The United States FDA has made PAXLOVID™ available under an emergency access
mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a
Secretary of Health and Human Service (HHS) declaration that circumstances exist to
justify the emergency use of drugs and biological products during the COVID-19
Pandemic.
PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults and children
[12 years of age and older weighing at least 88 pounds (40 kg)] 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, has not undergone the same type of
review as an FDA-approved product. In issuing an EUA under the COVID-19 public
health emergency, the FDA has determined, among other things, that based on the
total amount of scientific evidence available including data from adequate and
well-controlled clinical trials, if available, it is reasonable to believe that the product may
be effective for diagnosing, treating, or preventing COVID-19, or a serious or
life-threatening disease or condition caused by COVID-19; that the known and potential
benefits of the product, when used to diagnose, treat, or prevent such disease or
condition, outweigh the known and potential risks of such product; and that there are no
adequate, approved, and available alternatives.
All of these criteria must be met to allow for the product to be used in the treatment of
patients during the COVID-19 pandemic. The EUA for PAXLOVID™ is in effect for the
duration of the COVID-19 declaration justifying emergency use of this product, unless
terminated or revoked (after which the products may no longer be used under the EUA).