FDA committee delays review of Pfizer-BioNTech’s COVID-19 vaccine for young children

US Food and Drug Administration (FDA) meeting to discuss licensing of Pfizer-BioNTech’s COVID-19 vaccine for children under the age of five, once again pushing back the vaccination timeline for the youngest Americans.

The FDA’s Advisory Committee on Vaccines and Related Biological Products was scheduled to meet on February 15 to discuss the emergency use authorization of Pfizer-BioNTech’s two-dose vaccine regimen approved by the FDA. Prepared for children from 6 months to 4 years old. (Pfizer is testing a dose of 3 micrograms for young children, smaller than the dose offered for adults and older children.) But on February 11, the FDA announced that Pfizer had notified the agency of new data from Clinical trials are ongoing. three-dose regimen for children, requiring a longer review period.
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“The FDA and Pfizer want complete studies of the three-dose product before reviewing the data,” said Dr. Paul Offit, director of the Children’s Hospital of Philadelphia’s Center for Vaccine Education and a member of the committee. FDA’s vaccine advisory board, wrote in an email to TIME.

The delay “will give the agency time to review additional data, allow for transparent public discussion as part of our normal scientific and regulatory process for COVID-19 vaccines.” The FDA said in a statement.

The FDA hasn’t announced a new date for the advisory committee meeting, but Pfizer and BioNTech said in a press release which they expect to have data on the three-dose vaccine schedule in early April. “As research is proceeding at a rapid pace, companies will await three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the statement said. said.

Read more: The childhood vaccine debate misses an important point: Children are not supposed to die

Pfizer’s rush to license vaccines for the youngest children was met with setbacks in December, when researchers announced that two doses of children’s vaccine did not produce a satisfactory immune response in children aged 2 to 4. At the same time, Pfizer announced that it has adjusted its study protocol to include a third dose, in the hope that it will cause a stronger reaction.

However, at the request of the FDA, Pfizer sent data on two-dose regimen in February so the agency could begin the emergency use authorization process as Omicron continues to threaten unvaccinated people.

More words TIME

“Ultimately, we believe that three doses of the vaccine for children aged 6 months to 4 years will be needed to achieve a high level of protection against current and potential future variants,” said the CEO. operations of Pfizer, Albert Bourla said in a statement at the time. “If two doses are allowed, parents will have the opportunity to start a series of COVID-19 vaccines for their child while awaiting the potential authorization of a third dose.” For now, however, that review has been paused pending further data.

It’s not clear what that additional data will mean for injection licensing among the millions of children under the age of 5 in the United States. But the parents — many of them already anxiously waiting for the vaccine for their little children—Possibility of demoralization during the extra wait.

“I’m frustrated as a mother, but I’d rather our regulators play it safe and wait for data from 3 doses rather than allowing 2 doses in the meantime,” said Dr. Leana Wen, professor at George University of Washington Milken Institute School of Public Health, wrote on Twitter.

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