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Pfizer/BioNTech COVID-19 Vaccine Wins EU Approval

EMA Denies Any Outside Pressure To Speed Up Decision

 
• By Ian Schofield

The first COVID-19 vaccine will shortly be available to the EU member states, after the European Commission today approved Pfizer/BioNTech's BNT162b2 just hours after the European Medicines Agency issued a positive opinion on the product. The EMA says that uncertainties remain over the ability of the vaccine to prevent transmission of the coronavirus and whether the new variant strain will render this and other vaccines less effective. 

Vaccination against the new Corona Virus SARS-CoV-2: A syringe being drawn up with SARS-CoV-2 vaccination.
The EU is to get its first coronavirus vaccine • Source: Shutterstock

Shipments of the Pfizer/BioNTech COVID-19 vaccine to EU countries are expected to begin soon. The European Medicines Agency recommended EU approval for the product on 21 December and the European Commission issued a formal conditional marketing authorization (CMA) for the vaccine a few hours later.

The EMA said its human medicines committee, the CHMP, had completed a “rigorous” evaluation of the product, which has been named Comirnaty (BNT162b2) in the EU, and that it had decided that “sufficiently robust data on the quality, safety and efficacy of the

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