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EU regulator clears Johnson & Johnson's coronavirus vaccine


Johnson & Johnson's coronavirus vaccine won clearance from the European Union's drugs regulator, paving the way for the first single-injection shot to help bolster the region's sluggish vaccination campaign.

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The European Medicines Agency recommended that the EU grant the vaccine conditional approval for all adults in a statement Thursday. The European Commission said it will move quickly to rubber-stamp the decision.

The newcomer could help the bloc ramp up its immunization effort because it can be stored in a refrigerator for long periods -- unlike two of the other three vaccines available in the EU -- and the logistics of injecting a single dose are far simpler. The shot protected all volunteers in clinical trials against hospitalization and death from covid-19.

The EU has purchased 200 million doses of the vaccine, with an option for 200 million more. The Commission had said previously deliveries were expected to begin in early April, but officials are now bracing for delays, two people with knowledge of the process said earlier this week. At a meeting of EU ambassadors Wednesday, diplomats were told J&J has yet to provide a delivery schedule for the shot.

The vaccine is the fourth to be cleared in the region after those made by AstraZeneca Plc and the University of Oxford, Pfizer Inc. and partner BioNTech SE, and Moderna Inc.

The EMA's "recommendation is a landmark moment for Johnson & Johnson and for the world," said Paul Stoffels, the drugmaker's chief scientific officer, in a statement.

The EU's vaccination program has faced criticism for its slow rollout, prompting Commission President Ursula von der Leyen to lash out earlier this week, saying the bloc's executive arm is "tired of being the scapegoat." Instead she refocused the blame on manufacturers like Astra, which has delivered fewer vaccines than promised.

The J&J vaccine was found to be 67% effective against symptomatic covid-19 in trials, a number that was affected by the prevalence of new variants of the virus at some study sites such as South Africa. In the U.S. arm of the studies, the vaccine prevented 72% of infections.

That's less protection than what vaccines from Pfizer-BioNTech and Moderna offer, but its ease of use makes up for that, especially since it affords protection against severe disease. Side effects include headaches, tiredness and pain at the injection site.

"As a cheap, easily shipped and stored vaccine, it will play a key role," Sam Fazeli, an analyst at Bloomberg Intelligence, wrote in a note after the shot won clearance from the U.S. Food and Drug Administration last month.

Like the Astra vaccine, the J&J shot uses an adenovirus, similar to the virus that causes the common cold, to deliver the genetic material into the body to provoke a defense against covid-19. The Oxford-Astra vaccine uses a chimpanzee adenovirus to do this, while J&J's is derived from humans.

The U.S. began rolling out the shot last week, following the FDA's emergency-use authorization. Through Operation Warp Speed the U.S. has provided about $1.5 billion in funding for the vaccine in exchange for 100 million doses, with the option to purchase more. The company is also conducting a two-dose trial of its shot.

The U.K., where some of J&J's advanced trials were conducted, has purchased 30 million doses of the vaccine, but hasn't yet cleared it for use.

Published : March 12, 2021

By : Syndication Washington Post, Bloomberg · Suzi Ring, Nikos Chrysoloras