A coronavirus vaccine for children between the ages of 6-months and 5-years-old could be just weeks away from approval.
Pfizer and BioNTech are apparently ready to ask the Food and Drug Administration to authorize their two-dose COVID-19 vaccine for use in young children.
The drugmakers are expected to submit a request for emergency-use authorization much earlier than anticipated -- as soon as Tuesday, according to the Washington Post.
If approved, it would be the first COVID-19 vaccine available for the age group.
Approval by federal regulators could come by the end of February. It would allow young children to begin receiving the low-dose, two-shot regimen while Pfizer and BioNTech continue to test the effectiveness of a third shot for the age group.
"The idea is, let's go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don't do anything until the third-dose data comes in," a person familiar with the situation told the Washington Post.
The companies have been testing a three-dose regimen in younger children following disappointing results from two-dose trials in December. The data showed that while the two-shot regimen triggered a protective immune response in children ages 6 months to 2 years, the vaccine was not triggering a strong enough response in kids 2- to 4-years-old. That's when a third shot was added to the trial.
Test results for the third shot reportedly won't be available until late March. If federal regulators authorize the vaccine based on two doses instead of waiting for the third-dose results, it could speed up the timeline for creating baseline immunity in young children.
At the end of the day, even with approval from federal regulators, the real decision in the matter lies with parents.
"The key question is whether the parents of younger children will get their kids vaccinated," Dr. Celine Gounder, a clinical assistant professor at NYU Langone Health, told NPR. "Parents are relatively more hesitant to get their young children vaccinated than themselves."
Pfizer's vaccine was authorized for use in children ages 5 to 11 in October 2021. Yet only 21.6% of children ages 5 to 11 are fully vaccinated, according to the latest data from the Centers for Disease Control and Prevention.
If approval is granted for younger children, Gounder told NPR she expects vaccination rates to mirror that of older children.
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