Europe’s regulatory agency endorsed Moderna’s coronavirus vaccine for those 18 and up on Wednesday, paving the way for a second vaccine to roll out among member states. The approval still faces a final decision by the European Commission.
“[European Medicines Agency] EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorization be granted by the European Commission,” reads a statement released by EMA.
President of the European Commission, Ursula von der Leyen, took to Twitter Wednesday announcing that the commission is working to fast-track final approval of the vaccine.
“Good news for our efforts to bring more #COVID19 vaccines to Europeans!” von der Leyen wrote. “@EMA_News assessed that the @moderna_tx vaccine is safe & effective. Now we are working at full speed to approve it & make it available in the EU.”
If approved, Moderna’s vaccine would join a shot developed by Pfizer and BioNTech, which began its rollout to European Union member states on Dec. 27. The EMA faced increasing pressure over its approval process timeline, especially as Britain skipped ahead and granted the Pfizer vaccine temporary authorization and the U.S. gave it the green light earlier last month.
As for Moderna, the EMA cited results from a late-stage clinical trial, showing the vaccine was 94.1% effective at preventing COVID-19 disease among nearly 30,000 trial participants. The Moderna vaccine involves a two-dose regimen, administered 28 days apart, though Germany and Denmark have considered spacing vaccinations further apart, and the latter approved a six week delay between the first shot and the booster on Monday, per Reuters.