Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age

Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.

The vaccine, sold under the brand name Comirnaty, is FDA-approved for use in individuals ages 16 years and older. On May 10, 2021, it received an EUA for children 12 through 15 years of age, and on October 29, the EUA was extended to include children as young as 5 years old. I

If the new authorization is granted, this will be the first COVID-19 vaccine authorized for use in children younger than 5 years of age.

In light of the increase in reported COVID-19 cases and hospitalization in children younger than four years during the surge of theomicron variant of the SARS-CoV-2 virus that causes COVID-19, the FDA has requested that the companies apply for EUA in this age group. The petition is for the authorization of two 3-mcg doses given three weeks apart, although earlier trials did not yield satisfactory results after two vaccine doses in children ages 2 to 4 years.

Pfizer and BioNTech intend to submit additional data on a third dose given eight weeks after the second in the coming months. Officials believe that, meanwhile, children can begin the vaccination series and be ready for a third dose by the time that data is released.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Albert Bourla, Chairman and Chief Executive Officer at Pfizer, said in a press release.

An FDA advisory committee will meet on Feb. 15 to discuss Pfizer-Biotech's request for EUA.