Parents may soon be able to get children as young as 6 months old vaccinated against COVID-19.
Pfizer has begun the submission process to get its COVID-19 vaccine authorized by the U.S. Food and Drug Administration. If granted, it would become the first COVID-19 vaccine available for children under age 5.
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Pfizer and BioNTech, which helped develop the vaccine, said they expect to finish the submission process in the coming days.
The FDA's vaccine advisory committee will meet Feb. 15 to discuss the safety and effectiveness of the vaccine for the youngest children. The vaccine already has been authorized for children 5 years and older.
Dr. Paul Offit, a committee member and director of the Vaccine Education Center at Children's Hospital of Philadelphia, told CNN that the confidence of the American public depends on the data.
"The data will tell us just how good these are," Offit said. "There should be a robust safety profile and a robust efficacy profile and immunogenicity profile. And if that's true, speed doesn't really matter, as long as they have those data."
In December, the companies said the results of the two-dose series were disappointing among children ages 2-4. But the companies have decided to pursue authorization while exploring whether a three-dose series offers better protection. The third dose is given at least eight weeks after the second dose.
The companies cited the "urgent public health need" as the reason to seek authorization. According to the American Academy of Pediatrics, there were more than 3.5 million cases among children in January.
"As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus," Pfizer Chairman and CEO Albert Bourla said.
"Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose."
The companies have not yet publicly released safety and efficacy data.
The vaccines could be available in just several weeks if the authorization process proceeds as rapidly as it did for children ages 5-11 last fall. In that case, vaccines were authorized about four weeks after Pfizer submitted its data.
The FDA will use the recommendation from its advisory committee to inform its decision on whether to grant an emergency use authorization.
If the vaccine is authorized, a U.S. Centers for Disease Control and Prevention committee will then make a recommendation on whether the vaccine should be given to all children in this age group or only certain subgroups. Finally, CDC Director Rochelle Walensky will make an official recommendation, prompting the rollout of the vaccine.
The dose for children under 5 is 3 micrograms, much lower than the 10 micrograms authorized for older children. The Pfizer vaccine dose for adults is 30 micrograms.
Moderna also is testing its vaccine in this age group and expects to submit data to the FDA on children ages 2-5 in March. Johnson & Johnson has said it will be starting clinical trials on this age group too.