On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1).1 The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty for all persons ≥16 years old, citing a lack of adequate data.
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RELEASE
Merck and Ridgeback Biotherapeutics have announced that they will submit an application to the FDA for Emergency Use Authorization (EUA) for their investigational oral antiviral drug molnupiravir for treatment of COVID-19.1 If the EUA is granted, molnupiravir would be the first oral antiviral drug to be authorized in the US for treatment of COVID-19. The ...
