MedWatch

EMA backs standard approval of two Covid-19 vaccines

The European Medicines Agency’s expert committee now supports full authorization of Moderna and Pfizer-Biontech’s vaccines, which have so far only been conditionally approved.

Photo: Hannah Beier/Reuters/Ritzau Scanpix

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its positive recommendation for the standard authorization of the Covid-19 vaccines developed by Moderna and the Pfizer-Biontech partnership, a press release announces.

The two vaccines, Comirnaty and Spikevax, were granted conditional marketing authorization at the time of approval, a stamp usually given to medicines that patients need urgently, and for which there therefore aren’t a complete data set when it comes to effects and potential side-effects. Such an approval is only given if the safety and efficacy of the drug theoretically exceed the theoretical risk of not having all data.

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