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EU agency: Pfizer/BioNTech vaccine could be approved ‘within weeks’

The European Medicines Agency (EMA) will decide whether to approve the Pfizer/BioNTech vaccine "within weeks" if the data provided is robust enough, the EU regulator says.

The European Medicines Agency (EMA) will decide whether to approve the Pfizer/BioNTech vaccine “within weeks” if the data provided is robust enough, the EU regulator says.

“An opinion on the marketing authorisation could be issued within weeks depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine,” the EMA says.

Its assessment would be concluded during an extraordinary meeting scheduled for 29 December “at the latest,” it adds.

The only other company that has already requested EU market authorization for its candidate – Moderna – can expect a decision by January 12 at the latest.

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