Moderna says FDA needs more time to complete review of Covid jab for adolescents


The US Food and Drug Administration (FDA) will need more time to complete its assessment of the Moderna's Covid-19 vaccine for adolescents aged 12 to 17 years, the pharmaceutical major said in a statement on Sunday.

The FDA informed Moderna earlier this week that the review may not be completed before January 2022, the company said. This is a major setback to the timing of an emergency use authorization (EUA) for the Covid vaccine meant for younger age groups.

The US biotech company said it was told late on Friday that the FDA needed the additional time to evaluate recent international analyses of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that has primarily affected young males.

Moderna said it is conducting its own review of new external analyses on the increased myocarditis risk in those less than 18 years of age as they become available.

Moderna had applied for US authorisation of its Covid-19 shot for 12- to 17- year olds in June.

Americans of those ages are eligible for the similar Covid-19 vaccine from Pfizer Inc and partner BioNTech SE after it was cleared by the FDA and Centers for Disease Control and Prevention in May.

Moderna also said it will delay filing its request for an EUA for a half strength 50-microgram dose of the vaccine for children ages 6 to 11 while the FDA completes its review of the 12-17 filing.

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