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. 

Pfizer vaccines

Jackson-Hinds Comprehensive Health Center nurse Maggie Bass holds a vial of the Pfizer COVID-19 vaccine for children ages 5 - 11 on the right while in her left hand is a vial of the vaccine for adults, at the vaccination station next to Jackson State (AP Photo/Rogelio V. Solis / AP Newsroom)

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"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.

Pfizer vaccine

Vials labelled "COVID-19 Coronavirus Vaccine" and a syringe are seen in front of the Pfizer logo in this illustration taken February 9, 2021.  (REUTERS/Dado Ruvic / Reuters)

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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.

kids vaccine

A nurse administers a pediatric dose of the Covid-19 vaccine to a girl at a L.A. Care Health Plan vaccination clinic at Los Angeles Mission College in the Sylmar neighborhood in Los Angeles, California, January 19, 2022. (Photo by Robyn Beck / AFP) ( (Photo by Robyn Beck / AFP) (Photo by ROBYN BECK/AFP via Getty Images / Getty Images)

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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.