FDA says Pfizer COVID vaccine looks effective for young kids

Advisers to the FDA will publicly debate the evidence next week
Virus Outbreak Children Vaccines
NEW YORK, NEW YORK - OCTOBER 03: In this photo illustration, a medical syringe and vials of the Pfizer US pharmaceutical corporation and BioNTech German biotechnology 2021 company logos are seen on October 03, 2021 in New York City. Pfizer and BioNTech announced its conclude phase 3 study of COVID-19 vaccine candidate with 95% primary efficacy analysis, as the media reported on 18 November 2020. Photo credit Getty Images

Federal health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the U.S. weighs beginning vaccinations in youngsters.

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.

If the FDA authorizes the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month -- with the first youngsters in line fully protected by Christmas.

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 w