The Food and Drug Administration is reviewing reports suggesting that the coronavirus vaccine made by Moderna may cause heart problems in some adolescents. the company said Sunday.
Moderna sought approval from the FDA in June for its vaccine to be used in children aged 12-17. Adolescents would receive 100 micrograms of the vaccine – the same dose given to adults 18 years and older. However, the agency has yet to make a decision on the application, leading to speculation about the reasons for the delay.
Inside statement on sundayModerna said the FDA “needs additional time to evaluate recent international analyzes of myocarditis risk after vaccination.”
The European Medicines Agency approved the vaccine for use in adolescents in July. But since then, several European countries paused the use of the vaccine Expressing concern about myocarditis, an inflammation of the heart muscle, in people 30 years of age and younger.
Moderna said more than 1.5 million adolescents worldwide have received the coronavirus vaccine, and data so far have not shown an increased risk of myocarditis. However, studies from Israel and the US have found both Pfizer-BioNTech and Moderna vaccines. Rare and transient cases Myocarditis with a higher risk than the Moderna vaccine.
The company said on Sunday that the FDA told Moderna on Friday that it needed more time to evaluate the safety of the vaccine and may not make a decision until January 2022. The agency took about a month Confirm the Pfizer-BioNTech vaccine For children aged 12 to 15 years. This vaccine has been available for adolescents in the United States and Europe since May.
As director of the Philadelphia Children’s Hospital Vaccine Education Center and a member of the FDA’s vaccine advisory committee, Dr. Despite the increased risk, myocarditis as a result of the vaccine is rare, mild and resolves quickly, said Paul Offit.
Dr. Offit stated that Covid-19 is much more likely to cause myocarditis because the virus can infect and damage the lining of the heart. “That would be the decision point I would make for my child,” she said.
In studies conducted in Israel and the United States, the incidence of heart problems in people who receive the Pfizer-BioNTech or Moderna vaccine is highest in men ages 16 to 29. Dr. Offit said the risk decreases in children aged 12-15 and is expected to be even lower in younger children.
In July, the FDA from Pfizer-BioNTech and Moderna register more children In clinical trials to detect less common side effects. Last week, after reviewing data from a clinical trial of the Pfizer-BioNTech vaccine in children ages 5 to 11, the FDA granted approval for the vaccine for that age group.
Results from Pfizer’s vaccine trial in children under the age of 5 are not expected to be available until the fourth quarter of this year at the earliest. Last week, Moderna announced that its vaccine strong immune response in children aged 6 to 11 years who receive half the adult dose. The company plans to seek approval from the FDA for use of the vaccine in this age group.