The European Union drug regulator said it is reviewing the risk of an inflammatory body disease in relation to the Pfizer-BioNTech COVID-19 vaccine.
The safety panel of the European Medicines Agency is examining a report from a 17-year-old teenage man from Denmark who has developed multisystem inflammatory syndrome (MIS). The teen has fully recovered, the agency said, adding that the condition was reported after other vaccines against COVID-19.
“GIS is rare and its estimated incidence rate before the estimated COVID-19 pandemic in five European countries was between 2 and 6 cases per 100,000 per year in children and adolescents under 20 and under 2 cases per 100,000 per year in adults aged 20 years or older, “the regulator said in a statement.” At this stage, there are no changes in the current EU recommendations for the use of COVID- vaccines. 19 “.
The disease was previously reported in people following a non-vaccine-related COVID-19 infection, according to the health agency. But the 17-year-old Dane did not have such a medical history.
“It is important to understand that a thorough GIS assessment is underway and it has not been concluded that COVID-19 mRNA vaccines cause MIS,” a Pfizer spokesman told Reuters. The Epoch Times has contacted the company to comment.
Five cases of MIS were reported in the European Economic Area on August 19 after the Pfizer vaccine, while one case was reported with each Johnson & Johnson and Moderna vaccine, the European regulator said.
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 approval in the United States last month.
The European safety committee said it is investigating cases of blood clots in the veins, known as venous thromboembolism, in connection with the Johnson & Johnson shooting.
“Venous thromboembolism was included in the risk management plan for the COVID-19 Janssen vaccine as a safety issue to be investigated, based on a higher proportion of cases of venous thromboembolism observed within the vaccinated group compared to the placebo group in the first clinical studies authorized this vaccine, “according to the European Medicines Agency.
COVID-19 is the disease caused by the PCC (Chinese Communist Party) virus.
MIS, meanwhile, is a newly coined medical condition associated with the virus, according to the U.S. Centers for Disease Control and Prevention. It was first called pediatric multisystem inflammatory syndrome and shared symptoms similar to Kawasaki disease and toxic shock syndrome.
Reuters contributed to this report.
Jack Phillips
Senior Reporter
Jack Phillips is a journalist at The Epoch Times based in New York.