Pfizer Inc. and BioNTech SE said late Tuesday they have asked the U.S. Food and Drug Administration to authorize the emergency use of their COVID-19 vaccine for children under 5, saying that three doses of the vaccine may be needed.
Pfizer PFE, +0.72% and BioNTech BNTX, +4.37% said they are asking federal authorities to amend their vaccine’s emergency use authorization to include children from 6 months of age through 4 years old. The submission is expected to be completed “in the coming days,” Pfizer said.
The application is for authorization of the first two doses of a planned three-dose series in this age group, the companies said.
The FDA said it plans a virtual meeting of its advisory committee Feb. 15 to discuss the request. If approved, the first shots could be administered as soon as later this month.
Data on a third dose given at least 8 weeks after 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, Pfizer and BioNTech said.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer Chief Executive Albert Bourla said in a statement. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”
If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose, he said.
Shares of Pfizer edged higher in the after hours Tuesday, and American depositary receipts of BioNTech rose 1% after the news, which had been expected.
The Pfizer-BioNTech COVID-19 vaccine was first authorized in the U.S. in an emergency basis in December 2020 for people 16 and older.