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Within days of when regulators clear the nation's first COVID-19 vaccine for younger children, federal officials say they will begin pushing out as many as 20 million doses of pediatric Pfizer-BioNTech to inoculate school-age kids across America in another bid to control the pandemic.
The kickoff of the children's vaccination campaign could begin as soon as early November. And this time round, the government has purchased enough doses to give two shots to all 28 million eligible children, ages 5 to 11.
Still, federal and state officials and health providers say that vaccinating children is likely to be an even more challenging process than it has been for adults and teens. The federal government plans to allocate shots in the initial rollout according to a formula ensuring equitable distribution, likely based on a state's population of eligible children, according to a federal health official. And enlisting besieged health providers and persuading reluctant parents will complicate the process.
"Everyone is so busy right now. Kids have gone back to school, we're seeing disease increases in pediatrician offices because of exposures to other viruses and we're needing (children) to come in for flu vaccine," said Patsy Stinchfield, a former senior director of infection prevention and control at Children's Minnesota, a pediatric health system in St. Paul and Minneapolis.
Clinicians are still completing coronavirus vaccinations for those 12 and older, giving third shots to immunocompromised individuals, and boosters to older adults and others at high risk for severe disease.
The efforts to clear the nation's first vaccine for younger children moved into high gear this week when Pfizer and BioNTech filed a formal request with the Food and Drug Administration to authorize a regimen of two 10-microgram doses in 5- to 11-year-olds — one-third the amount given those 12 and older.
An FDA expert panel is scheduled to hear presentations on the vaccine's safety and efficacy Oct. 26, with advisers to the Centers for Disease Control and Prevention meeting a few days later. If regulators and the CDC give the go-ahead, children could start getting the shots the first week of November.
"We're ready, we have the supply," said Jeff Zients, the White House coronavirus response coordinator, appearing on CNN. "We're working with states to set up convenient locations for parents and kids to get vaccinated, including pediatricians' offices and community sites. We'll be ready pending the CDC and FDA action."
But the government initially will distribute only a portion of the 65 million doses the government has purchased, according to a senior federal health official who spoke on the condition of anonymity. Up to 20 million doses will be available the first week, the official said. Federal officials are "also making sure that we're not having folks unnecessarily stockpile product."
That's one of the reasons the first doses are expected to be allocated according to a formula, most likely based on a state's population of eligible children, according to information shared this week with state officials. Once the vaccines go out, it will be up to state officials to decide where and how many doses should go to pediatricians, pharmacies and school clinics.
In a Wednesday conference call with CDC officials, immunization officials were told there would be vaccine allocation, but were given few specifics, said Claire Hannan, executive director of the Association of Immunization Managers, who took part.
While overall supply may be sufficient, Hannan said, a key challenge will be ensuring the children's vaccine can be shared with all the providers who may want to administer it. Pfizer's packages contain 10 vials, each with 10 doses, for a total of 100 doses. The size of those packages will make it hard to share the vaccine with many providers, she said.
"If you have 100 kids across one county, you can only send one package of those 100 doses somewhere," Hannan said. "That's not really what I consider sufficient. If they were single-dose vials, you could spread them around."
And unlike adults and teens accustomed to getting their shots at national pharmacy chains, which can store and administer large numbers of doses, many parents of younger children will prefer to bring their children to their pediatricians' offices, which may not have that capacity.
"Everyone does recognize that for younger kids, the pediatric office is the trusted place for vaccines," said Lee Ann Savio Beers, president of the American Academy of Pediatrics. But key details "is not yet clear to us," she said. "We hope to hear soon, exactly how that is going to happen."