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.
