BRIEF—Pfizer-BioNTech COVID-19 rolling submission for in infants extended

Pfizer and BioNTech SE plan to extend their  rolling submission to the US Food and Drug Administration (seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty, to include children six months through four years of age, which had been requested by FDA.

The trial in children six months through four years of age is ongoing and data on the first two 3µg doses in this age group are being shared with the FDA on an ongoing basis. In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third 3µg dose at least two months after the second dose of the two-dose series in this age group. Given that the study is advancing at a rapid pace, the companies believe it is important to wait for the three-dose data as the companies continue to believe it may provide a higher level of protection in this age group.

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.