According to a Monday report by the Washington Post, Pfizer Inc and Germany’s BioNTech SE are expected to submit an emergency use authorization request today to the FDA for vaccines for children aged six months to 5 years.
If the report stands true, and the authorization request is filed today, the vaccine may be available for children below five as early as the end of February. The report says that the FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data with the motive of safeguarding young children against current and future waves of the coronavirus.
“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 hold 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.”
Following the report, neither of the pharma houses commented on the matter as of Monday.