Moderna says FDA wants extra time to finish evaluation of its COVID-19 shot for adolescents By Reuters
© Reuters. FILE PHOTO: An employee shows the Moderna COVID-19 vaccine at Northwell Health’s Long Island Jewish Valley Stream Hospital in New York, the United States, Dec. 21, 2020. REUTERS / Eduardo Munoz / File Photo
(Reuters) – Modern (NASDAQ 🙂 Inc said Sunday that it will take the U.S. Food and Drug Administration additional time to complete its assessment of the company’s COVID-19 vaccine for use in adolescents ages 12-17.
The FDA told Moderna that the review may not be completed before January 2022, the company said in a statement, implying a possible setback for the timing of an Emergency Authorization (EUA) for this age group.
Stephane Bancel, Chief Executive of Moderna, told Reuters last week https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-moderna-covid-19-shot-could-start-being-used-children-teens -within-2021 -10-27 that, based on discussions with the agency, he believed that the vaccine would be approved for 12 to 17 year olds in the next few weeks.
The US biotech company said it was announced late Friday that the FDA would need the additional time to evaluate recent international analysis of the post-vaccination risk of developing a type of heart infection called myocarditis, a rare side effect that is primarily concerned young men.
Moderna said it will conduct its own review of new external analysis of the increased risk of myocarditis in those under the age of 18 as they become available.
Moderna applied for US approval of its inclusion for 12 to 17 year olds in June.
Americans of this age are eligible for the similar COVID-19 vaccine from Pfizer Inc (NYSE 🙂 and partner BioNTech SE (NASDAQ 🙂 after it was approved by the FDA and the Centers for Disease Control and Prevention in May.
Moderna also said it will delay filing its application for an EUA for a 50 microgram dose of the half strength vaccine for children ages 6-11 as the FDA completes its review of the 12-17 filing.
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