Pfizer/BioNTech's covid vaccine approved in the EU
Now that the European Commission has made its decision, it will be possible to initiate vaccination throughout the EU.
EMA's evaluation of Comirnaty, as the vaccine is called, has shown that the vaccine meets the EU's requirements for safety, efficacy, quality and manufacturing.
"Together with the other EU Member States, we have concluded that the benefits of the vaccine outweigh any possible risks involved. The fact that there will soon be an approved vaccine in the European market is an important piece of the puzzle in fighting the pandemic," says Charlotta Bergquist, vaccine coordinator at the Swedish Medical Products Agency.
The clinical trials, with approximately 44,000 participants, investigated how well Comirnaty protected people who had not had Covid-19 previously. Overall, the trial showed that the vaccine provides 95% protection against Covid-19.