The European Medicines Agency has authorized Johnson & Johnson’s one-shot Covid-19 vaccine Thursday, the fourth to get the green light for use across the 27-nation bloc that has struggled to get its vaccination program off the ground amid severe supply chain issues, diplomatic spats and bureaucratic red tape.
The agency said it was recommending authorization of the shot on Thursday after a “thorough evaluation” of safety data from Johnson & Johnson, adding that the vaccine was “robust and met the criteria for efficacy, safety and quality.”
The authorization—coming days after the shot was approved in the U.S.—clears the vaccine for use in people over the age of 18 across the European Union.
“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director.
Cooke emphasized that this was the first vaccine approved to be used in the bloc as a single dose, which could help speed up struggling vaccination efforts.
A large-scale clinical trial of the vaccine found it to be about 67% effective at preventing moderate to severe cases of Covid-19 after two weeks of receiving the shot.
The regulator said it would continue to monitor the safety and effectiveness of the vaccine as it is distributed, with the study indicating side effects to be “usually mild or moderate and cleared within a couple of days,” with the most the most common being pain at the injection site, headache, tiredness, muscle pain and nausea.
The European Union’s vaccination program has been plagued by supply chain issues, with the bloc accusing companies like AstraZeneca of breaking contracts to make a profit elsewhere after major suppliers said deliveries would fall well short of projections. In response, officials implemented controversial export-blocking regulations to prevent companies shipping out vaccine doses when commitments to the EU have not been met. The vaccine crisis is quickly becoming a diplomatic one after Italy blocked a shipment of 250,000 doses to Australia and a senior official accused the U.S. and U.K. of implementing export bans of their own, a comment which drew swift rebuke from Britain’s government.
43 million. This is roughly how many vaccine doses have been administered across the bloc.
How Europe fell behind on vaccines (Politico)
Source: Forbes – Business