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Pfizer: files for European approval of Covid vaccine

(CercleFinance.com) - Pfizer and BioNTech said on Tuesday that they have filed for European approval for their mRNA vaccine candidate against the Covid-19 virus.


The companies said that they have submitted a formal application for conditional marketing authorization to the European Medicines Agency (EMA).

If EMA concludes that the benefits of the vaccine candidate outweigh its risks, it will recommend granting an approval that could potentially enable use of the vaccine in Europe before the end of 2020, they said.

Data showed the vaccine had an efficacy rate of 95% in the companies' Phase 3 clinical study.

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