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Moderna says FDA needs more time to complete review of its COVID-19 shot for adolescents By Reuters


© Reuters. FILE PHOTO: An worker reveals the Moderna COVID-19 vaccine at Northwell Health’s Long Island Jewish Valley Stream hospital in New York, U.S., December 21, 2020. REUTERS/Eduardo Munoz/File Photo

(Reuters) – Moderna (NASDAQ:) Inc mentioned on Sunday it has been advised that the U.S. Food and Drug Administration would require extra time to complete its evaluation of the corporate’s COVID-19 vaccine for use in adolescents aged 12 to 17 years.

The FDA knowledgeable Moderna that the review is probably not accomplished earlier than January 2022, the corporate mentioned in an announcement, dealing a possible setback to the timing of an emergency use authorization (EUA) for that age group.

Moderna Chief Executive Stephane Bancel advised Reuters final 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 mostly on conversations with the company, he believed the vaccine could be approved for these 12 to 17 within the subsequent few weeks.

The U.S. biotech firm mentioned it was advised late on Friday that the FDA wanted the extra time to consider current worldwide analyses of the danger of a sort of coronary heart irritation referred to as myocarditis after vaccination, a uncommon facet impact that has primarily affected younger males.

Moderna mentioned it’s conducting its personal review of new exterior analyses on the elevated myocarditis threat in these lower than 18 years of age as they turn out to be out there.

Moderna utilized for U.S. authorization of its shot for these aged 12 to 17 in June.

Americans of these ages are eligible for the same COVID-19 vaccine from Pfizer Inc (NYSE:) and companion BioNTech SE (NASDAQ:) after it was cleared by the FDA and Centers for Disease Control and Prevention in May.

Moderna additionally mentioned it’s going to delay submitting its request for an EUA for a half power 50-microgram dose of the vaccine for kids ages 6 to 11 whereas the FDA completes its review of the 12-17 submitting.

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