EU reviewing risk of rare inflammation after COVID-19 vaccines

September 3 (Reuters) – European drug regulator said on Friday it was reviewing whether COVID-19 vaccines caused the risk of a rare inflammatory disease, following a case report with Pfizer / BioNTech’s (PFE). N), (22UAy.DE) tir.

The safety panel of the European Medicines Agency is studying the multisystem inflammatory syndrome (MIS) after the disease was reported in a 17-year-old man in Denmark, according to the agency.

The teenager has fully recovered. The disease has also been reported after other vaccines against COVID-19, the regulator said.

MIS has also been reported in people following COVID-19 infection, the agency said. However, the Danish teenager did not have this story.

The syndrome is a serious but rare condition in which different parts of the body become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.

In its response, Pfizer said it thoroughly reviews all possible adverse events, along with regulatory authorities.

“It is important to understand that a careful GIS assessment is maintained and it has not been concluded that COVID-19 mRNA vaccines cause GIS,” a Pfizer spokesman said.

The European regulator said there was currently no change in its recommendations for the use of the Pfizer vaccine as well as other traits.

The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) did not immediately respond to Reuters’ requests for comment.

On 19 August, following the Pfizer vaccine, five cases of MIS were reported in the European Economic Area, while one case was reported with each Johnson & Johnson (JNJ.N) and Modern (MRNA) vaccine. .O), said the regulator.

Safety data released by CDC and Pfizer at a meeting Monday did not include any incidence of MIS in those who took the vaccine, which received full U.S. approval last month.

Meanwhile, the European safety panel is also studying cases of blood clots in the veins or venous thromboembolism, with the J&J vaccine.

J&J did not immediately respond to Reuters’ request for comment.

Reports of Pushkala Aripaka and Manas Mishra in Bengaluru, additional reports of Ankur Banerjee; Edited by Ramakrishnan M. and Arun Koyyur

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