FDA Committee Postpones Review of Pfizer-BioNTech’s COVID-19 Vaccine for Young Children

The U.S. Food and Drug Administration (FDA) has postponed a meeting to discuss approval of Pfizer-BioNTech’s COVID-19 vaccine for children under five, once again shifting the timeline for vaccinating the youngest Americans.

The FDA’s Advisory Committee on Vaccines and Related Biologics is set to meet on Feb. 15 to discuss emergency authorization of a two-dose regimen of Pfizer-BioNTech’s vaccine formulated for children ages 6 months to 4 years. (Pfizer is testing a three-microgram dose for young children, smaller than doses offered to adults and older children.) But on Feb. 11, the FDA announced that Pfizer had notified the agency of new data from its ongoing clinical trial. trial involving a three-dose regimen for children, requiring a longer assessment period.
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“FDA and Pfizer want completed studies on the three-dose product before reviewing the data,” wrote Dr. Paul Offit, director of the Children’s Hospital of Philadelphia’s Vaccine Education Center and a member of the FDA’s Vaccine Advisory Committee, in an email to TIME.

The delay “gives the agency time to consider the additional data, allowing for transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines,” the FDA said in a statement.

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

Read more: The childhood vaccination debate ignores a pivotal point: Children are not supposed to die

Pfizer’s rush to get its vaccine for the youngest children was met with a backlash in December when researchers announced that two doses of the pediatric vaccine failed to elicit a satisfactory immune response in children ages 2 to 4. At the same time, Pfizer announced it had modified its research protocol to include a third dose, hoping it would elicit a stronger response.

Nevertheless, at the request of the FDA, Pfizer submitted data on the two-dose regimen in February so that the agency could begin the emergency authorization process in light of Omicron’s continued threat to unvaccinated people.

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“Ultimately, we believe that three doses of the vaccine will be necessary for children aged 6 months to 4 years to achieve a high level of protection against current and potential future variants,” Pfizer CEO Albert Bourla said at the time. a statement. “If two doses are approved, parents will have the option to initiate a COVID-19 vaccination series for their children pending possible approval of a third dose.” Now, however, that review process has been paused to wait for more data.

It’s not clear what those additional data will mean for the authorization of the injection among the millions of children under the age of 5 in the US. †

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



This post FDA Committee Postpones Review of Pfizer-BioNTech’s COVID-19 Vaccine for Young Children

was original published at “https://time.com/6147511/fda-delays-covid-19-vaccine-kids/”