Johnson & Johnson’s Single-Shot Covid Vaccine Approved by EU
(Bloomberg) -- Johnson & Johnson’s coronavirus vaccine won clearance from the European Union, adding the first single-dose shot to the bloc’s arsenal as it seeks to speed up a sluggish immunization campaign.
The European Commission granted a conditional marketing authorization after the EU’s drugs regulator recommended approval for all adults earlier Thursday. It’s the fourth shot 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 newcomer could help the bloc ramp up its immunization effort because it can be stored in a refrigerator for long periods -- unlike the Pfizer and Moderna vaccines -- 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.
J&J said in a statement after the announcement that it would aim to begin deliveries to the EU in the second half of April and would supply 200 million doses to the bloc, Norway and Iceland in 2021.
Paul Stoffels, the drugmaker’s chief scientific officer, called the EU’s approval “a landmark moment for Johnson & Johnson and for the world.” J&J shares rose 0.4% in early U.S. trading.
The EU’s vaccination program has faced criticism for its slow roll-out, 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. portion of the studies, the vaccine prevented 72% of infections.
“These are the best data we have seen,” Thomas Mertens, the head of Germany’s vaccine commission, said on a video call with foreign media. He praised the way the trials were conducted and presented, and said the country would likely endorse the shot within weeks.
The protection is below what the 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.
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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.
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