FDA delays decision on Moderna COVID-19 vaccine for adolescents
Agency to check shot for cardiac side effect
The Food and Drug Administration is delaying a decision on whether to make Moderna’s coronavirus vaccine available to adolescents because the agency needs more time to evaluate if the shot increases the risk of a rare cardiac side effect, the company said Sunday.
Moderna, a Cambridge, Massachusetts, biotechnology company, said in a news release that the FDA indicated it will take until at least January to complete the review of Moderna’s application for use in 12to 17-year- olds.
The agency told the vaccine maker Friday evening it needed more time to analyze emerging international data on the risk of myocarditis, an inflammation of the heart muscle that in rare instances occurs after vaccination.
The agency’s action comes after several countries, including Japan and Nordic nations, raised concerns that the Moderna vaccine increases the risk of myocarditis in men 18 to 30 years old. In Finland and Sweden, authorities have recommended against the use of Moderna for men younger than 30.
Moderna asked the FDA in June to authorize its vaccine for adolescents. The shot is authorized for people 18 and older.
The proposed vaccine regimen for adolescents is the same as that for adults — two 100-microgram shots, given 28 days apart.
The company also said Sunday it will delay asking the FDA for authorization of its vaccine for children 6 to 11 years old. That age group would receive two shots of a half dose of 50 micrograms.
The Moderna delays are occurring as Pfizer and its German partner, BioNTech, make rapid inroads with their vaccine into younger age groups.
The FDA last spring authorized the Pfizer-BioNTech vaccine for adolescents 12 to 15 years old. And on Friday, the agency cleared the vaccine for children 5 to 11, administered in two shots of 10 micrograms. That dose is one-third the adolescent and adult dose.
The vaccine is expected to be available for younger children this week, following a review by immunization advisers to the Centers for Disease Control and Prevention and likely recommendation by CDC Director Rochelle Walensky.
In its statement, Moderna said “the safety of vaccine recipients is of paramount importance” and that the company is working closely with the FDA.