The COVID-19 vaccine developed by Moderna has been cleared by the European Union’s medical regulator, paving the way for the vaccine to be rolled out in the 27-member bloc.
The European Medicines Agency said on Jan. 6 that it was recommending that the vaccine be granted authorization in the EU by the European Commission, the bloc’s executive branch.
Shares in Cambridge, Mass.–based biotech Moderna
rose more than 3% in New York premarket trading on Wednesday.
The EMA said that it “thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorization.”
A conditional marketing authorization is a type of medicine approval based on less comprehensive data than is normally required for approval, but the available data must indicate that benefits outweigh risks.
The European Commission is expected to quickly grant authorization for the vaccine, allowing it to be deployed across Europe, where COVID-19 infections remain very high and millions of people continue to live under strict lockdown measures.
The prospective clearance of the Moderna vaccine comes as governments across Europe face challenges in rolling out the vaccine at scale. In France, President Emmanuel Macron faces national criticism over the inoculation campaign, which lags its European peers.
As of Jan. 1, just 516 people had been vaccinated against the coronavirus disease in France, according to health ministry numbers quoted by the COVIDTracker website. EU neighbor Germany has vaccinated close to 300,000 people. (Some 4.8 million people had received their first vaccine doses as of Tuesday morning in the U.S., according to the Centers for Disease Control and Prevention’s vaccination tracker.)
Emer Cooke, the executive director of the EMA, said that the vaccine “provides us with another tool to overcome the current emergency.”
“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public,” Cooke added. “Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”