Pfizer asked the Food and Drug Administration on Tuesday for emergency use authorization for its COVID-19 vaccine for children under the age of 5.
The move puts the process in motion for the FDA to review the data, bring it before its independent advisers and potentially authorize the vaccine in the coming weeks. The FDA independent advisers are already slated to have a public hearing on Feb. 15.
The data would then be brought before the Centers for Disease Control and Prevention's independent advisers for another review, and finally, a potential recommendation by CDC Director Rochelle Walensky -- all potentially within the month.
As of now, Pfizer's two-dose vaccine is available to anyone over 5 years old. A booster shot after five months is available to anyone over 12 years old. Moderna and Johnson & Johnson are available to adults.
Pfizer announced it had safety and efficacy for its vaccine for kids under 5 in December, but determined that the two-dose regimen wasn't as effective for children 2, 3 and 4 years-old as it was for adults. The dose for kids under 5 is one-tenth the dose for adults.
On Tuesday, Pfizer again submitted data on two doses of the vaccine, but with the expectation that data will soon be available to make it a three-dose vaccine, which will likely be more effective at preventing illness.
Pfizer is expected to have more information on the efficacy of a three-dose regimen in March or April, but authorizing the first two doses in February would start the immunization process earlier.
The third dose would be given at least eight weeks after the second dose.
“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,” Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said in a press release Tuesday.
“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.”
Some parents of young kids have been desperate for a shot to be authorized so they can protect their children against severe disease. Kids under the age of 5 have now spent nearly half of their lives in the pandemic, and for many parents their unvaccinated status has been a huge stressor.
Last week, about 808,000 children tested positive for COVID-19, down from the peak level of 1,150,000 reported the week ending Jan. 20, according to a new weekly report by the American Academy of Pediatrics (AAP) and the Children's Hospital Association (CHA).
However, the organizations warn that pediatric infections remain "extremely high," still triple the peak level of the summer delta surge in 2021.
A total of 11.4 million children have tested positive for the virus since the onset of the pandemic. Child COVID-19 cases have "spiked dramatically" during the omicron variant surge, with more than 3.5 million child cases reported in January.
Still, because kids are less likely to get seriously sick from COVID-19, many parents have opted not to vaccinate them even when they become eligible.
Nearly 70% of eligible kids ages 5 to 11 have yet to get a shot, according to a January survey from KFF, a nonpartisan health nonprofit. It's unclear how many parents will opt to vaccinate their children under 5, when the vaccine becomes available.
But experts point to many reasons to get children vaccinated, including their own health and the health of the community around them.
According to the CDC, unvaccinated 12 to 17-year-olds had an 11 times higher risk of hospitalization than fully vaccinated adolescents.
And while young kids are less likely to end up in the hospital, it's still possible. They can also be vectors for spread, infecting other, higher-risk adults in their community.
Both the delta and omicron surges saw full pediatric wards in hospitals, often with doctors pleading for communities to increase their vaccination rates.
This is a developing story. Please check back for updates.