The US Food and Drug Administration is delaying approval of Moderna Inc.’s (NASDAQ: MRNA) Covid-19 vaccination for adolescents in order to see if the injection increases the risk of rare inflammatory heart disease, according to people familiar with the issue.
FDA investigating Moderna’s risk of myocarditis among teenagers
The FDA has been looking into the risk of myocarditis among younger men who took Moderna’s vaccine, especially compared to those who received the vaccine from Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) after four Nordic countries affirmed their stances against giving Moderna vaccines to younger adults last week.
According to the sources, regulators have yet to decide whether there is a heightened risk. The delay could last many weeks, but the exact timing is unknown. The FDA will further review data regarding the vaccine before maki9ng a decision on extending the eligibility of the vaccine to teenagers.
Parents looking to vaccine adolescents still have access to Pfizer’s vaccine. However, the approval delay could put off some parents that have held off vaccinating young adults because of safety concerns. The agency’s caution could ease the minds of the hesitant parents. Depending on the FDA’s decision, Pfizer could be the only preferred vaccine for adolescents and kids in the US.
Myocarditis risk with mRNA vaccine is low
Moderna Chief Medical Officer Paul Burton said, “I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products.”
The company’s CEO, Stephane Bancel, said in an interview that the benefits of the Moderna vaccine include long-lasting and string protection outweighing the risks.
Bancel said, “Some countries want to be ultraconservative, it’s of course their prerogative, but with the data I’ve seen I would be comfortable with anybody in my family who is a young male getting the vaccine.”