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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:
- February 15, 2022: FDA Roundup including a warning letter to the operator of a website for offering for sale in the U.S. unapproved drugs for multiple diseases, including COVID-19
- February 11, 2022: New web page from FDA's Center for Biologics Evaluation and Research (CBER): International Engagements to Respond to COVID-19 Pandemic
- February 11, 2022: FDA Roundup including approval of an abbreviated new drug application for a product, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
- February 11, 2022: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 That Retains Activity Against Omicron Variant
- February 11, 2022: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age - a recording of a February 11, 2022 media call is also available
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 therapeutics update
FDA authorizes new monoclonal antibody for treatment of COVID-19 that retains activity against omicron variant
FDA issued an Emergency Use Authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
Related links (PDFs):
2021 generic drugs report
Innovation and scientific collaboration moved the generic drug program forward in 2021
In 2021, FDA prioritized the assessment of generic drug application submissions for drugs identified as potential treatments and supportive therapies for patients with COVID-19. COVID-19 related submissions included more than 75 original ANDAs, some which we approved in record time, as well as more than 1,200 supplemental applications. Also see the Office of Generic Drugs 2021 Annual Report. (February 14, 2022)
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Emergency Use Authorization (EUA) updates
EUA updates
On February 9, 2022, FDA issued a letter granting an EUA amendment (PDF) for COVID-19 Convalescent Plasma to include the EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG) test as an acceptable test for use in the manufacture of high titer COVID-19 Convalescent Plasma. An updated list of acceptable tests is available in Appendix A of the COVID-19 Convalescent Plasma EUA Letter of Authorization (PDF).
EUA revocation
FDA revoked the following EUA for a test that is no longer being used:
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 February 15, 2022, 421 tests and sample collection devices are authorized by FDA under EUAs. These include 291 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 45 antigen tests. There are 70 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, 15 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 26 antigen tests and 10 molecular tests for serial screening programs. The FDA has also authorized 826 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
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February 23, 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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March 3, 2022: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2022-2023 influenza season.
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March 7-9, 2022: FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual)
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April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
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Information for industry and health care providers
Do your patients have vaccine questions?
Bookmark and share FDA's video frequently asked questions about COVID-19 vaccines, and the Multilingual COVID-19 Vaccines Myths Social Media Toolkit, available in English, Spanish, Simplified Chinese, Korea, Tagalog, and Vietnamese.
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
Find a COVID-19 vaccine or booster near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.
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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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