COVID-19 vaccine FAQ updates | #VaccineReady toolkit | New streamlined Emergency Use Authorization approach for serial testing

Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:

• April 20, 2021: COVID-19 Update including steps to further facilitate the authorization of tests for pooling specimens from asymptomatic individuals in serial testing programs, and issuance of a pooling and serial testing amendment for many molecular diagnostic COVID-19 tests that had received an emergency use authorization (EUA) for testing individual samples
• April 20, 2021: FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs
• April 16, 2021: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
• April 16, 2021: COVID-19 Update including a warning letter and updates to a frequently asked questions about the Moderna and Janssen COVID-19 vaccines
• April 15, 2021: FDA Voices: A Year Into the Pandemic: How the FDA’s Center for Devices and Radiological Health is Prioritizing its Workload and Looking Ahead
• April 14, 2021: FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

Bookmark www.fda.gov/coronavirus for the latest.

FDA revokes EUA for monoclonal antibody bamlanivimab

Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available

FDA revoked the EUA (PDF) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA. Read more 

Also see: FAQs on the Revocation of the EUA for Bamlanivimab Administered Alone (EUA 90) (PDF) (April 16, 2021) 

FDA announces new streamlined approach to add pooled serial screening claims to certain authorized tests for use in serial testing programs

On April 20, 2021, FDA took steps to further facilitate the authorization of molecular tests for screening asymptomatic individuals using pooled anterior nasal respiratory specimens in serial testing programs. The FDA issued an amendment for many molecular diagnostic COVID-19 tests that had received an EUA. If a test developer self-certifies it has validated its test for pooling and completes other requirements set forth in the letter, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program. Pooling, the process of combining multiple specimens together to more quickly test groups of people for SARS-CoV-2, can be an efficient approach for a serial testing program that tests many people on a routine basis.

The flexibility that the FDA has provided developers continues to be a hallmark of our approach to the COVID-19 pandemic and we will continue to prioritize authorization for tests with the ability to increase testing accessibility or to significantly increase testing capacity. The FDA is committed to assisting our schools, workplaces, communities and other entities with establishing effective testing programs as the national response to the COVID-19 pandemic continues to evolve. Read more  

Diagnostic test EUAs

As of today, 367 tests and sample collection devices are authorized by FDA under EUAs. These include 269 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 23 antigen tests. There are 49 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 2 antigen prescription at-home tests, 4 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 8 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 462 revisions to EUA authorizations. Also see: Coronavirus Testing Basics   

COVID-19 vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines

FDA is vigilant in protecting consumers against COVID-19 vaccine scams

Consumers should know the COVID-19 vaccines that the FDA has authorized for emergency use cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Learn more 

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.