(Reuters) – Modern Inc. said Sunday that it has been said that the U.S. Food and Drug Administration will need additional time to complete an evaluation of the company’s COVID-19 vaccine for use in adolescents aged 12 to 17 years.
The FDA has informed Modern that the review may not be completed before January 2022, the company said in a statement addressing a possible delay in the emergency permit authorization (EUA) for this age group.
Moderna CEO Stephane Bancel 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 the vaccine would be approved for those 12 to 17 years old in the next few weeks.
The U.S. biotech company said it was told late Friday that the FDA needs extra time to assess recent international risk analyzes for a type of heart inflammation called myocarditis, after vaccination, a rare side effect that mainly affects young men.
Moderna has announced that it is conducting its own review of new external analyzes on the increased risk of myocarditis in children under 18 when they become available.
In June, Moderna applied for a U.S. shooting permit for people ages 12 to 17.
Americans of this age are eligible for a similar vaccine against COVID-19 from Pfizer Inc and partner BioNTech SE after it was approved by the FDA and disease control and prevention centers in May.
Moderna also said it would postpone filing a request for an EUA for half the strength of a 50-microgram dose of the vaccine for children ages 6 to 11, while the FDA will complete a review of the application for ages 12 to 17.
(Reported by Sneha Bhowmik of Bengaluru; edited by Bill Berkrot)