Politicians have joined concerned parents and some public health groups in calling on federal regulators to expedite their process for approving 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 promote 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 pressing speedy sign-off on shots for children ages 5 to 11. Others who have requested a hastier timeline include the American Academy of Pediatrics and several members of Congress from both parties.
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But those requests are moving up against the FDA’s caution and — crucially — a shortage of safety and efficacy data. Regulators have already asked vaccine makers to expand the size of their pediatric clinical trials to enhance the chances of identifying rare side effects. The first results from one of those studies, Pfizer’s, are not scheduled until later this month. And top federal health officials have said they don’t foresee a vaccine will be available for 5-to-11-year-olds until late fall or winter. Approval for children as young as six months will come even later.
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With cold weather advancing in most of the country, many parents and public health experts see a formula 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.
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“While children are at low risk, thankfully, compared to our adults, they aren’t at no risk — meaning that we are seeing children in the hospital. We are hearing of deaths,” said Jason Newland, a pediatric infectious disease professor at Washington University School of Medicine in St. Louis.
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Certainly, hospitalizations among children and teens quadrupled in August in states with low vaccination rates, the Centers for Disease Control and Prevention said in a report released Friday. Hospital admissions for unvaccinated youngsters and for kids 4 and under have each risen tenfold since mid-June when the Delta variant took hold in the U.S., CDC said.
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