Johnson & Johnson is working with EU regulators to assess data on rare clots and “at present, no clear causal relationship has been established” with the vaccine, the company said in an email.
The European Union’s drug regulator has begun a review to assess blood clots in people who have received the Johnson & Johnson Covid-19 vaccine.
Four serious cases of unusual blood clots accompanied by low blood platelets, one of which was fatal, came after immunization with the J&J shot, the European Medicines Agency said on Friday. The regulator is now examining the potential safety issues for two Covid vaccines, after AstraZeneca Plc was possibly linked to a rare blood clotting disorder.
J&J is working with regulators to assess data on rare clots and “currently no clear causal relationship has been established” with the vaccine, the company said in an email. Shares traded up to 1.6% lower.
One of the cases that followed the vaccinations against J&J happened during a clinical study. At the time, the company said it had found no evidence that the vaccine was to blame. Three others took place in the United States, where nearly 5 million people were shot dead.
Although the J&J vaccine is approved in the EU, its bulk launch is not expected to start until later this month. However, the EU is relying on the single vaccine to boost its immunization boost amid restrictions in some countries on the use of the AstraZeneca shot, which requires two doses.
Date Sputnik
The EU regulator has also begun a review to assess five reported cases of a rare disorder called capillary leak syndrome in people who have been shot with AstraZeneca. The EMA said it was unclear whether the vaccine was linked to the disorder, in which fluid leaking from the blood vessels causes the tissues to swell and lower blood pressure.
Separately, the EU regulator said it does not yet have enough evidence to approve the Russian Sputnik V vaccine.
J&J, Astra and Sputnik photos all use an adenovirus – the cause of common colds – to release the coronavirus antigen and generate an immune response.
Adenovirus 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, photos from J&J, Sputnik and Chinese doctor CanSino Biologics Inc. be in danger, said Sam Fazeli, an analyst at Bloomberg Intelligence.
The Food and Drug Administration did not immediately respond to a request for comment.
Coagulation cases
The number of cases of clots in people who took the J&J shot has been low so far compared to the total number of people who have received the vaccine worldwide, said Peter Arlett, head of the EMA analysis, on April 7. At the time, Arlett said three coagulations had been found, while about 4.5 million people had been shot by J&J.
“I think it would be fair to say that there is intensive monitoring of this issue in vaccines,” Arlett said.
The EMA will continue its ongoing review of the Russian vaccine until it has enough evidence to support an application for marketing authorization, the agency said on Friday. The EMA declined to comment on the safety information for Sputnik before its assessment was completed.