EU may authorise extra doses from vials of Pfizer Covid-19 vaccine - source

Eu May Authorise Extra Doses From Vials Of Pfizer Covid-19 Vaccine - Source
An approval amendment could permit the extraction of six doses from a vial instead of five. Photo: Getty Images.
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Thomson Reuters

The European drugs regulator could shortly approve an amendment to its approval of the Pfizer-BioNTech Covid-19 vaccine that would permit the extraction of six doses from a vial instead of five, an EU official told Reuters on Wednesday.

The source, who asked to remain anonymous because discussions are not public, said the change to the authorisation could come "very soon".


The European Medicines Agency (EMA) recommended on December 21st the conditional approval of the Pfizer vaccine. Under that authorisation, five doses should be extracted from each vial.

Europe began its vaccination drive on December 27th but it has had an uneven start as cases continue to surge across the continent and worldwide.

The Pfizer/BioNTech vaccine was the first to be approved by the EMA in December, with Moderna's vaccine — which is easier to store and transport — becoming the second to win its endorsement on Wednesday.


Some EU member states were frustrated at the length of time the EMA took to decide on the Pfizer-BioNTech shot, leaving it lagging behind the United States, Britain, Israel and Switzerland in approving and administering the first vaccines.

However, the regulator has given a conditional marketing approval for both approved vaccines, rather than the ultra-fast emergency use clearance issued by Britain, which it says requires more detailed study of the data.

Meanwhile, Ukrainian police and health officials are investigating reports that some citizens have been illegally getting inoculated against Covid-19 with vaccines that have not been officially approved.

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