The American Academy of Pediatrics is urging the FDA to quickly expand authorization ofto younger age groups, citing rising cases due to the fast spreading delta variant and risk of poor outcomes following infection.
“We need to be approaching the trials and authorization of the COVID vaccine for children with the same urgency that we did with adults,” Dr. Lee Savio Beers, president of the AAP, told ABC co-hosts. “Just as it’s a serious disease in adults, it can be a very serious disease in children.”
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.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.
“When our experts looked at the data, they really felt very comfortable that the original trial size, the way the trial was set up originally, is really adequate to be able to assess the safety and efficacy of the vaccine,” Beers told ABC.
“The process that the FDA goes through to review and approve vaccines for adults and children is very cautious, very thorough as it should be, and I think what our experts have said and weighed in on is that they really feel like the data is there, will be there very soon or perhaps there now where the FDA can really look at that data for kids and make a determination if the vaccine is safe and effective for them, and if so, to move it forward to authorization,” she continued.
Beers said kids can safely return to in-person classes through layered precautions like universal masking, hand washing, physical distancing, vaccinations among eligible groups and access to testing. Growing numbers of pediatrichave stirred alarm as respiratory illnesses coincide and younger children remain ineligible to receive amid the start of the school year.
However, experts say it’s unclear whether the delta variant inflicts more severe disease in children.
“We’re still learning about it,” Beers said. “We absolutely are seeing increases in number of cases,” citing a near doubling in pediatric COVID-19 cases in past two weeks.