- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On August 27, the FDA made changes to the authorized use of the monoclonal antibodies bamlanivimab and etesevimab, administered together. The Emergency Use Authorization now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized, and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together, are not currently authorized, and will periodically update both lists as new data and information becomes available.
- On August 30, FDA issued a letter to veterinarians and retailers asking for assistance in sharing important safety information with consumers about the dangerous misuse of animal ivermectin to prevent or treat COVID-19 in people. As noted in many recent news stories and in a Health Alert from the U.S. Centers for Disease Control and Prevention, poison control centers across the U.S. are seeing a sharp spike in reports of people suffering adverse health effects after taking animal ivermectin. People are purchasing various highly concentrated animal ivermectin drug formulations such as “pour-on,” injectable, paste, and “drench” that are intended for horses, cattle, and sheep, and taking these drugs has made some people very sick. Even if animal drugs have the same active ingredient as an approved human drug, animal drugs have not been evaluated for safety or effectiveness in humans. Treating human medical conditions with veterinary drugs can be very dangerous.
- Testing updates:
- As of today, 409 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 287 molecular tests and sample collection devices, 88 antibody and other immune response tests and 34 antigen tests. There are 61 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, seven antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 14 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 619 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Chanapa Tantibanchachai