EMA receives Pfizer and BioNTech’s filing for conditional approval of COVID-19 vaccine in Europe

pharmafile | December 1, 2020 | News story | Manufacturing and Production, Sales and Marketing |  BioNTech, COVID-19, EMA, Pfizer, Vaccine 

Pfizer and BioNTech have officially submitted their application to secure conditional marketing authorisation to the European Medicines Agency (EMA) for its mRNA-based COVID-19 vaccine candidate BNT162b2, the agency has confirmed.

Hopes are high for Pfizer and BioNTech’s vaccine after it recently demonstrated 95% efficacy in global Phase 3 trials, with this efficacy maintained in at-risk groups such as over-65s. The developers said that, on successful approval, roll-out could commence before the end of the year.

The EMA will now review the application under an accelerated timeframe. The agency has been conducting a rolling review of all available data on the candidate since earlier in the year, enabling it to make an authorisation decision much faster than usual; it is expected that a final decision could be reached within weeks if the data supporting the application is strong enough.

Meanwhile, US rival Moderna, whose own mRNA vaccine showed final efficacy rates of 94.1%, announced its intentions to also file for approval in Europe this week.

Matt Fellows