Pfizer Asks FDA to Approve Its Vaccine for Children Under 5

Pfizer Inc. announced Tuesday that it has asked the U.S. Food and Drug Administration to authorize its two-dose COVID vaccine for emergency use in children under 5 while it continues to research the power of a third shot in these youngest Americans.

If the FDA grants the request, 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. The company has already started testing a third dose for this age group.

“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer Chairman and CEO Albert Bourla, said in a company statement announcing the move.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants,” Bourla added. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”

It is a strategy federal regulators have encouraged as they have been eager to review Pfizer’s data in hopes of authorizing shots for young children as early as the end of February, multiple people familiar with the discussions told the Washington Post. If Pfizer waits for data on three doses, the request would not be submitted until late March.

“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 Post.

Those attending the briefing included Dr. Anthony Fauci; David Kessler, chief science officer for the government’s COVID-19 response; a representative from the U.S. Centers for Disease Control and Prevention; and other officials from the U.S. Department of Health and Human Services, the Post reported.

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. … There’s interest in seeing this move forward,” the official told the Post.

In that vein, an FDA advisory panel will weigh the two-dose regime on Feb. 15.