WASHINGTON (REUTERS) – Pfizer Inc and Germany’s BioNTech SE are expected to submit an emergency use authorisation request on Tuesday (Feb 1) to the US Food and Drug Administration (FDA) for vaccines for children aged six months to five years, the Washington Post reported on Monday.
Coronavirus vaccines for children younger than five 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 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.
Pfizer, BioNTech and the FDA did not immediately respond to Reuters requests for comment.
Pfizer had earlier said it expected the latest results from a clinical trial for children under the age of five by April.