Pediatrics group urges FDA OK of COVID-19 vaccines in younger kids

The American Academy of Pediatrics is urging the FDA to quickly expand authorization of COVID-19 vaccines to younger age groups, citing rising cases due to the fast spreading delta variant and risk of poor outcomes following infection.

Pfizer has said it intends to request emergency approval for use of its vaccine in kids aged 5 to 11 by the end of September, with plans to submit data on younger kids aged 6 months to 5 years "shortly thereafter." The FDA had requested drugmakers behind authorized COVID-19 vaccines broaden the size of pediatric clinical trials to better detect for rare adverse events. Moderna previously told Fox News that it expects "to have a package that supports authorization in winter 2021/early 2022" for kids under 12. Reports have noted agency officials intend to see the first shots in kids under 12 by winter or early 2022. Beers, however, argued the original trial size offered enough safety and efficacy data for the FDA to weigh a decision on expanded authorization.