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

• Today, the FDA revised the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) to add an authorization of REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19, including hospitalization or death. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus — only after exposure to the virus. REGEN-COV should only be used as post-exposure prophylaxis for specific patient populations. Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible. Learn more about FDA’s COVID-19 vaccination efforts.
• On Wednesday, July 28, the FDA revised the EUA for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury). Baricitinib is not FDA-approved as a treatment for COVID-19.
• On Wednesday, the FDA authorized an extension for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for six months. This extension from four and a half months to six months was granted following a thorough review of data submitted by Janssen and applies to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions. The concurrence letter can be read here.

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