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Opens up additional European sites for dose manufacturing
Today, the European Medicines Agency (EMA) approved new manufacturing sites for coronavirus vaccines made by AstraZeneca, Pfizer-BioNTech and Moderna, in a decision that could increase Europe’s supply of the shots and help accelerate vaccination efforts across the continent, as reported by AP.
The EMA said in a statement that it had approved sites in the Netherlands, Germany and Switzerland for the Covid-19 vaccines made by the companies.
More specifically, the agency has approved a factory in Leiden, the Netherlands, to make the active substance for AstraZeneca’s vaccine, bringing the number of such licensed sites to four; the agency was also providing the go-ahead to a site in Marburg, Germany, to make both the active substance and completed vaccine developed by Pfizer and BioNTech.
Also, the EMA said it would be granting “more flexible storage conditions” to the Pfizer-BioNTech vaccine, which was initially restricted to ultra-low temperatures (ULT) for storage and delivery. And last week, an expert committee at the EMA recommended new manufacturing lines at a facility in Visp, Switzerland, for the Moderna vaccine.
All Covid-19 vaccines that are designated for use in the EU must have their manufacturing sites approved by the EMA after a regulatory evaluation.