On Sunday, former FDA Commissioner Dr. Scott Gottlieb said that a COVID-19 vaccine for children age 4 and under could be approved as early as March.
“Gottlieb said the authorization would depend on whether federal officials move forward with Pfizer’s two-dose candidate, as opposed to the three-dose one added last month to the company’s clinical trials,” The New York Post reported. “The two-dose shot could presumably be approved the fastest of the two, since trials on it are further ahead, so it’s just a question of whether its potency is considered enough protection for the age group at this point, Gottlieb said.”
Gottlieb told CBS anchor Margaret Brennan, “Getting two doses into a child can provide baseline immunity that protects them from severe disease [and] from hospitalization.”
“And I think that may be why federal health officials are rethinking this if, in fact, they decide to authorize this on the basis of two doses. It could be out much sooner, perhaps as early as early March,” he added.
Pfizer recently announced that it was reviewing the effects of a third dose of the vaccine after discovering that two shots did not cause the same level of immune response in 2- to 5-year-olds as with adults.
But Gottlieb explained that the two dose regimen prevents severe disease, 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 continued.