FDA says Pfizer COVID vaccine looks effective for young kids

1 month ago 21

Federal scientists say kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections among elementary school children

October 23, 2021, 2:32 AM

3 min read

The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question.

In their analysis, FDA scientists concluded that in almost every scenario the vaccine's benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer's shot to be authorized.

The agency will put that question to its panel of independent advisers next Tuesday and weigh their advice before making its own decision.

Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.

The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91% effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.

The FDA review found no new or unexpected side effects, which mostly consisted of sore arms, fever or achiness that teens experience.

However, FDA scientists noted that the study wasn't large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose. The agency used statistical modeling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. Overall, regulators concluded that the vaccine's protective benefits “would clearly outweigh" cases of the heart side effect.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little 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 support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.


ABC News


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