AMSTERDAM (Reuters) – Europe’s drug regulator said on Friday (September 8th) that it was reviewing the risk of rare inflammatory conditions after being vaccinated with the Covid-1 vaccine following a report in a Pfizer-Biotech shot case.
The safety panel of the European Medicines Agency is investigating Multisystem Inflammatory Syndrome (MIS) after receiving news of the condition of a 17-year-old man in Denmark.
The teenager has recovered completely. The condition has been reported even after some other Covid-1 vaccines have been given, the regulator said.
According to the agency, MIS has been reported in humans even after Covid-1 disease. However, the Danish teenager had no history of infection.
The syndrome is a deadly but rare condition where various parts of the body become swollen, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.
The regulator said there was currently no change in its recommendation for the use of the Pfizer vaccine, as well as other shots.
Five cases of MIS were reported in the European Economic Area as of Aug. 1 after the Pfizer vaccine, with one case each for the J&J and Modern vaccines, the regulator said.
The safety data released by the Centers for Disease Control and Pfizer at a meeting Monday did not include any cases of MIS among vaccine recipients, which received full U.S. approval last month.
Meanwhile, the European Security Panel is also looking into venous blood clots or venous thromboembolism with the Johnson & Johnson vaccine.
The regulator said the problem was different from a rare side effect previously identified and that it was included in J&J’s vaccine risk management plan, which will be studied as a safety issue.
It sees the issue as a separate condition from low platelet blood clots.