Agency said on Friday it needs more time to assess emerging international data on whether the vaccine increases the risk for myocarditis
MONDAY, Nov. 1, 2021 (HealthDay News) — The U.S. Food and Drug Administration has delayed a decision on whether to approve emergency use of the Moderna COVID-19 vaccine in 12- to 17-year-olds until at least January, the company announced Sunday.
That is because the agency told the company on Friday that it needs more time to assess emerging international data on whether the vaccine increases the risk for myocarditis, Moderna said in a statement.
“On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA notified Moderna that this review may not be completed before January 2022,” the company said. “The safety of vaccine recipients is of paramount importance to Moderna. The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.”
Several countries have raised concerns that the Moderna vaccine increases the risk of myocarditis in men aged 18 to 30 years, and officials in Finland and Sweden have recommended against the use of Moderna for men younger than 30 years, The Washington Post reported. But Moderna said Sunday that the “U.S. Centers for Disease Control and Prevention and the World Health Organization have stated that myocarditis following vaccination with mRNA vaccines has been rare and generally mild.”
The Moderna vaccine is authorized in the United States for people 18 years and older, and the company asked the FDA in June to authorize it for adolescents. On Sunday, the company also said it will delay seeking FDA authorization of its vaccine for children ages 6 to 11 years.
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