The European Union’s drug regulator said it is reviewing the risk of a body inflammation condition in connection to the Pfizer-BioNTech COVID-19 vaccine.
“MIS is rare and its incidence rate before the COVID-19 pandemic estimated from five European countries was around 2 to 6 cases per 100,000 per year in children and adolescents below 20 years of age and below 2 cases per 100,000 per year in adults aged 20 years or more,” said the regulator in a statement. “At this stage, there is no change to the current EU recommendations for the use of COVID-19 vaccines.”
The condition was previously reported in people following a COVID-19 infection unrelated to vaccines, according to the health agency. But the Danish 17 year old had no such medical history.
“It is important to understand that a careful assessment of MIS is ongoing, and it has not been concluded that mRNA COVID-19 vaccines cause MIS,” a Pfizer spokesperson told Reuters. The Epoch Times has contacted the company for comment.
Five cases of MIS were reported in the European Economic Area as of Aug. 19 after the Pfizer vaccine, while one case was reported with each Johnson & Johnson’s and Moderna’s vaccine, the European regulator said.
Safety data released by the CDC and Pfizer at a meeting on Monday did not include any incidences of MIS in those who took the vaccine, which was granted full approval in the United States last month.
The European safety panel said it is investigating cases of blood clots in the veins, known as venous thromboembolism, in connection to the Johnson & Johnson shot.
“Venous thromboembolism was included in the risk management plan for COVID-19 Vaccine Janssen as a safety issue to be investigated, based on a higher proportion of cases of venous thromboembolism observed within the vaccinated group versus the placebo group in the first clinical studies used to authorize this vaccine,” according to the European Medicines Agency.
