By now, the Omicron wave of the coronavirus has peaked across much of the United States. But the size of the surge, which broke national records for cases and hospitalizations, gave regulators and scientists an opportunity to better assess the vaccine’s effectiveness in children aged 6 months to 4 years, said said Dr. Scott Gottlieb, former commissioner of the Food and Drug Administration, said Sunday.
Dr Gottlieb, who sits on the board of vaccine maker Pfizer, said he hoped key data due Friday would shed more light on whether the federal government should grant emergency authorization for two doses of the Pfizer-BioNTech vaccine for children of this age. group.
“We now have the opportunity to look at a much richer data set,” Dr. Gottlieb said on CBS’ “Face The Nation.” He did not specify what that data would reveal. Still, he pointed out that Omicron’s track record on children in particular gives Pfizer a stronger basis for comparing those who have received vaccines and those who have not.
“Some got infected, hopefully some didn’t,” he said of the testing 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 effectiveness of the Omicron vaccine.
He said the most recent data would help illuminate results that were less rich before Omicron’s full wave peaked.
At the request of the federal government, Pfizer and its partner BioNTech last week applied for authorization for two doses of its vaccine for children 4 and under.
But the results published in December did not show the hoped-for immune response in children aged 2 to 4. Children 6 months to 2 years showed a response comparable to older adolescents and young adults.
The disappointing finding has led the companies to test a third vaccine in young children, but those results won’t be available for a few weeks. Still, in hopes of jump-starting the vaccine effort, the FDA has urged companies to seek approval for two doses while everyone waits for data on the third dose.
The idea is that if two doses are authorized and given, children would be prepared for a third dose if and when research shows three injections to be fully effective.
That three doses work is the working presumption of Pfizer and some experts. Critics have argued that this strategy short-circuits the research process and that there is not yet clear evidence that a third dose will make up for the shortcomings of two doses.
The coronavirus pandemic: essential things to know
The state of the virus in the United States The coronavirus has now claimed more than 900,000 lives across the country, and Covid death rates remain alarmingly high. However, the number of new infections has more than halved since mid-January, and hospitalizations are also down.
Full trial data has not been made public. But a person familiar with the Pfizer research, who spoke on condition of anonymity, recently told the New York Times that children 6 months to 2 years old who received two doses were infected at a 50% lower rate. than a placebo group, while children 2 to 4 years old were infected at a 57% lower rate.
Dr Vivek Murthy, the surgeon general, said last week that no shortcuts would be cut with Pfizer’s request for emergency authorization of the vaccine in young children. The application, he said, “would be subject to the same independent, rigorous and transparent review process” that was used to authorize the vaccine for adults. He also cited the role of Omicron’s push and its impact on children.
“Will the FDA assess whether this changes the risk-benefit profile,” Dr. Murthy said. “But there have been developments since December on the data front.”