FDA delays meeting on kid vaccines as Pfizer promises more data

But FDA asked them last month to begin submitting data to support emergency use authorization for the first two shots in the expected three-dose series as the Omicron variant sickened more children than at any other point in the pandemic.

The regulators suggested the interim data was insufficient to begin considering authorization of the vaccine before the trial of three doses is complete. Pfizer and BioNTech said in a statement they expect data on the three-dose regimen by early April. In a call with reporters, Marks did not say when the vaccine for children under 5 would be considered, but that FDA would act quickly once it has sufficient data. He repeatedly declined to describe specific data that spurred the agency’s decision to postpone the meeting.

He added that it’s “probably a safe assumption” that, by waiting for more data, FDA will be able to consider an emergency use authorization for the youngest children based on data from actual infections, rather than just measuring antibody levels and comparing them to older kids.

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