On Friday, Pfizer and BioNTech announced that they are postponing their application to the FDA for their COVID-19 vaccine to be approved for children ages six months to four years old.
According to Axios, the companies said they “will wait for the three-dose data” because they “believe it may provide a higher level of protection in this age group.”
“The trial in children 6 months through 4 years of age is ongoing and data on the first two … doses in this age group are being shared with the FDA on an ongoing basis,” Pfizer said in a statement.
“Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge,” the company added. “The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.”
Data on the third dose is expected to be released by April. As noted by The New York Times, Pfizer’s head of vaccine research has said that the company plans to get approval for a three-dose vaccine regimen for children under five.
“Kathrin Jansen, Pfizer’s head of vaccine research, said in December that the company would seek F.D.A. clearance for three doses for young children, a strategy that she said would allow for ‘a consistent three-dose vaccine approach for all ages,’” The New York Times reported. “The company switched its plan because the F.D.A. was pressing for more urgent action, two people said. If authorized, young children will receive their second dose three weeks after the first, and a third dose two months after that.”
However, former FDA Commissioner Dr. Scott Gottlieb said that just two doses of the vaccine is enough two prevent severe disease in children, which could be enough even though it does not prevent infection.
“I think the decision matrix has changed around the vaccine for [ages] 6 months to 4 years old and so far as we know that the vaccine isn’t as protective at preventing infection,” Gottlieb said. “Previously, we had data showing that the childhood vaccine for 6 months to 4 years wasn’t as protective against infection as the adult vaccine.”
“That’s the reason why they pushed it out and asked for that third dose. But now, if the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes, and you’re really not using the vaccine as a tool to prevent infection in the first place, two doses could do that,” he added.
