Pfizer, BioNTech apply for coronavirus vaccine approval in Europe

Covid-19, Health, Fitness & Food

A volunteer is injected with a vaccine as he participates in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020.

Marco Bello | Reuters

U.S. pharmaceutical giant Pfizer and its German partner BioNTech said they have applied to the European Medicines Agency for the conditional marketing authorization of their coronavirus vaccine.

Such authorization is granted to medicines or vaccines “that address unmet medical needs of patients on the basis of less comprehensive data than normally required,” the EMA says on its website..

The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.

If a CMA is granted, it could potentially enable use of Pfizer and BioNTech’s vaccine in Europe before the end of 2020, BioNTech said in a press release.

This is a breaking news story, please check back later for more.

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