Emergency Use Authorization (EUA) is a status given to experimental and licensed products by the FDA during a public health emergency, as defined under federal law.
Monoclonal Antibodies
In 2020, the FDA issued EUAs for several monoclonal antibodies to treat COVID-19. Monoclonal antibodies are laboratory produced synthetic versions of antibodies and included the drugs baricitinib, bamlanivimab, casirivimab, imdevimab, etesevimab, sotrovimab, and bebtelovimab. In 2021, Evusheld, a long-acting COVID-19 preventative monoclonal antibody received EUA status by the FDA for persons 12 years and older considered immunocompromised or for those unable to receive a COVID-19 vaccine.
By December 2022, however, health officials reported that monoclonal antibodies were no longer an effective treatment against the circulating SARS-CoV-2 strains found in the U.S. As of August 27, 2023, all EUAs for monoclonal antibodies targeting the SARS-CoV-2 virus have been revoked.
Anti-Viral Medications
In December 2021, the FDA issued an EUA for Molnupiravir, an oral anti-viral, for the treatment of mild to moderate COVID-19 illness in SARS-CoV-2 positive adults considered at high risk for severe COVID-19 illness, including hospitalization and death when other FDA authorized treatments are not available or appropriate.
Molnupiravir, manufactured by Merck, is authorized for use in adults 18 years and older for the treatment of COVID-19 illness who are positive for SARS-CoV-2 and at risk of severe illness. According to clinical trials, of the 709 individuals who received molnupiravir, 6.8 percent required hospitalization compared to 9.7 percent of the 699 individuals who received the placebo. One person who received molnupiravir died, compared to nine people who received the placebo. This experimental medication is not recommended for use in pregnant women because animal reproductive studies appear to indicate a risk of fetal harm. Reported side effects include diarrhea, nausea, and dizziness.
Some scientists have expressed concern about Molnupiravir because it is capable of mutating RNA and could potentially cause new and possibly deadlier virus variants.61
