A Food and Drug Administration committee meets in mid-June to review data on COVID-19 vaccines for children six months to five years old, the agency announced Monday. If all goes as expected, it can sign on shots for that age group within a few days of the meeting.
The announcement came right after Pfizer / BioNTech said in a press release Monday morning that three doses of their COVID-19 vaccine elicited a strong immune response in children between six months and five years of age. They plan to submit the data to the Food and Drug Administration this week.
A preliminary analysis of data from the clinical trial with 1,678 children also showed that the shots were about 80 percent effective in preventing symptomatic COVID-19 infections, according to the press release, but it was only based on a small number of cases.
The intake for this age group is one tenth of the dose of the Pfizer / BioNTech adult vaccines. The companies had originally tested two shots of the lower strength vaccine in children in this age group, but data released on the end of 2021 showed that two shots did not generate a strong immune response in that group. The companies then added a third shot to their lawsuit. The FDA initially indicated that it would review the vaccine for children under the age of five before the full data were available, but it went back in early February – a setback for parents eager to get their young children vaccinated.
Modern asked the FDA to approve its vaccine for children aged six months to six years in March. It uses a quarter of the dosage as the adult shots, and the company said two shots were enough for an immune response comparable to that in adults. The FDA will review Moderna’s data together with Pfizer / BioNTech’s data at the June meeting.
It has been a long wait for parents of children in the age group who are the last to be eligible for the life-saving shots. The wait was made even more anxious by the omicron variant-driven increases in COVID-19 cases in the US, which set record numbers of children under five in the hospital.
“We know parents are eager to determine if these vaccines are safe and effective,” the FDA said. tweeted Monday. “We are working as quickly as possible to carefully review all data.”