Pfizer Inc. and BioNTech SE’s Covid-19 vaccine won the backing of the European medicines regulator, clearing the way for inoculations to start before the end of the year as the continent struggles with rising death rates and tighter lockdowns.
The endorsement of the vaccine, Comirnaty, was announced in a news briefing by the European Medicines Agency on Monday. The final step in approval is a sign-off from the European Commission, expected later today.
“It is a significant step forward in our fight against this pandemic,” Emer Cooke, executive director of the agency, said in the meeting. “This is really a historic scientific achievement.”
EMA officials said there’s no evidence to suggest the vaccine won’t work against the new variant of the coronavirus that emerged in southeast England, leading to an emergency lockdown in London and causing countries including Canada, France and Germany to halt flights and suspend rail links.
European Union leaderspushed the regulator to speed up its review amid complaints that residents across the continent were still waiting to get a vaccine —pioneered in Germany — that is already being used in the U.K. and U.S. The goal is to start a European immunization campaign on Dec. 27, commission President Ursula von der Leyen said last week.
Monday’s recommendation puts the EU in position to meet that timeline. Von der Leyen said in a tweet that she expects the commission to act swiftly, with a decision by tonight.
The trials showed the vaccine was effective in preventing Covid-19 in people from 16 years of age, the agency said in a statement.
Just as Europe prepares to roll out the first vaccine, countries are suspending travel links to the U.K. amid an effort to contain a variant of the coronavirus that officials say is spreading quickly across London and southeast England.
Unlike the U.S. and U.K., which conducted emergency authorizations, the EMA reviewed the vaccine for a conditional marketing authorization. Such a decision requires more evidence, the EU commission’s directorate-general for health said last week. The EMA committee is also reviewing a similar vaccine fromModerna Inc., with a key meeting set for Jan. 6.
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