COVID-19 vaccines could be available for America’s smallest children as soon as June 21, assuming regulatory authorities sign off on the shots next week.
The Biden Administration early Thursday released its plans for distributing low-dose vaccines for children ages 6 months to under 5, the last major group of Americans to receive access to the shots.
As with other groups, the vaccine will be made available for free at pharmacies across the country, but the administration is also making a big push to make the vaccines accessible via pediatricians and primary care providers, children’s museums, libraries, children’s hospitals and health clinics.
Facilities have been able to pre-order vaccine doses since Friday, when the administration released 5 million doses. Another 5 million will be available before June 21 and millions more after, administration officials said, with doses evenly divided among the Moderna and Pfizer-BioNTech vaccines.
First, though, federal advisory committees will review safety and effectiveness data on the low-dose vaccines from both Moderna and Pfizer-BioNTech and decide whether their benefits outweight their risks in young children.
Administration officials, in a Wednesday night call with media, said they were not pre-empting the regulatory process but rather planning for the possibility that the vaccines will soon be authorized.
The vaccines would be identical to those provided to adults, but at a lower dose, one-tenth the adult dose for the Pfizer-BioNTech vaccine and one-quarter of the adult dose for the Moderna vaccine.
Both companies have led studies showing their vaccines are safe and generated a comparable immune response in young children as in older children and adolescents. Moderna tested two doses of its vaccine in children 6 months to 6 years, while Pfizer-BioNTech found that three doses were needed to provide equal protection for children 6 months to under 5 during the current omicron outbreak.
There are no plans to vaccinate children under 6 months of age. Vaccinating pregnant women provides infants with some protection against the virus that causes COVID-19, studies show.
On June 15, an expert advisory committee to the Food and Drug Administration will hold an all-day meeting to review data on vaccines for the youngest children from both companies. (On June 14, the committee will consider authorizing Moderna’s vaccine for children ages 6-17. The Pfizer-BioNTech vaccine has long been available to minors.)
A similar advisory committee to the Centers for Disease Control and Prevention is expected to take up the same topic on June 18, if the FDA commissioner authorizes the shots. (The same procedure will be followed on June 17 for Moderna’s vaccine for children ages 6-17.)
If the CDC director signs off on the shots, they will become available as soon as Tuesday, June 21, officials said. (Monday, June 20 is a federal holiday to celebrate Juneteenth, which commemorates the emancipation of enslaved African-Americans at the end of the Civil War.)
Administration officials said they have focused their planning efforts on making vaccines available as soon as they are authorized and on providing information to families and trusted community leaders, such as pediatricians.
The national public education campaign will include 17,000 volunteers from health care, faith, rural, sports, and youth organizations, as well as national and local organizations.
Shots and educational information will also be made available through existing programs designed to reach young families, including the Women, Infants, and Children Program (WIC), Medicaid and the Children’s Health Insurance Program (CHIP), subsidized housing programs and the Head Start early education program, administration officials said.
Karen Weintraub can be reached at kweintraub@usatoday.com.
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