Pfizer and its partner BioNTech have resubmitted their application to have a three-dose COVID-19 vaccine for children aged 6 months to 4 years old gain emergency use authorization from the FDA. The FDA reportedly accepted Pfizer’s application to look at the data Wednesday.
“Pfizer and BioNTech completed a rolling application to the US Food and Drug Administration for emergency use authorization,” Pfizer said in an emailed statement.
Pfizer had previously asked the FDA to authorize its vaccine for kids 6 months to 4 years in February but postponed its request pending more data. Pfizer said last week that trials showed its three-dose vaccine produced a strong immune response in children under 5.
Ahead of the expected submission, the FDA last week said its Vaccines and Related Biological Products Advisory Committee would meet on June 15 to discuss emergency use authorization requests for Pfizer and Moderna vaccines for children aged 6 months and over.
Moderna asked for approval at the end of April. Moderna’s vaccine for children under 5 involves two doses of its 25 microgram vaccine (one-fourth of the volume of the adult Moderna dose). Pfizer’s is three 3-microgram doses — one-tenth of the dose for adults.
“We recognize parents are anxious to have their young children vaccinated against COVID-19, and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach,” the FDA told ABC News in a statement.
The FDA didn’t immediately respond to a request for comment. The vaccine would have to be approved by the committee before the full FDA, followed by CDC approval.
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