EU regulators have found a “possible link” between the J & J vaccine and blood clots



European Union drug regulators said Tuesday that there was a “potential link” between Johnson & Johnson’s COVID-19 vaccine and blood clots, but that “overall benefit risk remains positive.” “.

European Medicines Agency (EMA) Safety Commission at a meeting on Tuesday Conclusion It is necessary to add a warning about abnormal blood clots to the product information of the COVID-19 vaccine Janssen developed by Janssen, a subsidiary of Johnson & Johnson.

The Commission said thrombotic events should be listed as “very rare side effects” of the vaccine.

The Commission said it took into account “all currently available evidence,” including eight reports from the United States on serious cases of abnormal blood clots associated with low levels of platelets. One of them had fatal consequences.

All of these cases occurred within 3 weeks of vaccination, most of them female.

The EMA said no “specific risk factors” have been identified based on the available information.

The Safety Commission pointed out that blood clots occur in “almost abnormal areas” such as veins and arteries in the brain and abdomen, have low platelet levels, and can cause bleeding.

One plausible explanation, the Commission said, was “an immune response that leads to heparin-induced thrombocytopenia, a condition similar to that sometimes seen in patients treated with heparin called HIT.”

EMA states that medical professionals and vaccinated people “need to be aware of the possibility of very rare cases of blood clots combined with low levels of platelets that occur within 3 weeks of vaccination.” I did.

However, this case was “very rare” and emphasized that the overall benefit of the vaccine in the prevention of COVID-19 “outweighs the risk of side effects”.

The United States approved Johnson & Johnson shooting last month, with more than 7 million doses as of April 13.

The shot was approved by the European Union on March 11th, but the deployment of the shot has not yet begun.

Another COVID-19 vaccine from UK-based AstraZeneca was previously investigated by the European Medicines Agency following reports of post-vaccination thrombosis.

Authorities concluded on April 7 that there was a “potential link” between the vaccine and the blood clot, but the recommending countries still used jabs and determined that the benefits outweighed the risks. I am.

The EMA said on Tuesday that cases of blood clots associated with the Janssen vaccine were “very similar” to those that occurred after the vaccination of AstraZeneca’s jab.

Zachary Stieber and Jack Philips contributed to this report.