Pfizer-BioNTech is expected as soon as Tuesday to ask the Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for its COVID-19 vaccine for children ages six months to five years old, and approval could be given by the end of February, The Washington Post reports.
The Pfizer vaccine is available for older children, but the researchers have reported facing problems with younger children not having as strong of an immune response with only two doses.
Companies are reportedly beginning testing for children to receive a third dose of a COVID vaccine, but data will not be available until late March.
“The idea is, let’s go ahead and start the review of two doses,” a source told the Washington Post. “If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”
Chief White House Medical Advisor Dr. Anthony Fauci predicted last week that children would likely need a “three-dose regimen.”
One official told the Post that Pfizer had a “robust conversation” last week about children receiving three doses of the COVID vaccine during a presentation to Biden Administration health experts.
“But to get to three, you have to get two shots first,” the official said. “There’s interest in seeing this move forward.”
Children in the Pfizer trial received two shots that were one-tenth of the vaccine dose given to adults. Pfizer announced in December that a third dose needed to be evaluated determine vaccine efficacy for children.
