The U.S. Food and Drug Administration announced Friday that it is postponing the meeting of its Vaccines and Related Biological Products Advisory Committee, originally scheduled for February 15, as "new data have recently emerged" regarding Pfizer and BioNTech’s emergency use authorization request for their COVID-19 vaccine for children younger than 5.
"This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines. We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity toxjmtzyw complete an updated evaluation," acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
In a news release Friday, Pfizer said it continues to share data from its child vaccine trial with the FDA. With the surge of the Omicron variant, high rates of infection and illness among children have allowed the company to quickly accumulate the data it needs for the study protocol.
"Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," the release says. "This is also supported by recent observations of three-dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen."
Pfizer and BioNTech expect to have three-dose protection data available in early April. The extension will give the FDA the time to examine data on the two- and three-dose regimens.
Pfizer said the study’s independent Data Monitoring Committee supports the continuation of the trial. It believes that the data collected indicates that the vaccine is well-tolerated and supports a potential three-dose regimen.
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A medical worker prepares a shot of Pfizer COVID-19 vaccine, at Belgrade Fair makeshift vaccination center, Serbia, Saturday, Oct. 2, 2021. (AP Photo/Darko Vojinovic)
