A dose of Pfizer-BioNTech Covid-19 vaccine at the Hurley Clinic in London, Britain. Picture: REUTERS/PA WIRE/AARON CHOWN
A dose of Pfizer-BioNTech Covid-19 vaccine at the Hurley Clinic in London, Britain. Picture: REUTERS/PA WIRE/AARON CHOWN

Pfizer and BioNTech’s Covid-19 vaccine has won the backing of the European medicines regulator, clearing the way for inoculations to start before the end of 2020 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 (EMA) on Monday. The final step in approval is a sign-off from the European Commission, expected later in the day.

“It is a significant step forward in our fight against this pandemic,” Emer Cooke, executive director of the EMA, 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 has 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.

EU leaders pushed the regulator to speed up its review amid complaints that residents across the continent are still waiting to get a vaccine — pioneered in Germany — that is already being used in the UK and US. The goal is to start a European immunisation campaign on December 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.

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 UK amid an effort to contain a variant of the coronavirus that officials say is spreading quickly across London and southeast England.

Unlike the US and UK, which conducted emergency authorisations, the EMA reviewed the vaccine for a conditional marketing authorisation. 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 from Moderna, with a key meeting set for January 6.



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