A former commissioner for the Food and Drug Administration said Sunday that the size of the omicron wave, which led to record numbers of covid-19 cases and hospitalizations, has given regulators and scientists an opportunity to better assess vaccine efficacy in young children.
Dr. Scott Gottlieb, who sits on the board of the vaccine-maker Pfizer, said he hopes that 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 ages 6 months to 4 years old.
"We now have an opportunity to look at a much richer data set," Gottlieb said on CBS' "Face the Nation." He did not specify what that data would reveal, but he emphasized that the toll the omicron variant took on children in particular gave Pfizer a stronger basis for comparison of those who were vaccinated and those who were 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.
The surge caused by the omicron variant has crested in much of the United States. But at the urging of the federal government, Pfizer and partner BioNTech applied last week for authorization for two doses of its vaccine for children 4 and younger.
But results released in December did not show the hoped-for immune response in children ages 2-4. Children from 6 months to 2 years old showed a comparable response to that of older teenagers and young adults.
The findings led the companies to test a third shot in young children, but those results will not be available for a few weeks. Still, the FDA urged the companies to apply for authorization of two doses while everyone awaits data on the third dose, in hopes of getting a jump-start on the vaccination effort.
The thinking is that if two doses are authorized and given, then children will be prepared for a third dose if research demonstrates that three shots prove fully effective.
The idea that three doses will work is the 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 from the trials has 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 U.S. surgeon general, said last week that no corners will be cut with Pfizer's application for emergency authorization of the vaccine in young children. The application, he said, will "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."
Gallery: Coronavirus scenes, 2-6-2022
