The Food and Drug Administration delayed COVID-19 vaccination for children under five, originally scheduled to be administered to youngsters by next week.
The decision to delay the ultra-low, three-dose series comes after the agency said it needed to wait on data on how it impacts the youngest vaccination group. According to Pfizer, that data could come by early April.
FDA’s vaccine chief Dr. Peter Marks said that information “made us realize that we needed to see data from a third dose from the ongoing trial to decide,” and “We take our responsibility for reviewing these vaccines very seriously because we’re parents as well.”
“If we feel something doesn’t meet (our) standard, we can’t go forward,” he said. “Rather than an issue of having anyone question the process, I hope this reassures people that the process has a standard.”
Currently, there are 18 million ineligible children under the age of five.
Pfizer conducted studies that showed the two shots were safe and strong enough to protect babies as young as 6 months old. The findings, which were presented in December, found that the series didn't generate enough immunity for 2- to 4-year-olds and prompted an additional study.
For young children, Pfizer’s vaccine has a dosage of 3 micrograms. For children ages 5 to 11, the dosage is higher, at 10-micrograms.
In mid-December, Pfizer announced it planned to submit data to the FDA during the first half of 2022 if the three-dose study was successful. At that time, Pfizer said it didn’t identify any safety concerns with the dosage for children ages 6 months to 4 years, which is much lower than the 30-microgram dose for adults.
Upon Pfizer's completion of the analysis in early April, the FDA and other health authorities had several weeks to review and publicly vet the data.
The FDA was expected to publish an analysis of the Pfizer data on Feb.11, ahead of an advisory committee meeting next week but the meeting was postponed.
