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.
This alert has been updated with a statement from the European Medicines Agency.
This article is part of POLITICO’s premium policy service: Pro HealthCare. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.
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