E.U. regulator approves J&J's one-shot Covid-19 vaccine

AMSTERDAM – The European Medicines Agency has approved Johnson & Johnson’s unique coronavirus vaccine. This means that the 27 states of the European Union will receive a fourth approved vaccine to contain the pandemic in the course of a stalled vaccination campaign in the block.

In a decision made on Thursday, the E.U. The Medicines Agency recommended that the vaccine be approved for all adults over the age of 18 “after a thorough evaluation” of J & J’s data. It was found that the vaccine met the criteria for effectiveness, safety and quality.

“With this recent positive opinion, authorities across the European Union have yet another opportunity to fight the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA Executive Director.

The EMA has already approved Covid-19 vaccines from Pfizer-BioNTech, Moderna and AstraZeneca. However, all of these vaccines require two doses several weeks apart.

In its statement, the EMA said the J&J vaccine was 67 percent effective.

The U.S. Food and Drug Administration approved the J&J shot in late February. Health experts hope that a single-dose vaccine will accelerate efforts to immunize the world against Covid-19, especially given that worrying new variants have been added in recent months.

The EU. has struggled to fire quick shots and immunize the most vulnerable citizens. It lags far behind countries like Israel, the UK, Chile, and the US.

Europe saw 1 million new Covid-19 cases last week, a 9 percent increase from the previous week and a reversal that ended a six-week decline in new infections. The World Health Organization’s European office made the increase attributable in part to virus variants, including one first identified in the UK that is believed to be 50 percent more transmissible.

A massive study spanning three continents found the J&J vaccine was 85 percent effective against serious illness, hospitalizations, and death. This protection has also remained strong in countries like South Africa, where variants have been identified that appear to be less susceptible to other approved vaccines, including the one made by AstraZeneca.

J&J is also applying for emergency approval for its vaccine in the UK and with the World Health Organization. The company hopes to produce around 1 billion cans this year. The vaccine was also approved for use in Bahrain and Canada.

Experts say a fourth vaccination option across Europe, especially one that only requires one dose, could help immunize people faster, although significant amounts of the shot are unlikely to be available by the second half of 2021.

J&J has experienced production delays in the US and Europe, but recently signed agreements with competing drugs that will help manufacture their vaccine.

In February, Sanofi Pasteur announced that if the shot was approved, approximately 12 million doses of the J&J vaccine could be made at one of its French manufacturing facilities.

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