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This story has been updated to include the Pfizer/BioNTech submission to the FDA.
Pfizer and BioNTech have submitted a request to the US Food and Drug Administration (FDA) to amend their emergency use authorization for their COVID-19 vaccine to include children between the ages of 6 months to under 5 years old, according to the companies.
The application is for the first two lower-dose (3 micrograms each) vaccines as part of an eventual three-part primary regimen. The companies say they plan to file for the third dose in the coming months.
"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," Pfizer CEO Albert Bourla said in a prepared statement.
The FDA has set a February 15 date for a meeting of its Vaccines and Related Biological Products Advisory Committee to consider the request. While the FDA does not have to follow the group's advice, the agency could authorize the vaccine by the end of the month for this age group.
The Centers for Disease Control and Prevention's vaccine advisory group is also expected to meet to consider the data.
Children under 4 have accounted for 1.6 million COVID cases since the beginning of the pandemic, according to the companies, which prompted the FDA to urge Pfizer/BioNTech to submit the application to begin reviewing data for the two-shot process.
Data supporting the submission is yet to be released. The companies say they plan to admit additional information to the FDA for the third dose in the primary series in the coming months. Pfizer and BioNTech have been testing the third dose for the young age group in recent months. In December, an analysis showed that the two-shot plan is safe but didn't trigger an immune response for ages 2-4 as strong as the one seen in teens and adults. But the two doses did create a protective immune response for children between ages 6 months and 2 years.
A Biden administration official told the The Washington Post that federal health officials are interested in "seeing this move forward." On Friday, Pfizer presented updated clinical trial data to federal health officials about the shots, the newspaper reported.
The American Academy of Pediatrics said parents with children under 5 are facing "an especially challenging moment in this pandemic."
"We understand the urgent need for a safe and effective vaccine for that age group," Mark Del Monte, chief executive of the group, told the Post.
"We are eager to see the data and will continue to follow the science," he said.
Vaccinations among children who are already eligible has been slow, the newspaper reported, and some health officials are worried that it could be even lower for the youngest age groups.
In areas where shots have been available to ages 5-11 since early November, about 28% of children have received at least one dose, according to a new report from the Kaiser Family Foundation. The vaccination rates varied by state, ranging from about 11% in Mississippi to 63% in Vermont last week.
Pfizer/BioNTech press release, Feb. 1, 2022.
The Washington Post: "Pfizer-BioNTech coronavirus vaccine for children under 5 could be available by the end of February, people with knowledge say."
Pfizer: "Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine," Dec. 17, 2021.
Kaiser Family Foundation: "Update on COVID-19 Vaccination of 5-11 Year Olds in the U.S."
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Cite this: Pfizer Asks FDA to Authorize COVID Vaccine for Kids Under 5 - Medscape - Feb 01, 2022.