FDA delays review of Moderna COVD jab in adolescents

The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to 17, as it looks at data on heart inflammation in people receiving the shot.

The decision leaves Moderna playing catch-up with Pfizer and BioNTech, whose Comirnaty vaccine was approved for the 12 to 17 age group in May and on Friday also got a green light from the FDA for children aged five to 11.

Moderna said in a statement that it was told by the FDA that the agency “requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination.”

It also said it would delay filing for younger children aged six to 11 until the FDA completes its review.

Both the mRNA vaccines have been linked to cases of myocarditis and pericarditis – forms of heart inflammation – particularly in younger male recipients, but so far the benefits of vaccination and protection against COVID-19 has outweighed those risks in regulatory deliberations.

Moderna said it understands that it could take until January 2022 to complete the review, adding that it is “fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.”

The company added that 1.5 million adolescents have already received mRNA-1273, and according to its calculations the observed rate of myocarditis does not suggest an increased risk in this age bracket.

However, it also acknowledged that it does not have access to data from some recent international analyses.

The delay comes as the US is on the brink of a major expansion of its COVID-19 vaccination drive, with senior figures suggesting that widespread dosing of school-age children could help to reduce circulation of SARS-CoV-2.

As of 21 October, nearly 6.3 million children in the US had tested positive for COVID-19 since the onset of the pandemic, with 118,000 new cases in the previous week and more than a million in the preceding month, according to the American Academy of Paediatrics (AAP).

Acting FDA commissioner Janet Woodcock said on the approval of Comirnaty for five to 11s that “vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.”

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