Pfizer pauses request for FDA authorization of COVID vaccines for kids under 5, awaits more trial data
The company says the trial is ongoing and data is constantly being shared with the FDA
Pfizer is pushing pause on its requested authorization by the U.S. Food and Drug Administration for a two-dose COVID-19 vaccine for kids under five, and will hold off until the 3-dose data is available, likely in early April, the company said Friday.
"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," Pfizer said in a press release.
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"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," the company added.
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The U.S. government had been preparing to roll out the Pfizer/BioNTech vaccines for children 6 months through 4 years old as early as February for the 2-dose regimen upon FDA approval.
While early Pfizer data has shown the vaccine is safe and produces an immune response, the drugmaker announced last year that the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5.
In November, the FDA and CDC authorized the COVID-19 vaccine for children ages 5-11 years old. The Pfizer-BioNTech two-dose series currently remains the only recommended vaccine for children ages 5-11 years old.
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The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) had been scheduled to discuss authorization of the Pfizer vaccine for the age group on Feb. 15. That meeting has now been postponed.
FOX Business' Julia Musto contributed to this report.