The Food and Drug Administration announced today that Pfizer Inc. and BioNTech have announced plans to amend their Emergency Use Authorization seeking approval from the FDA for the COVID-19 vaccine for children 6 months through 4 years. A request that came from the FDA.
The company plans to continue submitting data and extend its rolling submission to the FDA. The trial for children 6 months through 4 years is "ongoing" the company said in a statement, and "data on the first two doses in this age group are being shared with the FDA" Pfizer said.
The FDA said Friday that Pfizer notified the agency regarding "additional findings" which has emerged about their EUA request for the Pfizer-BioNTech COVID-19 vaccine and its use in children 6 months to 4 years.
The FDA said in a tweet, "Based on our preliminary assessment, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization."
The delay will give the FDA additional time to consider data, "allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines," the agency said.
The FDA had a Vaccines and Related Biological Products Advisory Committee meeting scheduled to take place on Feb. 15, but the agency is postponing that meeting while additional data is collected.
The FDA said in a statement Friday, "Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study."
In a press call Peter Marks, Director for the FDA's Center for Biologics said that the data for the submission was coming into the agency so fast, the agency ultimately decided to delay the approval so that the data could be properly looked over and understood.
Marks said that the FDA needs to see data from a third dose in the trial for children under 5-years-old before moving forward in the authorization of the vaccine for this age group.
"What we're dealing with is taking the approach that we should take, as a public health agency, is taking the data coming into us and constantly adjusting to the data," Marks said.
Marks said the FDA is committed to moving as fast as the agency can on the EUA approval process once additional data is submitted.