A Food and Drug Administration committee will meet in mid-June to review data on COVID-19 vaccines for children six months through five years old, the agency announced Monday. If all goes as expected, it could sign off on the shots for that age group within days of that meeting.
The announcement came just after Pfizer / BioNTech said in a Monday morning press release that three doses of their COVID-19 vaccine produced a strong immune response in children between six months and five years old. They plan to submit the data to the Food and Drug Administration this week.
A preliminary analysis of data from the clinical trial of 1,678 children also showed that the shots were around 80 percent effective at preventing symptomatic COVID-19 infections, according to the press release, but that was based on only a small number of cases.
The shots for this age group are at one-tenth the dose of the Pfizer / BioNTech adult vaccines. The companies had originally tested two shots of that lower-strength vaccine in children in this age group, but data released at the end of 2021 showed that two shots didn’t generate a strong immune response in that group. The companies then added a third shot to their trial. The FDA originally indicated that it would review the vaccine for kids under five before the complete data was available but walked that back in early February — a setback for parents anxious to get their young children vaccinated.
Moderna asked the FDA to authorize its vaccine for children aged six months to six years in March. It uses one-fourth the dosage as the adult shots, and the company said two shots were enough for an immune response comparable to the one in adults. The FDA will review Moderna’s data, along with Pfizer / BioNTech’s data, at the June meeting.
It’s been a long wait for parents of kids in that age group, which is the last to become eligible for the lifesaving shots. The wait was made even more anxious by the omicron variant-fueled surges in COVID-19 cases in the United States, which put record numbers of children under five in the hospital.
“We know parents are anxious for us to determine if these vaccines are safe & effective,” the FDA tweeted Monday. “We are working as quickly as possible to carefully review all the data.”