The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• On Wednesday, the FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information regarding:
  • Background information on the SARS-CoV-2 omicron variant
  • Impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests
  The update revised:
  • The FDA’s recommendations for clinical laboratory staff and health care providers.
  • Information on the impact of the SARS-CoV-2 omicron variant on molecular diagnostic tests 
• Today, ASPR and the FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies. Data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant. FDA updated the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered together, REGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant (B.1.1.529/BA.1). Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun. An additional 300,000 doses of sotrovimab will be available for distribution in January. As additional data become available, FDA and ASPR will provide updates and further recommendations and consider if additional actions are warranted.  
• This week, the FDA authorized two oral antivirals for the treatment of COVID-19 in certain patients. Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) is authorized 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 or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Merck’s molnupiravir is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Both treatments are available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
• Testing updates:
  • As of today, 418 tests and sample collection devices are authorized by the FDA under emergency use authorizations (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 one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
  • The FDA has authorized 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 738 revisions to EUA authorizations.

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