FDA to meet in mid-February to discuss Pfizer-BioNTech COVID-19 vaccine for kids under 5

WASHINGTON - The US Food and Drug Administration (FDA) has scheduled a virtual meeting of its advisors on Feb. 15 to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for use in children 6 months through 4 years of age.

Pfizer and BioNTech have initiated a rolling submission seeking to amend the EUA of its COVID-19 vaccine to include children 6 months through 4 years of age, the two companies announced on Tuesday.

They expect to complete the EUA submission in the coming days. The application is for authorization of the first two 3 mcg doses of a planned three-dose primary series in this age group.

Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months, and will be submitted to the FDA to support a potential expansion of this requested EUA, according to the two companies.

The FDA authorized the Pfizer-BioNTech COVID-19 vaccine for use in children 5 through 11 years of age in October, 2021, and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older.