By now, the omicron wave of the coronavirus has crested in much of the United States. But the size of the wave, which broke records for national cases and hospitalizations, has given regulators and scientists an opportunity to better assess vaccine efficacy in children ages 6 months to 4 years old, Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration, said Sunday.
Gottlieb, who sits on the board of the vaccine-maker Pfizer, said he hopes key data expected on Friday will shed additional light on whether the federal government should grant emergency authorization for two doses of Pfizer-BioNTech’s vaccine for children in this age group.
“We now have an opportunity to look at a much richer data set,” Gottlieb said on CBS’s “Face The Nation.” He did not specify what that data would reveal. Still, he emphasized that the toll omicron took on children in particular gave Pfizer a stronger basis for comparison of those given vaccines and those not.
“Some got infected, hopefully some didn’t,” he said of the test group. “I think that’s what the data package is going to show, and I think it’s going to give a much clearer picture of” the vaccine’s efficacy against omicron.
He said the newer data would help illuminate results that had been less rich before the full omicron wave had crested.
At the urging of the federal government, Pfizer and its partner BioNTech applied last week for authorization for two doses of its vaccine to children 4 and younger.
But results released in December did not show the hoped-for immune response in children ages 2-4. Children 6 months to 2 years old showed a comparable response to that of older teenagers and young adults.
The disappointing finding has led the companies to test a third shot in young children, but those results will not available for a few weeks. Still, in hopes of getting a jump start on the vaccination effort, the FDA urged the companies to apply for authorization of two doses while everyone awaits data on the third dose.
The thinking is that if two doses are authorized and given, then children would be prepared for a third dose if and when research demonstrates that three shots prove fully effective.
That three doses will work is the working presumption of Pfizer and some experts. Critics have argued that this strategy is short-circuiting the research process and that there is not yet clear evidence that a third dose will make up for the inadequacies of two doses.
The full data on the trials have not been made public. But one person familiar with Pfizer’s research, who spoke on condition of anonymity, told The New York Times recently that children 6 months to 2 years old who received two doses became infected at a 50% lower rate than a placebo group, while children 2-4 years old became infected at a 57% lower rate.
Dr. Vivek Murthy, the surgeon general, said last week that no corners would be cut with Pfizer’s application for emergency authorization of the vaccine in young children. The application, he said, would “undergo the same independent, rigorous and transparent review process” that was used to clear the vaccine for adults. He also cited the role of the omicron surge and its impact on children.
“Whether that changes the risk-benefit profile is what the FDA will be assessing,” Murthy said. “But there has been developments since December on the data front.”
This article originally appeared in The New York Times.
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