EMA recommends Comirnaty, first COVID-19 vaccine for authorization

The European Medicines Agency’s advisory committee today recommended granting a conditional marketing authorization for Pfizer (NYSE: PFE) and BioNTech’s (Nasdaq: BNTX) vaccine Comirnaty (previously known as BNT162b2), to prevent COVID-19 in people from 16 years of age.

The EMA’s scientific opinion paves the way for the first marketing authorization of a COVID-19 vaccine in the European Union by the European Commission, with all the safeguards, controls and obligations this entails.

BNT162b2 gained its first emergency use approval at the start of the month from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and swiftly thereafter also by the US Food and Drug Administration. To date, the vaccine has been authorized or approved for emergency or temporary use in more than 15 countries.