Pfizer asks FDA to approve its COVID-19 vaccine for children under 5

Pfizer and BioNTech SE have urged the U.S. Food and Drug Administration (FDA) to approve their COVID-19 vaccine for children between the ages of six months and five years.

The companies said in a statement that if authorisation is granted, the vaccine would be the first COVID-19 vaccine available for pediatric populations under the age of five.

The companies expect to complete the emergency use authorisation submission in the coming days.

The application is for authorisation of the first two three-microgram doses of a planned three-dose primary series in the age group.

Data on a third dose given at least eight weeks after completion of the second dose are expected in the coming months.

It will be submitted to the FDA to support a potential expansion of the requested EUA.

The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb.15, to discuss the request for emergency use authorisation of the Pfizer-BioNTech COVID-19 vaccine for the age group.

Janet Woodcock, acting FDA Commissioner said having a safe and effective vaccine available for children in this age group is a priority for the agency.

“We’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge.

“The FDA authorised the Pfizer-BioNTech COVID-19 vaccine for use in children five through 11 years of age in October 2021.

“It recently authorised the use of a single booster dose in individuals 12 through 15 years of age and older.”

The vaccine had been authorised for emergency use in the U.S. since December 2020 for people age 16 and older.