Kids under 5 may get COVID vaccine by early March: Gottlieb

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Former FDA Commissioner Dr. Scott Gottlieb said Sunday that a COVID-19 vaccine for children age 4 and under could be approved by early 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 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.

“Getting two doses into a child can provide baseline immunity that protects them from severe disease [and] from hospitalization,” the-ex-Food and Drug Administration chief told anchor Margaret Brennan on CBS’s “Face the Nation.”

“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.”

Vaccine vial.
Pfizer found that two shots didn’t elicit the same kind of robust immune response in 2- to 5-year-olds as with adults.
Ute Grabowsky/Photothek via Getty Images

Pfizer had announced that it was amending its clinical trials and reviewing the effects of a third dose after finding two shots didn’t elicit the same kind of robust immune response in 2- to 5-year-olds as with adults.

But Gottlieb said it may be enough that the two-dose regimen prevents severe disease, as opposed to stopping infection entirely.

“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,” he said.

Child gets vaccinated.
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.
Ute Grabowsky/Photothek via Getty Images

“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,” he said.

“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.

Last week, Dr. Anthony Fauci offered a different prediction.

Child gets vaccinated.
The two-dose Pfizer vaccine has been authorized for kids 5 and older since late October.
Joseph Prezioso/AFP via Getty Images

“It looks like it will be a three-dose regimen,” he said at a White House COVID-19 briefing on Wednesday, though he added that he can’t speak for the FDA, which must give the first round of potential approval before use, followed by the CDC for the final OK.

The two-dose Pfizer vaccine has been authorized for kids 5 and older since late October, while anyone 12 and up are eligible for an additional booster.

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