Pfizer May Apply for FDA Approval of COVID-19 Vaccine for Younger Children in November

Speaking at an industry conference, Pfizer CFO Frank D’Amelio told the audience he hoped the company would “go file” for full Food and Drug Administration (FDA) approval for the Pfizer-BioNTech BNT162b2 (Comirnaty) COVID-19 vaccine for children 6 months to 5 years old in November.

“We would expect to have . . . data for children between the ages of six months and five years old that we would file with the FDA,” D’Amelio said. “I’ll call it in the weeks shortly thereafter the filing of the data for the five- to 11-year-olds.”

This was reported in the Financial Times.

This potential filing for approval falls in line with the other recent filings and approvals. The companies announced in late August that they were initiating a rolling submission for their COVID-19 vaccine to seek an FDA supplemental Biologics License Application (sBLA) that would allow for marketing and prescribing of a third booster dose of the vaccine for fully vaccinated individuals aged 16 years and older.

The booster dose pursuit came 2 days after the collaborating pharmaceutical companies received a BLA for BNT162b2—the very first COVID-19 vaccine given full approval by the FDA.

In addition, BioNTech CEO Ugur Sahin and CMO Ozlem Türeci, MD told a German news site recently they expect to seek approval for the Pfizer-BioNTech vaccine for the 5 to 11 year old population soon, and potentially could see the first doses of the vaccine for that age group become available in Europe by mid-October.

"In the coming weeks we will present the results of our study on the 5 to 11 year olds worldwide to the authorities and apply for approval of the vaccine for this age group, including here in Europe," Türeci told SPIEGEL.