The Omicron wave of the coronavirus has now reached its peak in much of the United States. But the magnitude of the wave, which broke records for national cases and hospitalizations, has given regulators and scientists the opportunity to better assess vaccine efficacy in children 6 months to 4 years old, Dr. Scott Gottlieb, a former Commissioner of the Food and Drug Administration, said on Sunday.
dr. Gottlieb, who sits on the board of vaccine maker Pfizer, said he hopes key data expected Friday will shed more light on whether the federal government should grant emergency approval for two doses of Pfizer-BioNTech’s vaccine. for children of this age. group.
“We now have the opportunity to look at a much richer data set,” said Dr. Gottlieb on CBS’s “Face The Nation.” He did not specify what those data would reveal. Still, he stressed that the toll Omicron takes on children, in particular, gave Pfizer a stronger basis for comparison of those who did and did not receive vaccines.
“Some got infected, hopefully others didn’t,” he said of the test group. “I think that’s what the data package will show, and I think it will give a much clearer picture of” the efficacy of the vaccine against Omicron.
He said the newer data would help highlight results that were less rich before the full Omicron wave was reached.
At the urging of the federal government, Pfizer and its partner BioNTech last week applied for authorization for two doses of its vaccine for children ages 4 and under.
But the results released in December didn’t show the expected immune response in children ages 2 to 4. Children aged 6 months to 2 years showed a similar response as those of older teens and young adults.
The disappointing finding has led the companies to test a third injection in young children, but those results won’t be available for a few weeks. Still, hoping to jump-start vaccination efforts, the FDA urged the companies to apply for two-dose authorization while everyone waits for data on the third dose.
The thinking is that if two doses are approved and given, children will be prepared for a third dose if and when research shows that three injections prove to be fully effective.
That three doses will work is the working suspicion of Pfizer and some experts. Critics have argued that this strategy short-circuits the research process and that there is as yet no clear evidence that a third dose will make up for the shortcomings of two doses.
The coronavirus pandemic: important things to know
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The state of the virus in the US The coronavirus has now claimed more than 900,000 lives across the country and death rates from Covid remain alarmingly high. However, the number of new infections has fallen by more than half since mid-January and the number of hospital admissions is also decreasing.
boosters. New data from the Centers for Disease Control and Prevention confirmed that booster doses are most beneficial for older adults. For younger Americans, vaccination reduced the risk of hospitalization and death so much that the extra injection didn’t seem to add much benefit.
Around the world. Several countries are easing their pandemic protocols, though World Health Organization public health leaders continued to urge caution with easing restrictions. A sweeping Covid vaccine mandate will become law in Austria.
Full details of the trials have not been made public. But a person familiar with Pfizer’s 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 50 percent less infected than a placebo group, while children from 2 to 2 years to 4 years old became infected at a 57 percent lower rate.
dr. Surgeon General Vivek Murthy said last week there would be no cuts in Pfizer’s application for emergency vaccine approval in young children. The application, he said, would undergo “the same independent, rigorous and transparent review process” used to release the adult vaccine. He also mentioned the role of the Omicron peak and its impact on children.
“Whether that changes the risk-benefit profile is what the FDA will assess,” said Dr. murthy. “But there have been developments on the data front since December.”
This post Omicron helped clarify efficacy of Pfizer vaccine in young children, Gottlieb says
was original published at “https://www.nytimes.com/2022/02/06/health/pfizer-kids-vaccine-omicron.html”