Moderna says FDA needs more time to review its vaccine for teens
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ModernaThe Food and Drug Administration may take longer to assess the Covid-19 vaccine for children 12-17 years old from the biotech firm.
Moderna stated that the agency will be focusing on the possibility of myocarditis among children. The review could not conclude before 2022. Myocarditis is the inflammation of the heart muscle.
Moderna stated that the company was fully committed to supporting FDA’s review, and thanked the FDA for their hard work.
Moderna stated that it will not file a request for an emergency use authorization to a lesser dose of the vaccine in order for the FDA’s review.
Moderna said on May 25 its Covid vaccine was 100% effective in a study of 12-to-17-year-olds. In June, the company applied for an emergency vaccine to be used in adolescents.
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