Pfizer Will Ask FDA to Approve Its COVID-19 Vaccine for Children Under 5 Years
If approved, the two-shot regimen would become the first approved for use in children this young
By Physician’s Briefing Staff | February 01, 2022
Pfizer Inc. plans to ask the U.S. Food and Drug Administration as soon as Tuesday to authorize its COVID-19 vaccine for emergency use in children aged 6 months to 4 years old.
If approved, the two-shot regimen would become the first approved for use in children this young; older children are already eligible for the vaccine. In December, Pfizer suffered a setback when it announced that two doses of the vaccine, which are one-tenth the amount of an adult dose, did not produce a sufficient immune response in children aged 2 to 4 years. The company has already started testing a third dose in this age group.
"At this time, we have not filed a submission and we're continuing to collect and analyze data from both two and three doses in our younger age cohort," Pfizer spokeswoman Jerica Pitts told The Washington Post on Monday. "As part of our ongoing commitment, we will share new updates as they become available."
But federal regulators have been eager to review the Pfizer data in hopes of authorizing shots for young children as early as the end of February, multiple people familiar with the discussions told The Post . If Pfizer waits for data on three doses in these youngest Americans, the data would not be submitted until late March and the vaccine might not be authorized for that age group until weeks later, the newspaper said.
"We know that two doses isn't enough, and we get that," one of the people familiar with the situation told The Post . "The idea is, let's go ahead and start the review of two doses. 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."
Last Friday, Pfizer briefed federal health officials on updated trial data on the shots, an administration official who spoke on the condition of anonymity, told the newspaper. The session included a "robust conversation" that three doses were likely to be much more powerful than just two shots, the administration official said. "But to get to three, you have to get two shots first," the official told The Post . Expert advisory panels to both the FDA and the U.S. Centers for Disease Control and Prevention are expected to meet on the two-dose application sometime in February.