Pfizer Inc. and Germany’s BioNTech SE are expected to submit an emergency use authorisation request as early as Tuesday to the US Food and Drug Administration (FDA) for vaccines for children aged six months to 5 years, a local source reported on Monday. It is speculated that vaccines for children younger than 5 could be available sooner than expected – perhaps by the end of February.
“The idea is, let’s go ahead and start the review of two doses,” said an insider. “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, the source added.”
According to people familiar with the discussions, the Federal regulators urged the companies to submit the application so that regulators could begin reviewing the two-shot data.
The companies in the last few months have been testing the third dose, following disappointing results for the two-shot regimen showing that while the vaccine is safe, two doses did not provide a strong enough immune response in all age groups.
Parents of younger children have been eager to see Pfizer and federal regulators move to make the shots available. Many families have said they are in limbo waiting out the Omicron wave and grappling with daycare closures and child care crises.