The US Food and Drug Administration (FDA) has scheduled a virtual meeting of its advisors on 15 February 2022 to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children aged 6 months through 4 years.
Pfizer and BioNTech have initiated a rolling submission seeking to amend the Emergency Use Authorization of its COVID-19 vaccine to include children in the age groups of 6 months to four years.
They expect to complete the EUA submission in the coming days. The application seeks authorization for the first two doses of a planned three-dose primary series of vaccinations for 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.
(This story was published from a syndicated feed. Only the headline and picture has been edited by FIT.)
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