The FDA is weighing in on whether to authorize Pfizer’s COVID-19 vaccine in younger kids

A boy receives the first dose of the Pfizer/BioNTech COVID-19 vaccine in Tegucigalpa, on September 25, 2021, during a vaccination programme for teens aged 12 to 15
The Food and Drug Administration is considering authorizing the Pfizer-BioNTech vaccine for 5- to 11-year-olds. ORLANDO SIERRA / AFP) (Photo by ORLANDO SIERRA/AFP/Getty Images
  • A study found the Pfizer-BioNTech vaccine effective at preventing symptomatic COVID-19 in kids.
  • The study, a Pfizer trial, found 91% efficacy for the jab among more than 2,200 kids ages 5 to 11.
  • The FDA’s expert panel is meeting Tuesday to discuss and vote on Pfizer’s application.

As a critical expert panel vote nears, the FDA says benefits outweigh the risks for Pfizer’s COVID-19 shot in younger kids.

The Pfizer-BioNTech coronavirus vaccine was found to be 91% effective in preventing symptomatic illness in younger children in a study.

The new data was released Friday as the Food and Drug Administration entered its final stages of reviewing Pfizer’s application to offer its shot to 5- to 11-year-olds. Currently, the two-dose vaccine is allowed for use in people ages 12 and older.

The FDA’s expert panel is set to meet Tuesday to discuss and vote on Pfizer’s application.

This is the first look at efficacy data for the Pfizer-BioNTech vaccine in the 5- to 11-year-old age group. Pfizer and BioNTech described immune responses from this study in September but didn’t have enough COVID-19 cases at the time to calculate the vaccine’s efficacy.

The results come from Pfizer’s summary of its data submitted to the FDA. The results have been submitted to a medical journal but have yet to be published.

The FDA also published its own review of Pfizer’s application on Friday night, finding the benefits of the shot for younger children outweighed the risks.

The agency’s positive review sets the stage for an authorization decision in the coming days. The Centers for Disease Control and Prevention’s expert panel is also scheduled to discuss Pfizer’s application on November 2 and 3.

Younger children could start getting vaccinated soon after that meeting, if the FDA and CDC reviews both support the shot.

Vaccinated volunteers had fewer COVID-19 cases, reported fewer symptoms than kids who got placebo shots

Overall, the study tallied 19 COVID-19 cases, with 16 cases among those getting placebo shots and three cases in the vaccinated group.

The trial enrolled 2,268 volunteers, randomly giving two-thirds the Pfizer-BioNTech vaccine and the other third placebo shots. The study’s population was about equally split by gender and was 79% white, 6% Black, 6% Asian, and 21% Hispanic.

While the case numbers are small, the three COVID-19 cases among the vaccinated group were mild with four or fewer symptoms, such as headache, cough, sore throat, and nausea.

COVID-19 cases among the placebo group had more symptoms. Eight of the 16 cases had five or more symptoms. Ten of these kids recorded fevers.

Across both the vaccinated and placebo groups, there were no severe COVID-19 cases or deaths. The most common side effects from the shot were injection-site pain, fatigue, and headache.

In its study in kids ages 5 to 11, Pfizer used a smaller dose than its original vaccine. While older children and adults receive two 30-microgram doses, these younger children were tested with two 10-microgram doses.