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Calls grow for FDA to speed authorization of kid Covid-19 vaccines

1 32 43
07.09.2021

Pressure is mounting on the Food and Drug Administration to authorize Covid-19 vaccines for children under 12 — even though the data needed to support the move is still being collected.

Politicians have joined anxious parents and some public health groups in calling on federal regulators to accelerate their process for authorizing shots for the youngest Americans. They point to a record number of infections among this age group in recent weeks as schools have reopened. These adults want FDA to expedite its review of data from clinical trials in children, especially now that FDA has fully licensed the Pfizer-BioNTech shot for people 16 and older.

“Getting our children vaccinated is critical to giving parents greater peace of mind, but we are being told approval is still months away,” Maryland Gov. Larry Hogan, a Republican, said in a statement late last month urging speedy sign-off on shots for children ages 5 to 11. Others who have asked for a faster timeline include the American Academy of Pediatrics and several members of Congress from both parties.

But those calls are running up against the FDA’s caution and — crucially — a lack of safety and efficacy data. Regulators have already asked vaccine makers to increase the size of their pediatric clinical trials to increase the chances of detecting rare side effects. The first results from one of those studies, Pfizer’s, are not expected until later this month. And top federal health officials have said they don’t expect a vaccine will be available for 5-to-11-year-olds until late fall or winter. Authorization for children as young as six months will come even later.

With cold weather approaching in much of the country, many parents and public health experts see a recipe for disaster. The change in seasons is likely to send more people indoors at a time when the highly contagious Delta variant is circulating and many cities and states have loosened or discarded public health mandates on mask wearing and social distancing.

“While children are at a low risk, thankfully, compared to our adults, they aren’t at no risk — meaning that we are seeing children in the........

© Politico


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