FDA Puts COVID Vaccine for Toddlers in Timeout

FDA is postponing their scheduled advisory committee meeting on Pfizer’s COVID-19 vaccine for children ages 6 months to 4 years, which now may not happen for a few more months, agency officials said on Friday.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) was slated to meet on Tuesday, February 15, to discuss Pfizer’s application for their COVID vaccine in this age group. However, an FDA media briefing indicated that it could take months to get the new data needed to go forward.

A statement from FDA noted that Pfizer recently told them about “additional findings from its ongoing clinical trial,” which led the agency to postpone the meeting. As previously reported, a two-dose vaccine series failed to meet immunobridging criteria among the youngest children.

Pfizer itself released a statement, explaining that a third dose “may provide a higher level of protection in this age group,” based on findings from booster dose studies that showed that three doses boosted neutralizing antibody levels and “real-world protection.”

In a hastily arranged media briefing on Friday, Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, noted that the Omicron variant has sickened a large number of children, which compelled the agency to act with urgency. However, they ultimately came to the conclusion that “additional time regarding a third dose should be considered.”

Prior media reports indicated this was all but a done deal, and that the vaccine could be authorized for this age group by President’s Day.

When reporters pressed Marks for details, he explained that “the data that we saw made us realize that we needed to see data from a third dose in the ongoing trial in order to make the determination that we could proceed with doing an authorization.”

Marks added that it was a safe assumption that when the additional data are reviewed, they will be clinical data on infection and not merely immunobridging data.

He promised that FDA would review the data “in an expeditious manner” as it came in.

“For the next few months, while these additional data are gathered, parents will have to rely on what they’ve come to do well,” including the use of masks and ensuring that all other family members are vaccinated, Marks said.