Pfizer Halts Its Request For FDA Authorization of COVID Vaccines for Kids Under 5

Pfizer has decided to suspend its request to the U.S. Food and Drug Administration to get authorization for a two-dose COVID-19 for vaccines for children under five and will also hold off until the 3-dose data becomes available, which will likely be in early April.

“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.

“This is also supported by recent observations of three-dose booster data in several other age groups that seem to meaningfully augment neutralizing antibody levels and real-world vaccine protection for omicron compared to the two-dose regimen,” the company continued.

The U.S. government had been preparing to distribute the Pfizer/BioNTech vaccines for children, six months through 4 years old, for the 2-dose regimen upon receiving FDA approval.

While earlier data from the company showed the vaccine was considered safe and produced an immune response, the company announced last year that the two-dose shot proves to be less effective at preventing COVID-19 in kids ages 2-5. 

Late last year, the FDA and CDC authorized the vaccine for children ages 5-11 years old. The Pfizer-BioNTech two-dose series still remains the only vaccine that is recommended for children between the ages of 5-11 years old.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) was scheduled to discuss the authorization of the Pfizer vaccine for the age group Tuesday, but the meeting has been postponed.