(Reuters) – The European Medicines Agency (EMA) said on Friday that it is examining whether there are risks of a rare problem of inflammation after inoculation with Covid-19 vaccines, after reporting a case involving the Pfizer vaccine/ BioNTech.
The EMA safety committee is studying a case of multisystem inflammatory syndrome (MIS) after a 17-year-old young man from Denmark reported the problem, the regulatory agency said.
The teenager has fully recovered. This condition has also been reported after using some other Covid-19 vaccines, he added.
SIM has also been previously reported in people after contracting Covid-19, the agency said. However, the Danish teenager had no history of infection.
The syndrome is a serious but rare condition that causes inflammation in different parts of the body, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.
The regulatory agency said there is currently no change in recommendations on the use of Pfizer’s vaccine, as well as other vaccines.
Pfizer, the Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) did not immediately respond to requests for comment from Reuters.
Meanwhile, the committee also looks at cases of blood clots in the veins, or venous thromboembolism, resulting from the Johnson & Johnson Covid-19 vaccine.
According to the EMA, the issue is distinct from a previously identified rare side effect and was included in J&J’s vaccine risk management plan as a safety issue to be studied.
J&J did not immediately respond to requests for comment from Reuters.
(By Pushkala Aripaka and Manas Mishra in Bengaluru)
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