Johnson & Johnson will deliver its Covid-19 vaccine to the The European Union after the bloc’s drug regulator said the benefits of the shot outweigh the risks of a possible link to cases of rare blood clots.
The Review by the European Medicines Agency on Tuesday echoed its review of the vaccine AstraZeneca Plc, which has also been associated with the rare clot. In both cases it is the supervisor noted that Covid can be fatal and the use of vaccines is crucial to fight the virus.
“The global death toll from Covid-19 is more than 3 million cases worldwide, and thousands of people are still dying every day,” said Emer Cooke, EMA’s executive director. “There is untold human suffering behind all of these cases, and these vaccines play a hugely important role in fighting this pandemic.”
In its decision, the EMA said the blood clots should be listed as very rare side effects so doctors and patients can keep an eye out for any danger signs. That allows EU governments to make their own decisions about whether or not to limit use to certain age or patient groups, as many have done with the similar shot from Astra.
J&J will also seek to raise awareness of the symptoms of the rare blood clots to ensure they are properly diagnosed and treated, Paul Stoffels, the company’s chief scientific officer, said in a statement. Physicians are advised not to use the anticoagulant heparin.
The EMA said its own independent research will continue, including research into the blood clots associated with various vaccines. In addition, the regulator will publish an update on its investigation into Astra’s vaccine by the end of the week.
The problems with J&J, which stopped supplies of the vaccine in Europe last week, were another blow to the block’s immunization program. The rollout had been starts picking up after a slow start due to Astra shipments delays and security issues. Both shots were meant to be pivotal in the drive to inoculate 70% of the bloc’s adult population by the end of the summer.
Shares in J&J rose by no less than 2.9% on Tuesday. The company reported a stronger-than-expected first quarter earlier sale.
The US authorities are expected to follow suit with their own ruling on the Covid vaccine by Friday, after pausing use of the J&J recording last week. One option would be to allow the use of the shot with some form of restriction or warning, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Sunday.
There are eight reports in the US – of the more than 7 million people who got the shot – of one severe form of blood clot combined with low platelet count within three weeks of immunization. The cases occurred in people between 18 and 49 years old, with a mean age of 33 years, and most were in women.
The single-dose J&J injection, like the two-injection injection developed by Astra and the University of Oxford, uses an adenovirus to deliver genetic material into the body to provide a defense against Covid-19. to encourage.
The 27-nation EU is unlikely to renew contracts with both Astra and J&J, but will instead prioritize the messenger RNA vaccines made by the Pfizer Inc.-BioNTech SE alliance and Moderna Inc., France’s industry minister, said last week. With booster shots likely to be needed, the European Commission is already in talks with Pfizer and BioNTech for a whopping 1.8 billion additional doses through 2023.
(Updates with J&J comment in fifth paragraph, EMA update on Astra in sixth)