Pfizer-BioNTech has postponed its request that the Food and Drug Administration approve its COVID-19 vaccine for children under 5, saying it wants to wait for data on a third dose in that age group before proceeding.
Data has shown that the company’s two-dose regimen triggers a strong immune response in children under 2, but that the effects aren’t as strong in kids between the ages of 2 and 5. Pfizer-BioNTech initially said it would seek approval for the two-dose regimen while it continued to research whether a third shot could help kids older than 2.
But the company said Friday that it’s more practical to request approval for all three doses at once.
“Given that the study is advancing at a rapid pace, the companies 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,” the company said, adding that it expects the data on a third dose in early April.
The vaccine maker believes a three-dose regimen will prove be the most effective for children in the proposed age group, which would start at 6 months of age.
“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,” Pfizer-BioNTech said in its statement.
FDA leaders said they supported the decision, writing in a statement on Friday that they “believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”
The FDA committee that would have taken on the approval process was originally scheduled to meet next week.