No products in the cart.
BioNTech / Pfizer and Moderna’s mRNA vaccines may have been linked to rare cases of heart inflammation, according to a post-vaccination analysis of 321 cases released by the European Medicines Agency on Friday.
Myocarditis and pericarditis are inflammatory diseases of the heart with symptoms such as shortness of breath, palpitations, and chest pain.
The PRAC Safety Committee analyzed 145 cases of myocarditis and 138 cases of pericarditis after the BioNTech / Pfizer vaccine. For Moderna’s vaccination, the PRAC analyzed 19 cases of each disease.
By the end of May, around 177 million doses of the BioNTech / Pfizer vaccine and 20 million doses of Moderna had been administered in the European Economic Area.
The PRAC recommended that the product information be updated to include this side effect and raise awareness among health workers and vaccine recipients.
The committee also recommended restricting the approval of the Johnson & Johnson vaccine so that people with a history of capillary leak syndrome would not receive it. It was recommended to add a side effects warning for the serious medical condition where fluid leaks from small blood vessels, causing swelling, low blood pressure, thickening of the blood, and low levels of albumin in the blood.
Three of these cases were reported to the EMA, one in a person with a history of the syndrome after the Johnson & Johnson vaccination. All cases occurred within two days of vaccination; two of the three died. As of June 21, 18 million doses of the single vaccine had been administered worldwide.
Finally, the PRAC noted that the product information for the Oxford / AstraZeneca vaccine included a warning to alert to cases of Guillain-Barre syndrome (GBS) that may have been reported after vaccination.
The syndrome causes nerve inflammation and can lead to pain, numbness, muscle weakness, and difficulty walking.
Currently, “the available data neither confirm nor rule out a possible association with the vaccine,” the PRAC said. However, given the seriousness of GBS, it was advisable to warn people about cases.
This article is part of POLITICS‘s Premium Policy Service: Pro Health Care. Whether drug prices, EMA, vaccines, pharmaceuticals and more – our specialist journalists keep you up to date on health policy issues. E-mail [email protected] for a free trial.