The US Food and Drug Administration (FDA) will need more time to complete its evaluation of Moderna’s Covid-19 vaccine for adolescents ages 12 to 17, the pharmaceutical major said in a statement on Sunday.
The FDA informed Moderna earlier this week that the review could not be completed before January 2022, the company said. This is a major blow to the timing of the Emergency Use Authorization (EUA) for a COVID vaccine intended for younger age groups.
The US biotech company said it was told late Friday that the FDA needed additional time to evaluate recent international analyzes of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that occurs mainly in young people. affects men.
Moderna said it is conducting its review of new external analyzes on the increased risk of myocarditis in people under the age of 18, as they become available.
Moderna applied in June for US authorization of its Covid-19 shot for 12- to 17-year-olds.
Americans of those ages are eligible for a similar Covid-19 vaccine from Pfizer Inc. and partner BioNTech SE 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 request for the EUA for a 50 microgram dose, the half-strength 50 microgram of the vaccine, for children ages 6 to 11 while the FDA completes a review of filings 12-17.
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