FDA Postpones Decision on Pfizer COVID-19 Vaccine for Under 5s

The U.S. Food and Drug Administration announced Friday that it will postpone an advisory panel meeting that was slated for next week to weigh the Pfizer COVID-19 vaccine for use in young children.

The FDA took the step after Pfizer notified the agency that it would like to wait until data are available on a three-dose regimen for children aged 6 months to 4 years old, Pfizer said in a statement.

The FDA had planned to review a two-dose regimen at a Feb. 15 meeting of its Vaccines and Related Biological Products Advisory Committee meeting. This committee provides crucial reviews of the data behind vaccine applications.

The application now "will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," Pfizer said. "This is also supported by recent observations of three-dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real-world vaccine protection for omicron compared to the two-dose regimen."

During a media briefing on the postponement, FDA officials explained their change in strategy.

"Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company Pfizer provide us with initial data on two doses from its ongoing study," said Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research. "The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group. The [new] 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 a determination that we could proceed with doing an authorization."