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

Related Content

NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks

The National Institute for Health and Care Excellence (NICE) has announced that it has recommended …

FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has …

FDA approves first oral antiviral to treat adult patients with COVID-19

The US Food and Drug Administration (FDA) has announced that it has approved the oral …

Latest content