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J&J COVID vaccine revised by EU regulator after blood clots

The European Union’s Drug Enforcement Administration has announced that it has launched a review to assess the blood clot of people who have received the COVID-19 vaccine.

The European Medicines Agency said on Friday that four serious cases of abnormal thrombosis accompanied by blood platelets, one of which was fatal, were found after vaccination. This step regulates the safety check of the regulator on the second shot of COVID after the AstraZeneca Plc vaccine may have been associated with a rare blood clotting disorder.

One of the cases following the J&J vaccination occurred during a clinical trial. The company said at the time that it had found no evidence that the vaccine was harmful. Three more took place in the United States, where nearly 5 million people were shot.

Although the J&J vaccine is approved in the EU, its distribution in the bloc is not expected to start later this month. The EU is still relying on a single-dose vaccine to boost its immunization engine, in some countries amid restrictions on the use of AstraZeneca shot in two doses.

A separate regulator said it did not yet have enough evidence to support the Russian Sputnik V vaccine.

J&J representatives did not immediately respond to a request for comment. The pharmacist’s vaccine uses both AstraZeneca shot and Sputnik-like technology.

The Food and Drug Administration did not immediately respond to a request for comment.

The number of people with thrombosis in J&J staff is still small compared to the total number of people receiving the vaccine worldwide, Peter Arlett, head of EMA analysis, said on April 7. At that moment, Arlett said that there were three condensations. The cases were discovered before 4.5 million people received J&J staff.

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“I think it would be fair to say that there is intensive monitoring of this problem among vaccines,” Arlett said.

Like J&J և Astra personnel, Sputnik uses chimpanzee adenovirus to transmit coronavirus antigen, which causes some common colds, to trigger an immune response.

The EMA will continue to review Russian vaccines until it has enough evidence to approve the marketing authorization application, the agency said on Friday. The EMA declined to comment on Sputnik’s security information before completing its assessment.



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