Receives coronavirus vaccine applications

EU regulator receives coronavirus vaccine applications from BioNTech/Pfizer, Moderna

The two companies submitted conditional marketing authorization applications to the European Medicines Agency.

BY JILLIAN DEUTSCH

European regulators could approve two coronavirus vaccines “within weeks,” the European Medicines Agency wrote Tuesday.

Both BioNTech/Pfizer and Moderna submitted conditional marketing authorization (CMA) applications to the European Medicines Agency (EMA) this week.

The agency has already examined some of the data from both companies via a “rolling review,” allowing the agency to speed up the authorization of the vaccines, the EMA wrote.

“If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA that could potentially enable use of [the vaccine] in Europe before the end of 2020,” BioNTech wrote in a press release.

In November, both developers announced their vaccines were highly effective based on preliminary results of large-scale trials: The German-American partnership said their vaccine is 95 percent effective, and Moderna announced theirs is 94 percent effective.

The Commission has secured up to 300 million doses of the BioNTech/Pfizer vaccine, and 160 million doses of Moderna’s vaccine. The U.K. has secured 40 million from BioNTech/Pfizer, and another 7 million from Moderna.

Still, Moderna has said its initial 20 million vaccine doses will be made and used for the U.S., and the company hopes to supply globally in 2021.