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Coronavirus Disease 2019 (COVID-19) updates
Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- September 17, 2021: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers
- September 17, 2021: COVID-19 Update including a revised guidance to help expand the availability of face masks, barrier face coverings, and face shields for the general public, including health care personnel, as well as surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency
- September 17, 2021: The Vaccines and Related Biological Products Advisory Committee met in open session to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.
- September 16, 2021: FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
- September 10, 2021: COVID-19 Update including approval of an abbreviated new drug application indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting
- September 10, 2021: FDA Will Follow The Science On COVID-19 Vaccines For Young Children
Bookmark www.fda.gov/coronavirus for the latest.
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 COVID-19 vaccine updates
FDA will follow the science on COVID-19 vaccines for young children
We know there have been questions and public commentary on the process surrounding vaccines for young children, so we think it’s important to share information about the process and the necessary considerations involved to provide greater clarity to the public about this effort. Learn about the steps FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children.
 Help stop the spread of coronavirus and protect your family
The COVID-19 pandemic demands that we remain vigilant in our daily lives as we return to everyday activities. We can each take some simple steps to protect ourselves, our families, and our communities.
The steps are:
- Get a COVID-19 vaccine.
- Wash your hands often with plain soap and water.
- Cover your mouth and nose with a mask when around others.
- Avoid crowds and practice social distancing (stay at least 6 feet apart from others).
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Emergency Use Authorization (EUA) updates
FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
FDA revised the EUA for bamlanivimab and etesevimab, administered together (PDF), to include an emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death. Bamlanivimab and etesevimab, administered together, is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus. Bamlanivimab and etesevimab, administered together, should only be used as post-exposure prophylaxis for specific patient populations. Prophylaxis with bamlanivimab and etesevimab, administered together, is not a substitute for vaccination against COVID-19. FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible. Learn more about FDA-approved or -authorized COVID-19 vaccines. (September 16, 2021)
Janssen COVID-19 Vaccine - additional batches authorized
FDA authorized the use (PDF), under the EUA for the Janssen COVID-19 vaccine, of two additional batches of vaccine drug substance manufactured at the Emergent facility on September 14, 2021, and one additional batch (PDF) on September 8, 2021. To date, a total of eight batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.
In vitro diagnostic (test) EUAs
As of September 21, 2021, 410 tests and sample collection devices are authorized by FDA under EUAs. These include 288 molecular tests and sample collection devices, 88 antibody and other immune response tests, and 34 antigen tests. There are 62 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 7 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 15 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 637 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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September 22, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH).
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New! September 28, 2021: Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics, 1:00 - 5:30 p.m. ET, virtual - To share lessons learned from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly known as Operation Warp Speed) to bring relevant therapeutics to use in a public health emergency. More info, including agenda and registration available from Reagan-Udall Foundation for the FDA.
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September 30, 2021: The Vaccines and Related Biological Products Advisory Committee will meet in open session (8:30 a.m. - 3:40 p.m. ET, virtual) to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, and the Center for Biologics Evaluation and Research (CBER), and to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.
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October 4-6, 2021: 11th Annual Global Summit on Regulatory Science, hosted by FDA's National Center for Toxicological Research - This year's theme is Regulatory Sciences for Food/Drug Safety with Real-World Data & Artificial Intelligence (AI).
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October 5, 2021: Enhanced Drug Distribution Security in 2023 Under the DSCSA webinar, 1:00 - 2:00 p.m. ET - To discuss enhanced drug distribution security requirements that go into effect in 2023 under the Drug Supply Chain Security Act (DSCSA), including how enhanced drug distribution security will help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
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Information for industry and health care providers
Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits
FDA issued a Letter to Health Care Providers to alert clinical laboratory staff and health care providers about the potential for false positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. The Letter to Health Care Providers includes important information about Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits including details on potential false positive results, recommendations for clinical laboratory staff and health care providers, actions the FDA is taking and instructions for reporting problems with the Alinity m SARS-CoV-2 AMP or Alinity m Resp-4-Plex AMP Kits. (September 17, 2021)
Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
FDA issued a revised guidance, Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), to help expand the availability of face masks, barrier face coverings and face shields for the general public, including health care personnel, as well as surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency. (September 15, 2021)
Revised guidance: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
FDA revised the guidance Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, originally published in April 2021. The guidance provides general recommendations to prospective generic drug applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency. FDA issued this guidance so that the development of generic drugs and submission of applications can continue during the COVID-19 public health emergency, ultimately helping ensure Americans continue to have access to safe and effective generic drugs. (September 9, 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
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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Learn more about COVID-19 vaccines
Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you. Learn about the evidence supporting FDA approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines.
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FDA Medical Countermeasures Initiative (MCMi) News)
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