Washington: The US Food and Drug Administration (FDA) has scheduled a virtual meeting of its advisors on February 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, Xinhua news agency cited the two pharma majors as saying in a joint announcement.
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 eight 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.