FDA Puts hold on approving COVID Vaccine for Toddlers

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Fri, 2022-02-11 16:39 — mike kraft

FDA Puts COVID Vaccine for Toddlers in Timeout Agency attributes sudden decision to needing more data on third dose Molly Walker medpagetoday

The 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. ...

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