Federal 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, causing no unexpected safety issues.
The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting coming next week on debating whether the shots are ready for the nation’s roughly 28 million children ages 5 to ll. A panel of outside vaccine experts will be asked to vote on that question by the agency.
FDA scientists concluded that the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children in almost every scenario in their analysis. Agency reviewers however stopped short of calling Pfizer’s shot to be authorized. That question will be put to its panel of independent advisers next Tuesday, weighing 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. Vaccination for children could begin early next month.
Full-strength Pfizer shots are already recommended for anyone 12 or older, but pediatricians and many parents anxiously await protections for younger children to stem infections from the extra-contagious delta variant.
Affirming the Pfizer results posted earlier in the day, the FDA review showed that the two-dose shot was nearly 91% effective at preventing symptomatic infection in young children. The figure was calculated based on 16 COVID-19 cases in youngsters given dummy shots versus three in vaccinated children. There were no severe illnesses reported among any of the youngsters, but vaccinated children had much milder symptoms than their unvaccinated counterparts.
The majority of the study data was collected in the US during August and September when the delta variant had become the dominant COVID-19 strain.
No new or unexpected side effects were found by the FDA review. Most of the ones that did occur consisted of sore arms, fever, or achiness.