EU Investigates Rare Inflammation After COVID-19 Vaccination

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JAKARTA - European drug regulators said on Friday they would examine whether a COVID-19 vaccine poses a rare risk of inflammation, following reports of one case in Pfizer/BioNTech vaccine injections.

The European Medicines Agency (EMA) safety panel is examining Multisystem Inflammatory Syndrome (MIS) after the condition was reported in a 17-year-old Danish boy, the EMA said. The teenager has fully recovered.

The condition has also been reported in some people after receiving the COVID-19 vaccine, the agency said.

Cited from Antara, Saturday, September 4, MIS has also previously been reported in people infected with COVID-19, the EMA said. However, the Danish teenager had no history of infection.

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

In its response, Pfizer admitted to reviewing all possible side effects thoroughly with the authorities.

"It is important to understand that a careful examination of MIS is underway and it has not been concluded that an mRNA-based COVID-19 vaccine causes MIS", a Pfizer spokesperson said.

​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​there are no changes in their recommendation for the use of Pfizer and other vaccines.

The US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) did not immediately respond to requests for comment.

Five cases of MIS after being injected with the Pfizer vaccine were reported in the European Economic Area through August 19, while one case was reported after the Johnson & Johnson vaccine and the Moderna vaccine, the EMA said.

Safety data released by the CDC and Pfizer at Monday's meeting did not cover the incidence of MIS in those who received the vaccine injection. Pfizer's vaccine received full clearance from the US last month.

Meanwhile, the European safety panel is also examining cases of blood clots in the veins (venous thromboembolism) after the J&J vaccine injection.

J&J has not commented on the case.