The U.S. government and Pfizer reached an agreement to delay the U.S. regulatory decision on the company’s COVID-19 vaccine for children as young as 6 months old, Pfizer’s CEO said on March 13.
“We all agreed it’s better if we wait for the three doses to come out,” CEO Albert Bourla said on CBS’ “Face the Nation.”
Pfizer and its partner BioNTech have been testing their vaccine on children aged 6 months to 4 years but announced in late 2021 that they were expanding the clinical trial to three doses because the two-dose primary regimen didn’t trigger a sufficient immune response in some of the kids.
Instead of waiting for the expanded trial to be completed, the U.S. Food and Drug Administration (FDA) soon after asked Pfizer for data on the vaccine. Because of the spike in COVID-19 cases and hospitalizations from the Omicron virus variant, regulators were considering expanding emergency use authorization for the shot to the young population.
Officials appeared poised to grant the expanded authorization in February, but days before a scheduled vaccine advisory panel meeting, they announced they were postponing the decision.
“The data that we saw made us realize that we needed to see data from a third dose, as in the ongoing trial, in order to make a determination that we could proceed with doing an authorization,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told reporters on a call. He said he hoped the move would “reassure” people that the FDA was “making sure that anything that we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products.”
FDA officials declined to provide more insight into the reason for the postponement. Dr. Scott Gottlieb, a former FDA chief who sits on Pfizer’s board, said it stemmed from a “low number of cases overall in the clinical trial.”
“Most kids are not getting symptomatic COVID,” he said.
