Pfizer and BioNTech are expected to submit an emergency use authorisation request on Tuesday to the US Food and Drug Administration (FDA) for vaccines for children aged 5 years and below.
Coronavirus vaccines for children aged six months to five years could be available as soon as end-February under a plan that would lead to the potential authorisation of a two-shot regimen in the coming weeks, the Washington Post reported, citing people briefed on the situation.
The report says that the FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data.
"The idea is, let's go ahead and start the review of two doses," the report quoted one of the people familiar with the situation as saying. "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."
Pfizer, BioNTech and the FDA did not immediately respond to Reuters requests for comment.
Pfizer said in January it expected the latest results from a clinical trial for kids under the age of five by April, after it amended its study to give a third dose to everybody who's less than five at least eight weeks after their last vaccination.
The company amended the study because children between the ages of two and four who were given two 3-microgram doses of the vaccine did not have the same immune response that a larger dose of the vaccine generated in older children.
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