Pfizer on Feb. 11 said it is postponing its rolling submission to the FDA as it waits for data on a three-dose COVID-19 vaccine regimen for children under 5. The extension means vaccines for young children will not be available later this month as federal health officials had anticipated.
Pfizer and BioNTech initially submitted an emergency-use authorization request for a two-dose vaccine regimen for children under 5 earlier this month, despite trial results from December indicating the regimen did not generate a strong immune response in 2- to 4-year-olds. The drugmakers at the time, anticipating authorization, said they moved ahead with the two-dose request to give parents "the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose."
The drugmakers will now "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," according to the Feb. 11 update. The drugmakers expect to have data on the three-dose regimen available by early April.
"The extension allows the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion," Pfizer said.