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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- December 21, 2021: COVID-19 Update including a new project in which FDA and its global partners will use machine learning approaches to enhance the understanding of nonclinical model responses to SARS-CoV-2
- December 21, 2021: Looking Ahead to 2022 as FDA’s Center for Devices and Radiological Health (CDRH) Manages a Sustained Increase in Workload, by Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH
- December 20, 2021: Fulfilling Essential Public Health Needs in 2022, by Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
- December 17, 2021: COVID-19 Update including approval of an abbreviated new drug application for a drug indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines (a class of neurotransmitters)
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
Q: Am I currently eligible for a COVID-19 vaccine booster dose, and if so, which one?
A: Everyone ages 16 and older can get a booster shot.
The FDA amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose for people ages 16 and 17 after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.
The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) are the only COVID-19 vaccines currently available for people ages 16 and 17. Individuals ages 16 and 17 should only receive the Pfizer-BioNTech Vaccine or Comirnaty as their booster dose.
If you are 18 or older and received the Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine or Comirnaty (COVID-19 Vaccine, mRNA) for your primary vaccination series at least 6 months ago, then you may receive a booster dose of any of the currently available COVID-19 vaccines. They are:
If you are 18 or older and received the Janssen (J&J) COVID-19 Vaccine as your primary vaccination at least 2 months ago, then you may receive a booster dose of any of the currently available COVID-19 vaccines.
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 and older, when prepared according to their respective instructions for use, can be used interchangeably without any safety or effectiveness concerns.
Manufacturing change for Comirnaty
On December 16, 2021, FDA approved a manufacturing change for Comirnaty (COVID-19 Vaccine, mRNA) to include a formulation that uses a different buffer. Buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers.
This formulation of Comirnaty does not need to be diluted before use, thus, vaccination providers can more readily prepare and deliver appropriate doses. The new formulation contains Tris buffer, a commonly used buffer in other FDA-approved vaccines and biologics.
FDA previously authorized this vaccine formulation for the Pfizer-BioNTech COVID-19 Vaccine in October. The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.
MCMi regulatory science update
Strengthening coronavirus models with systems biology and machine learning
In a new project funded by FDA's Medical Countermeasures Initiatve (MCMi), Australia’s national science agency CSIRO (Commonwealth Scientific and Industrial Research Organisation) and its global partners will use systems biology and machine learning approaches to enhance the understanding of nonclinical model responses to SARS-CoV-2. This project aims to develop the underpinning regulatory science needed to help FDA evaluate nonclinical model data for assessing potential vaccines and therapeutics for COVID-19, including the impact of omicron, and future SARS-CoV-2 variants of concern. (December 21, 2021)
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Emergency Use Authorization (EUA) updates
Pfizer-BioNTech COVID-19 Vaccine shelf life extension
On December 16, 2021, FDA reissued the EUA (PDF) for the authorized Pfizer-BioNTech COVID-19 Vaccine, including an update on expiration dating. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine that uses the Tris buffer (vials with gray caps and labels with gray borders) from 6 months to 9 months when held at -90 °C to -60 °C; revising the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) to include information on the updated expiration dating of the formulation of the Pfizer-BioNTech COVID-19 Vaccine that uses the Tris buffer; and updating the Fact Sheet for Recipients and Caregivers to provide information on the formulation of COMIRNATY (COVID-19 Vaccine, mRNA) that uses the Tris buffer. For additional information, including storage and handling, please see the Tris formulation Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF, 1 MB).
Shelf-life extension of bamlanivimab and etesevimab under the EUA for bamlanivimab and etesevimab administered together
FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together. This announcement provides a cumulative listing of all batches authorized for shelf-life extension, including batches previously authorized for shelf-life extension for bamlanivimab on August 20, 2021 and for etesevimab on October 22, 2021. As a result of this extension, unopened vials of bamlanivimab and etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 and Table 2 here). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the Letter of Authorization (PDF for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together. (December 21, 2021)
EUA revocations
On December 17, 2021, FDA revoked EUAs for 3 tests that are no longer being used:
- SARS-COV-2 R-GENE (BioMérieux SA)
- Atellica IM SARS-CoV-2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
- ADVIA Centaur SARS-CoV-2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information.
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
In vitro diagnostic (test) EUAs
As of December 21, 2021, 418 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 41 antigen tests. There are 67 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 22 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 738 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Information for industry and health care providers
Possible false RPR reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit following a COVID-19 vaccine
FDA issued a letter to clinical laboratory staff and health care providers about false reactivity, or "false-positive," Rapid Plasma Reagin (RPR; non-treponemal) test results when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit in some people who received a COVID-19 vaccine. (December 17, 2021)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
It's a good time to get your flu vaccine Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.
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Why you should not use ivermectin to treat or prevent COVID-19 Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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