FDA says Pfizer COVID vaccine looks effective for young kids

By LAURAN NEERGAARD and MATTHEW PERRONE

Federal wellness regulators said precocious Friday that kid-size doses of Pfizer’s COVID-19 vaccine look highly effectual astatine preventing symptomatic infections successful simple schoolhouse children and caused nary unexpected information issues, arsenic the U.S. weighs opening vaccinations successful youngsters.

The Food and Drug Administration posted its investigation of Pfizer’s information up of a nationalist gathering adjacent week to statement whether the shots are acceptable for the nation’s astir 28 cardinal children ages 5 to 11. The bureau volition inquire a sheet of extracurricular vaccine experts to ballot connected that question.

In their analysis, FDA scientists concluded that successful astir each script the vaccine’s payment for preventing hospitalizations and decease from COVID-19 would outweigh immoderate superior imaginable broadside effects successful children. But bureau reviewers stopped abbreviated of calling for Pfizer’s changeable to beryllium authorized.

The bureau volition enactment that question to its sheet of autarkic advisers adjacent Tuesday and measurement their proposal earlier making its ain decision.

If the FDA authorizes the shots, the Centers for Disease Control and Prevention volition marque further recommendations connected who should person them the archetypal week of November. Children could statesman vaccinations aboriginal adjacent period — with the archetypal youngsters successful enactment afloat protected by Christmas.

Full-strength Pfizer shots already are recommended for anyone 12 oregon older, but pediatricians and galore parents are anxiously awaiting extortion for younger children to stem infections from the extra-contagious delta variant and assistance support kids successful school.

The FDA reappraisal affirmed results from Pfizer posted earlier successful the time showing the two-dose changeable was astir 91% effectual astatine preventing symptomatic corruption successful young children. Researchers calculated the fig based connected 16 COVID-19 cases successful youngsters fixed dummy shots versus 3 cases among vaccinated children. There were nary terrible illnesses reported among immoderate of the youngsters, but the vaccinated ones had overmuch milder symptoms than their unvaccinated counterparts.

Most of the survey information was collected successful the U.S. during August and September, erstwhile the delta variant had go the ascendant COVID-19 strain.

The FDA reappraisal recovered nary caller oregon unexpected broadside effects, which mostly consisted of sore arms, fever oregon achiness that teens experience.

However, FDA scientists noted that the survey wasn’t ample capable to observe highly uncommon broadside effects, including myocarditis, a benignant of bosom inflammation that occasionally occurs aft the 2nd dose.

The bureau utilized statistical modeling to effort to foretell however galore hospitalizations and deaths from COVID-19 the vaccine would forestall versus the fig of imaginable bosom broadside effects it mightiness cause. In 4 scenarios of the pandemic, the vaccine intelligibly prevented much hospitalizations than would beryllium expected from the bosom broadside effect. Only erstwhile microorganism cases were highly debased would the vaccine origin much hospitalizations than it would prevent. But overall, regulators concluded that the vaccine’s protective benefits “would intelligibly outweigh” its risks.

While children tally a little hazard of terrible unwellness oregon decease than older people, COVID-19 has killed much than 630 Americans 18 and under, according to the CDC. Nearly 6.2 cardinal children person been infected with the coronavirus, much than 1.1 cardinal successful the past six weeks arsenic the delta variant surged, the American Academy of Pediatrics says.

The Biden medication has purchased capable kid-size doses — successful peculiar orange-capped vials to separate them from big vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses volition beryllium promptly shipped astir the country, on with kid-size needles.

More than 25,000 pediatricians and superior attraction providers already person signed up to get the shots into small arms.

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AP Medical Writer Lindsey Tanner contributed to this story.

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The Associated Press Health and Science Department receives enactment from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely liable for each content.