Alaska has ordered pediatric COVID-19 vaccines in anticipation of FDA, CDC approval

ANCHORAGE, Alaska (KTUU) - The state of Alaska is preparing for the expected approval of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 in coming days. The vaccine could be available as early as next week, if approved, said Alaska Chief Medical Officer Dr. Anne Zink.

An advisory panel to the Food and Drug Administration voted Tuesday to endorse child-sized doses of the vaccine for children 5-11. The advisory panel was unanimous with one abstention. The FDA is expected to make a decision on the recommendation within days.

Advisers raised concerns that an approval of the vaccine would lead to mandates by states and school districts, while the risk of certain conditions like myocarditis, an inflammation of the heart, is unclear in that age group.

“I’m just worried that if we say yes, that the states are going to mandate administration of this vaccine to children in order to go to school and I do not agree with that,” said FDA Adviser Dr. H. Cody Meissner. “I think that would be an error at this time until we get more information about the safety, so I think I agree with what everyone else is saying here, we’re in a very difficult decision-making process.”

Other advisers said the benefits of vaccines, including keeping children in school, outweigh the risks, but that studies of the vaccines’ impacts needs to continue.

“The school closures and the disruption I think has been enormous, and I think we have to weigh that against the benefits that we would see for the vaccine,” said Dr. Jeannette Lee. “And I definitely think the benefits outweigh that. But obviously we’ll have to follow these kids for some time to see how that happens.”

Among the 2,200 trial participants, none experienced myocarditis, pericarditis or anaphylaxis after the vaccine, and no participants died, according to the executive summary shared with the FDA’s panel. Myocarditis has been observed more commonly in adolescent boys and young men after the second dose of the vaccine.

A study of myocarditis in COVID-19 patients marked the risk for the condition among males 12-29 to be 39-47 cases per million second doses, and found that people of all ages were more at risk of myocarditis with diagnosed COVID-19 than without it. Among hospitalized patients, COVID-19 patients were 16 times more likely to have myocarditis than those without COVID-19, the study found.

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Next Tuesday and Wednesday, the Centers for Disease Control and Prevention’s Advisory Commission on Immunization Practices will meet about whether to recommend the shots, and for which children. The CDC’s director then decides whether or not to approve that recommendation as an extension of Pfizer’s Emergency Use Authorization. The Pfizer-BioNTech version of the vaccine is already fully approved by the FDA and CDC for those 16 and older. Those age 12-15 are able to get the Pfizer vaccine under Emergency Use Authorization.

The state of Alaska has ordered 33,000 pediatric vaccine doses already. The Pfizer vaccine dose for children is 10 micrograms, one-third the dose given to adults and adolescents 12 and older. Dr. Jeffrey Demain, a private practice immunologist in Anchorage, says unlike medications, vaccines aren’t based on weight, and a child’s dose is smaller because children naturally build a more robust immune response.

“It’s been calculated with using a lower dose. For example with Pfizer, instead of using 30 they’re using 10 micrograms and that’s going to get the same response as we’d see with a 30 dose in an older child or an adult,” Demain explained in a virtual question and answer session Wednesday. “So it’s really based on age, not weight or size.”

Zink says the state’s pediatricians and family physicians are signing up to distribute the vaccines to their patients.

“Many other states have really struggled to have their traditional pediatricians or family practice docs be enrolled as COVID-19 providers, but our state has had great uptake there,” Zink said late last week. “We’re really excited to have pediatricians, family practice doctors, nurse practitioners, who traditionally give our kiddos vaccines, also be enrolled as COVID-19 providers.”

Zink said it’s possible the shots could be available to Alaska children on Nov. 4, the day after the CDC’s advisory commission meets, as CDC Director Dr. Rachelle Walensky is expected to make an authorization decision quickly.

The state already has orders from providers, and says the child dose availability will be noted on vaccine sign up sites. Private practice physicians, pharmacies and vaccine events will be available for Alaskan families.

The series for children is two doses, 21 days apart. Pediatricians are urging Alaskans to consider holiday travel destinations if that’s a factor in their timeline. Dr. Mishelle Nace, a Fairbanks pediatrician, cautions that some clinics may not offer vaccines in the first week of availability because the third week, when children would be ready for a second dose, is the week of Thanksgiving. She said Nov. 13 is roughly the latest date to get a first dose, in order to be fully vaccinated by the time schools let out for winter break in late December.

State vaccine data shows that about 41,200 Alaskans age 12-19 have at least one dose of a COVID-19 vaccine. Zink said for kids age 12-18, 52.1% have one dose or more, and 46.43% in the state are fully vaccinated. Currently, Pfizer is the only manufacturer’s dose authorized for use in children under 18.

The Anchorage School District says it plans to host vaccine clinics at the district’s Education Center in Anchorage, similar to earlier vaccine clinics held there for community members. A spokesperson said the clinics will be open by appointment and to walk-ins, during evenings and weekend hours. The dates of the planned clinics are not yet available.

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