infections are mild or asymptomatic, 15% are severe infection, requiring oxygen and 5% are critical infections, requiring ventilation. These fractions of severe and critical infection would be higher than what is observed for influenza infection.

Those most at risk for severe influenza infection are children, pregnant women, elderly, those with underlying chronic medical conditions and those who are immunosuppressed. For COVID-19, our current understanding is that older age and underlying conditions increase the risk for severe infection.

Mortality for COVID-19 appears higher than for influenza, especially seasonal influenza. While the true mortality of COVID-19 will take some time to fully understand, the data we have so far indicate that the crude mortality ratio (the number of reported deaths divided by the reported cases) is between 3-4%, the infection mortality rate (the number of reported deaths divided by the number of infections) will be lower. For seasonal influenza, mortality is usually well below 0.1%. However, mortality is to a large extent determined by access to and quality of health care.

What medical interventions are available for COVID-19 and influenza viruses?

While there are a number of therapeutics currently in clinical trials in China and more than 20 vaccines in development for COVID-19, there are currently no licensed vaccines or therapeutics for COVID-19. In contrast, antivirals and vaccines available for influenza. While the influenza vaccine is not effective against COVID-19 virus, it is highly recommended to get vaccinated each year to prevent influenza infection.

FACE MASKS: TO WEAR OR NOT WEAR?

Otumdi Omekara, MD, MPAHA

www.health-pub.com

April 15, 2021 - Portland Oregon

Prior to Covid-19 pandemic masks were worn to protect open wounds during surgery or wound dressing. They were also worn to protect providers against contagious respiratory infections or toxic fumes or smoke. Such uses of masks will definitely continue in the face of the current pandemic. Social wearing of mask will, however depend on the environment. If the CDC establishes a high viral load in any locality with associated high Covid-19 positive test rate, then that becomes an epicenter that calls for mask wearing to protect both vaccinated and unvaccinated individuals.

In all other low risk external environments mask wearing would only be an option for unvaccinated or low immune individuals who want to protect themselves against infections, dusts, and smoke. But when it comes to enclosed environments where it is not clear who is vaccinated or not, the policies adopted for cigarette smoking to control lung cancer should apply. Some environments are nonsmoking by law, while others are by choice. Same goes for Covid-19 virus. Some enclosed arenas may choose to be covid19-free, allowing only vaccinated individuals to enter inside them. Others may be segregated into covid-19 and non-covid-19 sections, allowing users to decide where they want to be.

Places like restaurants and movie theaters can have signs that say, "Vaccinated" and "Unvaccinated" thereby allowing individuals to choose to risk or not risk exposure to covid-19 virus. While there may not be strict social distancing requirements at this time, individual bubble spaces would still need to be respected in whichever environment one choose to socialize.

COVID-19 vaccines go through many tests for safety and effectiveness and are then monitored closely.

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Johnson & Johnson Vaccine: How should we understand the pause?

New York Times, April 14, 2021

On Tuesday, federal hea lth agencies in the United States called for a temporary halt in the use of Johnson & Johnson’s Covid-19 vaccine over concerns that the vaccine may be linked to a rare disorder involving blood clots.

Six vaccine recipients — all women between the ages of 18 and 48 — developed the disorder within about two weeks of vaccination. One woman died and a second woman has been hospitalized in critical condition.

Nearly every state, as well as CVS and Walgreens, have halted use of the shot.

The following is a preview of our Coronavirus Briefing newsletter, an informed guide to the pandemic. Sign up here to get this newsletter in your inbox.

Nearly seven million people in the United States have received Johnson & Johnson shots so far.Mary Altaffer/Associated Press

Carl Zimmer, a New York Times science reporter, answers questions about where things stand.

What is the link between the vaccines and the blood clots?

It’s not clear how much the Johnson & Johnson vaccine is involved in these cases — if at all. The reason that the federal agencies are recommending a pause is that all six of these people got a particular kind of blood clot, and that’s unusual. But you have to bear in mind that every day, thousands of people get blood clots for lots of different reasons. So they have to do more research to figure out if the vaccines are actually causing these very rare blood clots. And if so, why is it that only six people that we know of out of almost seven million people got it?

In the world of vaccines, are figures like that — six out of seven million — unusual?

It’s just too soon to say that this vaccine raises your risk, even slightly, of blood clots. If there is a risk, it’s so incredibly small it’s almost impossible for us to imagine. To give you a little context, the risk of getting struck by lightning in a given year is one in 500,000. So people should be careful about getting hit by lightning, but we don’t go outside thinking, “Today is the day I’m going to die of lightning strikes.”

How should we understand the pause?

The Food and Drug Administration explained today that they are pausing this vaccine out of an abundance of caution so that they can spend some time understanding what is going on. And they foresee that it won’t take more than a few days to finish the investigation.

That said, people don’t normally pay really, really close attention to vaccine trials and vaccine rollout. But right now the whole world is paying very close attention to these vaccines. So the idea of a pause might seem alarming and unprecedented, but in fact, pauses happen all the time, both in trials and in rollouts of medical products.

What should people who have gotten the Johnson & Johnson vaccine do?

They should bear in mind that we don’t know yet if the vaccines are associated with this rare clot. If they are associated with the clot, the odds are incredibly small that they will experience it.

And there are things you can do to be careful. Two or three weeks after the vaccine, if you start experiencing severe headaches or leg pains, you should let your doctor know right away. Or go to the E.R. if you’re really feeling terrible and let them know that you’ve gotten the shot. But you don’t need to worry about having a headache and flulike symptoms in the first few days after getting the shot. Lots of people get that — it’s really common and it’s completely harmless.

More on Johnson & Johnson:

• The pharmaceutical company said it would delay the rollout of its vaccine in Europe.

• Jeffrey Zients, the White House Covid-19 response coordinator, said the pause “will not have a significant impact” on the nation’s vaccination program, as the country already has enough vaccines from Pfizer and Moderna to inoculate almost all American adults.

• What is a blood clot? Does this risk mainly affect women? Science reporters at The Times answered common questions on blood clots and vaccines.

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CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns

By Jacqueline Howard, CNN

Updated 3:40 PM ET, Tue April 13, 2021

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Dr. Gupta: Johnson & Johnson vaccine pause will fuel hesitancy

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'Michigan needs to be shut down': Doctor on Covid-19 surge

Michigan sees alarming uptick in Covid-19 cases

Buttigieg to evangelicals: 'Maybe a vaccine is part of God's plan'

Dr. Sanjay Gupta looks into the origins of vaccine hesitancy

CDC: Children's team sports likely cause for spread

Covid-19 long hauler describes relief after getting vaccine

EU agency finds AstraZeneca vaccine can cause rare blood clots

UK variant now most dominant strain in US

CDC director: UK variant is now dominant Covid-19 strain in US

Hear doctor's message for people with J&J vaccine concerns

Dr. Gupta: Johnson & Johnson vaccine pause will fuel hesitancy

WHO official: We are at a 'critical point' of the pandemic

Fauci talks about what he is comfortable doing now that he's fully vaccinated

Half of US adults expected to have at least 1 vaccine dose by next week

Health advocates go door-to-door to fight vaccine hesitancy

'Michigan needs to be shut down': Doctor on Covid-19 surge

Michigan sees alarming uptick in Covid-19 cases

(CNN)The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson's Covid-19 vaccine over six reported US cases of a "rare and severe" type of blood clot. One of the cases was fatal and one is currently in critical condition.

The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.

Federal official: CDC, FDA taking reports of blood clots and J&J Covid-19 vaccine 'seriously'

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

"CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance," the statement said. "FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."

'It's a very rare event'

Johnson & Johnson issued a statement on Tuesday noting that the company has decided to "proactively delay the rollout" of its vaccine in Europe.

"We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public," the statement said in part.

Half of US adults expected to have at least 1 vaccine dose by next week 02:43

For people who have received the Johnson & Johnson shot, those who have developed severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider, according to the statement.

The statement also noted that these adverse events "appear to be extremely rare."

"It's a very rare event. You're talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn't see in the clinical trial just because you didn't have millions of people enrolled," Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System, told CNN's John Berman and Poppy Harlow on Tuesday morning.

"But I want to congratulate the CDC and the FDA for very quickly jumping on it, halting the vaccinations until we know more, and really trying to understand what's going on," del Rio said. "I think vaccine safety has always been a priority -- and I think this is exactly the right move until we understand what's going on and what's the way forward."

Del Rio added that the blood clotting may be connected to how the Johnson & Johnson vaccine is an adenovirus vector vaccine -- the same type as AstraZeneca's coronavirus vaccine.

Hear doctor's message for people with J&J vaccine concerns 03:06

The AstraZeneca vaccine isn't in use in the United States, but has been authorized in more than 70 countries. The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as "very rare side effects" of the AstraZeneca vaccine. While advising the public to look out for the signs of clots, the regulators said the benefits of the shot were still worth the risk.

"The adenovirus vector vaccine may have something to do with it," del Rio said. The two other Covid-19 vaccines authorized for emergency use in the United States -- Pfizer's and Moderna's -- are mRNA vaccines, which are a different type.

He added that he still recommends people to get vaccinated against Covid-19.

Overall, there appears to be similarities between the rare blood clotting events possibly associated with Johnson & Johnson's coronavirus vaccine and the AstraZeneca coronavirus vaccine, FDA's Marks said during a virtual briefing on Tuesday.

"It's plainly obvious to us already that what we're seeing with the Janssen vaccines looks very similar to what was being seen with the AstraZeneca vaccine," Marks said. Janssen is the vaccine arm of Johnson & Johnson.

"The AstraZeneca is a chimpanzee adenoviral vector vaccine. The Janssen is a human adenoviral vector vaccine," Marks said. "We can't make some broad statement yet, but obviously they are from the same general class of viral vectors."

The mechanism behind the blood clotting events among those who have received the Johnson & Johnson vaccine remains unknown -- but may be similar to the mechanism behind possible events connected to the AstraZeneca vaccine, Marks said.

"We don't have a definitive cause, but the probable cause that we believe may be involved here -- that we can speculate -- is a similar mechanism that may be going on with the other adenoviral vector vaccine," Marks said. "That is that this is an immune response that occurs very, very rarely after some people receive the vaccine and that immune response leads to activation of the platelets and these extremely rare blood clots."

Federal health channels to stop using J&J vaccine immediately

The new announcement from the FDA and CDC means all federal health channels -- mass vaccination sites, community health centers and the like -- that were previously administering the Johnson & Johnson vaccine will immediately stop for the time being, according to a federal health official.

The agencies are recommending that states do the same, but it will be up to the individual states to make that decision because they are given a separate allocation of doses.

The pause happened because this type of blood clot is not listed on the list of potential adverse side effects that were part of the emergency use authorization for J&J.

While officials are stressing it is rare, they want health care providers to have time to understand what potential side effects are and how to best treat them.

The CDC and FDA came to a decision late last night, a federal health official said.

Dr. Gupta: Johnson & Johnson vaccine pause will fuel hesitancy 01:06

The agencies made the recommendation to pause the use of the Johnson & Johnson coronavirus vaccine quickly -- even without giving states a heads up -- because of concern that rare blood clot incidents might be treated inappropriately.

"The issue here with these types of blood clots is that if one administers the standard treatment that we as doctors have learned to give for blood clots, one can cause tremendous harm," Marks said in Tuesday's briefing.

The rare type of blood clots observed in association with the vaccine require unique treatment. For instance, the anticoagulant drug heparin should not be used to treat these types of blood clots, Marks said, adding that health care providers had to be made aware of the pause immediately in case they see patients with possible blood clot symptoms.

"Treatment for this specific type of blood clot is different from typical treatments for other types of blood clots, which usually involve an anticoagulant called heparin," he said. "With cerebral venous sinus thrombosis, heparin may be dangerous and alternative treatments need to be given, preferably under the guidance of physicians experienced in the treatment of blood clots."

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FDA Acting Commissioner Dr. Janet Woodcock said during the briefing that she expects the pause of the Johnson & Johnson vaccine to be "a matter of days."

"As we learned about the issue with appropriate treatment, it was clear to us that we needed to alert the public," Woodcock said.

"The timeframe will depend obviously on what we learn in the next few days," Woodcock said. "However, we expect it to be a matter of days for this pause."

CNN's Elizabeth Cohen, Kaitlan Collins and Ashley Ahn contributed to this report.

Psychologists analyze links between provider burnout, quality of care, patient safety

Date:December 15, 2016Source:Indiana University-Purdue University Indianapolis School of Science, Summary: Psychologists conducted a meta-analysis of 82 studies in the first study to systematically, quantitatively analyze the links between health care provider burnout and health care quality and safety across medical disciplines.

FULL STORY

Health care provider burnout is known to have a relationship with both quality of care and patient safety. Psychologists from the School of Science at Indiana University-Purdue University Indianapolis conducted the first study to systematically, quantitatively analyze the links between health care provider burnout and health care quality and safety across medical disciplines.

The meta-analysis of 82 studies focused on links between burnout and quality as well as between burnout and safety. The studies involved almost 211,000 physicians, nurses and other clinicians.

The IUPUI scientists examined relationships between various aspects of provider burnout -- including emotional exhaustion, depersonalization and reduced personal accomplishment -- and the quality of care as perceived by providers and as perceived by patients (patient satisfaction). The scientists also examined the link between provider burnout and health care safety in the studies.

Provider self-reported quality ratings had a stronger correlation with burnout than did patient satisfaction. Similarly for safety concerns, provider burnout had a stronger relationship with perceptions of safety than with reported safety events including close or near misses; however, both relationships were still statistically significant.

"The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis" is published online ahead of print in the Journal of General Internal Medicine.

In their meta-analysis, the IUPUI scientists combined data from different types of studies conducted at numerous locations around the world with a variety of types of clinicians. Meta-analysis enables compression of large amounts of information, permitting analysis and dissemination of composite findings.

"We found a consistent relationship -- technically a medium effect size -- between higher levels of provider burnout and lower levels of both quality and safety," said study corresponding author Michelle Salyers, professor of psychology at IUPUI. She directs the school's clinical psychology program and is director of the Assertive Community Treatment Center of Indiana.

"These are important observations; however, we don't know the direction of the correlations," she said. "Does burnout cause care quality to diminish, or does poor quality cause clinician burnout? Or is there another factor causing both provider burnout and poor quality?"

Studies were weighted to account for the number of providers involved. The IUPUI scientists also rated the rigor of the studies to determine if the correlation between burnout and quality or between burnout and safety varied by study size and thoroughness of investigation. They found that it did not. They did, however, note roles for other predictors of quality and safety including organizational policies, staffing ratios and communication.

"While burnout is not the primary cause of poor quality health care nor the primary cause of patient safety issues, links between provider burnout and care quality and patient safety are real and should be recognized," said Salyers. "Our work provides a message for health care funders, policymakers and those who 'run' health care in a variety of settings -- clinic, hospital and system administrators -- that as they work to improve patient outcomes and safety, they should pay attention to the well-being of their workforce."

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Story Source:

Materials provided by Indiana University-Purdue University Indianapolis School of Science. Note: Content may be edited for style and length.

Journal Reference:

• Michelle P. Salyers, Kelsey A. Bonfils, Lauren Luther, Ruth L. Firmin, Dominique A. White, Erin L. Adams, Angela L. Rollins. The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis. Journal of General Internal Medicine, 2016; DOI: 10.1007/s11606-016-3886-9

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Indiana University-Purdue University Indianapolis School of Science. "Psychologists analyze links between provider burnout, quality of care, patient safety." ScienceDaily. ScienceDaily, 15 December 2016. <www.sciencedaily.com/releases/2016/12/161215085942.htm>

The (robotic) doctor will see you now

Study finds patients are receptive to interacting with robots designed to evaluate symptoms in a contact-free way

Date:March 4, 2021Source:Massachusetts Institute of TechnologySummary:A large majority of patients interacting with a health care provider via a video screen mounted on a robot said it was similar to an in-person interaction with a health care worker.Share:

FULL STORY

In the era of social distancing, using robots for some health care interactions is a promising way to reduce in-person contact between health care workers and sick patients. However, a key question that needs to be answered is how patients will react to a robot entering the exam room.

Researchers from MIT and Brigham and Women's Hospital recently set out to answer that question. In a study performed in the emergency department at Brigham and Women's, the team found that a large majority of patients reported that interacting with a health care provider via a video screen mounted on a robot was similar to an in-person interaction with a health care worker.

"We're actively working on robots that can help provide care to maximize the safety of both the patient and the health care workforce. The results of this study give us some confidence that people are ready and willing to engage with us on those fronts," says Giovanni Traverso, an MIT assistant professor of mechanical engineering, a gastroenterologist at Brigham and Women's Hospital, and the senior author of the study.

In a larger online survey conducted nationwide, the researchers also found that a majority of respondents were open to having robots not only assist with patient triage but also perform minor procedures such as taking a nose swab.

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Peter Chai, an assistant professor of emergency medicine at Brigham and Women's Hospital and a research affiliate in Traverso's lab, is the lead author of the study, which appears today in JAMA Network Open.

Triage by robot

After the Covid-19 pandemic began early last year, Traverso and his colleagues turned their attention toward new strategies to minimize interactions between potentially sick patients and health care workers. To that end, they worked with Boston Dynamics to create a mobile robot that could interact with patients as they waited in the emergency department. The robots were equipped with sensors that allow them to measure vital signs, including skin temperature, breathing rate, pulse rate, and blood oxygen saturation. The robots also carried an iPad that allowed for remote video communication with a health care provider.

This kind of robot could reduce health care workers' risk of exposure to Covid-19 and help to conserve the personal protective equipment that is needed for each interaction. However, the question still remained whether patients would be receptive to this type of interaction.

"Often as engineers, we think about different solutions, but sometimes they may not be adopted because people are not fully accepting of them," Traverso says. "So, in this study we were trying to tease that out and understand if the population is receptive to a solution like this one."

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The researchers first conducted a nationwide survey of about 1,000 people, working with a market research company called YouGov. They asked questions regarding the acceptability of robots in health care, including whether people would be comfortable with robots performing not only triage but also other tasks such as performing nasal swabs, inserting a catheter, or turning a patient over in bed. On average, the respondents stated that they were open to these types of interactions.

The researchers then tested one of their robots in the emergency department at Brigham and Women's Hospital last spring, when Covid-19 cases were surging in Massachusetts. Fifty-one patients were approached in the waiting room or a triage tent and asked if they would be willing to participate in the study, and 41 agreed. These patients were interviewed about their symptoms via video connection, using an iPad carried by a quadruped, dog-like robot developed by Boston Dynamics. More than 90 percent of the participants reported that they were satisfied with the robotic system.

"For the purposes of gathering quick triage information, the patients found the experience to be similar to what they would have experienced talking to a person," Chai says.

Robotic assistants

The numbers from the study suggest that it could be worthwhile to try to develop robots that can perform procedures that currently require a lot of human effort, such as turning a patient over in bed, the researchers say. Turning Covid-19 patients onto their stomachs, also known as "proning," has been shown to boost their blood oxygen levels and make breathing easier. Currently the process requires several people to perform. Administering Covid-19 tests is another task that requires a lot of time and effort from health care workers, who could be deployed for other tasks if robots could help perform swabs.

"Surprisingly, people were pretty accepting of the idea of having a robot do a nasal swab, which suggests that potential engineering efforts could go into thinking about building some of these systems," Chai says.

The MIT team is continuing to develop sensors that can obtain vital sign data from patients remotely, and they are working on integrating these systems into smaller robots that could operate in a variety of environments, such as field hospitals or ambulances.

Other authors of the paper include Farah Dadabhoy, Hen-wei Huang, Jacqueline Chu, Annie Feng, Hien Le, Joy Collins, Marco da Silva, Marc Raibert, Chin Hur, and Edward Boyer. The research was funded by the National Institutes of Health, the Hans and Mavis Lopater Psychosocial Foundation, e-ink corporation, the Karl Van Tassel (1925) Career Development Professorship, MIT's Department of Mechanical Engineering, and the Brigham and Women's Hospital Division of Gastroenterology.

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Story Source:

Materials provided by Massachusetts Institute of Technology. Original written by Anne Trafton. Note: Content may be edited for style and length.

Journal Reference:

• Peter R. Chai, Farah Z. Dadabhoy, Hen-Wei Huang, Jacqueline N. Chu, Annie Feng, Hien M. Le, Joy Collins, Marco da Silva, Marc Raibert, Chin Hur, Edward W. Boyer, Giovanni Traverso. Assessment of the Acceptability and Feasibility of Using Mobile Robotic Systems for Patient Evaluation. JAMA Network Open, 2021; 4 (3): e210667 DOI: 10.1001/jamanetworkopen.2021.0667

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Massachusetts Institute of Technology. "The (robotic) doctor will see you now: Study finds patients are receptive to interacting with robots designed to evaluate symptoms in a contact-free way." ScienceDaily. ScienceDaily, 4 March 2021. <www.sciencedaily.com/releases/2021/03/210304112456.htm>

Critical care health care professionals have high rates of burnout syndrome

Date:July 7, 2016Source:American College of Chest PhysiciansSummary:A new report on burnout syndrome in critical care health care professionals gives key stakeholders guidance on mitigating the development of burnout syndrome and calls for initiating research to examine ways to prevent as well as treat burnout syndrome.Share:

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A new report on burnout syndrome in critical care health care professionals gives key stakeholders guidance on mitigating the development of burnout syndrome and calls for initiating research to examine ways to prevent as well as treat burnout syndrome.

The report was published by the Critical Care Societies Collaborative (CCSC), a group consisting of four professional and scientific societies, whose members care for America's critically ill and injured, and aims to raise awareness about burnout syndrome in critical care medicine.

Burnout Syndrome Defined

Burnout syndrome is a state of emotional, mental and physical exhaustion caused by excessive and prolonged stress. This exhaustion is typically work-related and is triggered by discrepancies between the expectations and the actual requirements of the job. Burnout syndrome has become a common worldwide phenomenon, especially among members of high-stress professions, such as firefighters, police officers, teachers and all types of health-care professionals.

Critical care health care professionals have one of the highest rates of burnout syndrome, with nearly half of the workforce exhibiting symptoms.

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Burnout in Critical Care -- A Critical Situation The co-published document reports:

• Up to 45 percent of critical care physicians reported symptoms of severe burnout syndrome, while those specializing in pediatric critical care were at 71 percent.

• Approximately 25 to 33 percent of critical care nurses manifest symptoms of severe burnout syndrome, and up to 86 percent have at least one of the three classic symptoms.

• The high burnout syndrome rate in critical care professionals can be attributed to the especially stressful environment in the ICU due to high patient morbidity and mortality, challenging daily work routines, and regular encounters with traumatic and ethical issues.

• Burnout syndrome in critical care health care professionals may result in posttraumatic stress disorder, alcohol abuse and even suicidal thoughts.

• In nurses, burnout is associated with reduced quality of care, lower patient satisfaction, increased number of medical errors, higher rates of health care associated infections, and higher 30-day patient mortality rates.

Next Steps: Exploring Solutions and Research

"Everyone has a part to play in decreasing burnout syndrome. A full collaborative effort is required among researchers, educators, professional societies, patient advocacy groups, funding agencies, policy makers and ourselves as critical care health care professionals" says Dr. Marc Moss, co-author, vice chair

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of Clinical Research for the Department of Medicine at the University of Colorado School of Medicine, and president-elect of the American Thoracic Society. "We can't take care of patients if we don't take care of each other. An increased commitment to research on burnout syndrome is a necessary first step."

The CCSC call to action advises key stakeholder groups to help mitigate the development of burnout syndrome. Key stakeholders include critical care clinicians, friends and family, ICU unit-based leaders, hospital administrators, funding agencies, professional societies, academic institutions, patient advocacy groups and policy ma