Pfizer Inc and Germany's BioNTech SE are expected to submit an emergency use authorization request as early as Tuesday to the U.S. Food and Drug Administration (FDA) for vaccines for children aged six months to 5 years, the Washington Post reported on Monday.
Coronavirus vaccines for children younger than 5 could be available as soon as end-February under a plan that would lead to the potential authorization of a two-shot regimen in the coming weeks, the 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.
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