EU regulator approves Johnson & Johnson’s one-shot COVID-19 vaccine

AMSTERDAM —  The European Medicines Agency has authorized Johnson & Johnson’s one-dose COVID-19 shot, giving the European Union a fourth licensed vaccine to fight the pandemic as its vaccination drive continues to proceed much more slowly than hoped.

In a decision issued Thursday, the EU medicines regulator said it was recommending that the vaccine be authorized for all adults over 18 “after a thorough evaluation” of Johnson & Johnson’s data found the vaccine met the criteria for efficacy, safety and quality.

“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.

The EMA has already approved COVID-19 vaccines made by Pfizer, Moderna and AstraZeneca. All of those vaccines require two doses, several weeks apart.

In its statement, the EMA said the Johnson & Johnson vaccine was about 67% effective.

The U.S. Food and Drug Administration approved the Johnson & Johnson shot in late February. Health experts hope that having a one-dose vaccine will speed efforts to immunize the world against COVID-19, especially given the arrival of worrying new variants in recent months.

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The EU has struggled to roll out vaccinations quickly and immunize its most vulnerable citizens. It ranks far behind countries such as Israel, Britain, Chile and the U.S.

Europe recorded 1 million new COVID-19 cases last week, an increase of 9% from the previous week and a reversal that ended a six-week decline in new infections. The World Health Organization’s European office blamed that surge partly on coronavirus variants, including one first identified in Britain that is thought to be 50% more transmissible.

A massive study spanning three continents found that the Johnson & Johnson vaccine was 85% effective in protecting against severe illness, hospitalizations and death. That protection remained strong even in countries such as South Africa, where variants have been identified that appear to be less susceptible to other licensed vaccines, including the one made by AstraZeneca.

Johnson & Johnson is also seeking emergency authorization of its vaccine in Britain and by the World Health Organization. The company is hoping to make about 1 billion doses this year. The vaccine has also been approved for use in Bahrain and Canada.

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Experts say that having a fourth vaccine option across Europe, especially one that requires only one dose, could help immunize people more quickly, even though significant amounts of the vaccine are unlikely to be available until the second half of 2021.

Johnson & Johnson has faced production delays in the U.S. and Europe but has recently signed agreements with rival pharmaceutical companies that will help make their vaccine. In February, Sanofi Pasteur said it would be able to make about 12 million doses of the Johnson & Johnson vaccine at one of its French production sites once the shot is approved.