Johnson & Johnson is working with European Union regulators to assess data on rare clots, and “ at this time, no clear causal relationship has been established ” with the vaccine, the company said in a press release sent by email.
The European Union medicines regulator has launched a review to assess blood clots in people who have received the Covid-19 vaccine from Johnson & Johnson.
Four severe cases of unusual clots accompanied by low blood platelets, one of which was fatal, occurred after vaccination with the J&J vaccine, the European Medicines Agency said on Friday. The regulator is currently examining potential safety concerns for two Covid vaccines, after the AstraZeneca Plc shot may have been linked to a rare blood clotting disorder.
J&J is working with regulators to assess data on rare clots, and “at this time, no clear causal relationship has been established” with the vaccine, the company said in an email statement. Shares traded up to 1.6% less.
One of the cases following the J&J vaccinations occurred during a clinical trial. At the time, the company said it had found no evidence that the vaccine was at fault. Three more occurred in the United States, where the shot was given to nearly 5 million people.
Although J & J’s vaccine is approved in the EU, its deployment in the bloc is not expected to begin until later this month. Still, the EU is counting on the single-dose vaccine to boost its vaccination campaign amid restrictions in some countries on the use of the AstraZeneca vaccine, which requires two doses.
The EU regulator has also launched a review to assess five reported cases of a rare disease called capillary leak syndrome in people who have received the AstraZeneca vaccine. The EMA said it was not clear whether the vaccine was linked to the disorder, in which fluid leaking from blood vessels caused tissue swelling and blood pressure to drop.
Separately, the EU regulator said it did not yet have enough evidence to approve Russia’s Sputnik V vaccine.
J&J, Astra, and Sputnik injections all use an adenovirus – the cause of some colds – to deliver the coronavirus antigen and generate an immune response.
Adenoviral technologies such as those used by AstraZeneca and others have been associated with coagulation in other settings, so if this is the reason for the rare side effects seen with the Astra vaccine, injections of J&J, Sputnik and the Chinese drug maker CanSino Biologics Inc. would also be. be in danger, said Sam Fazeli, analyst at Bloomberg Intelligence.
The Food and Drug Administration did not immediately respond to a request for comment.
The number of clot cases in people who have taken the J&J vaccine has so far been low compared to the total number of people receiving the vaccine globally, said Peter Arlett, EMA chief analyst. , April 7. At this point, Arlett said three clotting cases had been discovered, while 4.5 million people had been vaccinated against J&J.
“I think it would be fair to say that there is intensive surveillance for this problem through vaccines,” Arlett said.
The EMA will continue its continued review of the Russian vaccine until it has enough evidence to support a marketing authorization application, the agency said on Friday. The EMA declined to comment on security information for Sputnik until its assessment was complete.