Pfizer vax gets CHMP green light in EU

Dec. 21, 2020

Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) have green lighted the drugmakers' COVID-19 vaccine, setting the stage for full approval.

CHMP's positive opinion to recommend the conditional marketing authorization BNT162b2 for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus means a European Commission decision is expected imminently. Before the 27-nation bloc can begin its rollout, the European Commission must give its final approval.

If approved, the vaccine's first EU rollout is set to begin on December 27.

The EMA's recommendation comes as a new, fast-spreading variant of the virus has been detected in countries across Europe. While experts don't expect that the mutation will compromise the strength of the vaccine, more data is still needed.

The U.S. FDA granted the Pfizer and BioNTech vaccine emergency use authorization on Dec. 11, just one day after the FDA's Vaccines and Related Biological Products Advisory Committee voted in favor of the EUA. Pfizer and BioNTech are now gathering additional data and preparing to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.

Read the press release about CHMP's positive opinion