US to Possibly Authorize Pfizer Vaccine for Kids under Five by End of February

By Staff, Agencies

Pfizer and BioNTech are expected to submit an emergency use authorization request as early as Tuesday to the US 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 five could be available as soon with the end of 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 said 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."

Meanwhile, on Monday the FDA granted full approval to Moderna's Covid vaccine for adults 18 and up.

The vaccine has been available since December 2020 on an emergency basis, but the move is hoped to provide an extra boost of confidence in the vaccine.

The full approval was based on follow-up data showing "high efficacy and favorable safety approximately six months after the second dose."