WASHINGTON – Within days of regulators clearing the nation’s first vaccine for younger children, federal officials say they will begin pushing out as many as 20 million doses of the Pfizer-BioNTech pediatric vaccine to inoculate school-age kids across America in a bid to control the coronavirus pandemic.
The kickoff of the long-awaited children’s vaccination campaign is expected 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 a more challenging process than it was for adults and teens. The federal government plans to allocate the initial shots according to a formula to ensure equitable distribution, likely based on a state’s population of eligible children, according to a federal health official who spoke on the condition of anonymity to share planning. 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.
“And now this population. Phew,” Stinchfield said. “There is great worry about how the United States will manage the new wave of kids coming in for covid vaccines.”
The long-running 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 to those 12 and older. An FDA expert panel is scheduled to hear presentations on the vaccine’s safety and efficacy Oct. 26, with vaccine advisers to the Centers for Disease Control and Prevention meeting Nov. 2 and 3. If regulators and the CDC give the go-ahead, the shots could start being administered almost immediately.
“We’re ready, we have the supply,” said Jeff Zients, the White House coronavirus coordinator, appearing Thursday 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..”
But the government will initially distribute only a portion of the 65 million doses it has purchased, according to a senior federal health official who spoke on the condition of anonymity to share planning discussions. 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,” the official said.
In a memo sent to state immunization officials late Friday, the CDC said there would be an initial “large one-time bolus of pediatric product . . . made available pro rata for jurisdictions to order. This will ensure that vaccine can be placed in thousands of locations nationwide making it easier for children to get vaccinated.”
The memo offered no numbers and did not lay out how the pro-rata allocation would work.
The CDC said providers who are most likely to vaccinate children “should be prioritized for initial dose availability,” including pediatric clinics, federally qualified health centers, rural health centers, and pharmacies.
Still, many questions remain unanswered only weeks from the possible launch.
“How do you get clinicians to want to participate in the program? What will the role of pharmacists be? What will the role of schools be? How will we help parents get their questions answered quickly and by whom?” said Michael Fraser, executive director of the Association of State and Territorial Health Officials.
Such questions are of particular concern at a moment when many health systems and clinicians’ offices are slammed, with many health-care caregivers in their 19th month on the pandemic’s front lines.
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 containing 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 information about dose distribution and other key details “is not yet clear to us,” she said. “We hope to hear soon, exactly how that is going to happen.”
Federal health officials say they have scheduled meetings in the coming days to discuss vaccine preparations with AAP leaders and pediatric provider groups.
Meanwhile, school-based clinics, often used for children’s flu vaccination, take six to eight weeks of planning, said Tiffany Tate, executive director of the Maryland Partnership for Prevention, a nonprofit that works on childhood and adult immunizations.
“Are we going to have covid and flu clinics at the same time? Are we going to do flu and then covid? And how do we get consent forms for everyone? It’s a lot of logistical challenges,” Tate said.
Storage, handling and administration requirements are different for coronavirus and flu vaccines, she said. While the challenges are not insurmountable, Tate said, “You can’t just show up with needles and nurses.”
Planning has also been made more difficult because of unanswered questions about whether providers can administer the existing Pfizer product at the smaller dosages for children younger than 12.
Some large pediatric practices, for instance, had planned to pull child-sized doses from existing Pfizer-BioNTech vials for vaccination clinics and were surprised to learn this week that Pfizer is discouraging that. Pfizer spokesman Kit Longley said the company will be shipping separate pediatric vials, with unique labels and different color caps to distinguish those from the vials used for those 12 and older.
“The lack of disseminated information is frustrating,” said Marc Lashley, a pediatrician who heads coronavirus vaccinations at New York-based Allied Physicians Group, one of the largest pediatric groups in the country with about 180,000 patients.
He said Allied may have to delay or cancel its plans to turn 2,000 adult doses into 6,000 pediatric doses for a vaccination clinic if it cannot use existing vaccine and is unable to get the new formulation quickly.
Even as he expressed disappointment, Lashley said in an email that “we are grateful to have a vaccine to use in children at all, and we are looking forward to implementing it as soon as possible.”
Federal health officials said that some answers must await the completion of the regulatory process.
“That process has to happen before you can give the kind of precise, direct guidance that people are going to need,” the senior federal official said.
But they note the CDC has enrolled tens of thousands of providers around the country – more than 70% of clinicians who are part of a federally funded program that provides vaccines at no cost to children – into the covid-19 vaccination program.
The Health and Human Services and the Education departments also plan to run a “robust messaging/outreach campaign” to encourage vaccination for children, the official said.
Some families won’t need such prodding. For them, the availability of children’s vaccines can’t come soon enough amid a sharp increase in serious covid-19 infections among school-aged children.
But others are likely to have questions and move more deliberately. A survey last month from the Kaiser Family Foundation found about one-third of parents of children in the age group – roughly 9 million kids – wanted their child to get vaccinated “right away” once they became eligible. A similar share said they would wait and see, and about a quarter said their children will “definitely not” get a coronavirus vaccine.
CDC spokeswoman Kristen Nordlund said the agency expects to send more information about pediatric vaccine implementation in the coming week.
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The Washington Post’s Laurie McGinley and Dan Keating contributed to this report.