Pfizer could file for authorization for its COVID-19 vaccine for children younger than 5 as early as Tuesday, according to a report from The Washington Post that was later confirmed by CNN and The New York Times.
According to the reports, officials believe the vaccine for young children could be authorized on an emergency basis by the end of the month.
The outlets say that the FDA will weigh a two-shot regimen of the Pfizer vaccine for young children, though it will continue to research if a three-dose regimen produces a better immune response.
The officials cited in the reports say that if Pfizer waited for full data on a three-dose regimen for a young children's vaccine, it would not be able to file for authorization until late March, and emergency approval may not have come until later in the spring.
In mid-December, Pfizer reported that its vaccine did not produce an adequate response in children aged between 2 and 4. As a result, the company said children in that age group who were participating in the trial would need a third dose of the vaccine two months after their second shot.
"Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis," Pfizer's press release at the time said.
Pfizer's potential filing comes as the highly-contagious omicron variant continues to spread across the U.S., resulting in a sharp rise in infections among children.
Pfizer's vaccine is fully approved for people as young as 16 and is available through emergency use authorization for kids as young as 5.
The FDA issued full approval to Moderna's COVID-19 vaccine for people aged 18 and up on Monday.