February 15, 2022 -- Pfizer and BioNTech extended their rolling submission to the U.S. Food and Drug Administration (FDA) to amend the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to include children six months old through four years of age.
In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third 3 μg dose at least two months after the second dose of the two-dose series in this age group. The companies expect to have three-dose protection data available in early April.
The independent data monitoring committee for the study supports continuing the trial according to the protocol and believes that the data collected to date indicate the vaccine is well tolerated and supports a potential three-dose regimen. 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.
The phase I/II/III trial initially enrolled 4,500 children ages 6 months old to under 12 years of age in the U.S., Finland, Poland, and Spain from more than 90 clinical trial sites. Emergency uses of the vaccine have not been approved or licensed by FDA but have been authorized by FDA under a EUA to prevent COVID-19 in individuals five years of age and older.