EU Considers Giving EMA Fast-Track Authority to Adapt COVID-19 Vaccines

The European Commission (EC) aims to speed authorizations of vaccines adapted to fight new SARS-CoV-2 variants by giving the European Medicines Agency (EMA) fast-track authority.

The proposed measure — which needs and is likely to get the approval of the European Parliament and Council of the European Union — would allow drugmakers to submit a smaller set of data for adapted vaccines for authorization to the EMA, an approach already permitted for adapting influenza vaccines to new strains.

“Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said EC President Ursula von der Leyen.

The commission is also still considering a new emergency approval mechanism to replace its time-consuming conditional marketing authorization process.