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Pediatricians may be able to start vaccinating children ages 5-11 years against COVID-19 in a matter of weeks, but they will not be able to use the Comirnaty vaccine vials that are used for adolescents and adults.
The Pfizer-BioNTech vaccine for this age group that is awaiting federal authorization and has gone through clinical trials is a different concentration than the adult version. Children also will receive a different dose — 10 micrograms. Pediatricians soon will be able to order the pediatric vaccine through their jurisdiction.
“We really think vaccinating in the medical home is going to be the best way to get this age group vaccinated,” Amanda Cohn, M.D., FAAP, deputy incidence manager for vaccines for the Centers for Disease Control and Prevention’s (CDC’s) COVID-19 emergency response, said in a call with AAP leaders Wednesday. “This includes pediatric clinics, federally qualified health centers, rural health centers.”
Timeline for pediatric vaccines
Jurisdictions should know by next week how many doses of the Pfizer-BioNTech pediatric vaccine they will be allocated so they can start planning how to distribute them.
The Food and Drug Administration (FDA)’s vaccine advisory committee is scheduled to meet Oct. 26 to discuss emergency use authorization of the COVID vaccine for children, which would be followed by a decision by the FDA commissioner.
If authorized, jurisdictions (states, territories and several large cities) could immediately begin ordering and vaccines will start being delivered to thousands of sites on a pro-rata basis. However, vaccination cannot start until the CDC director makes an official recommendation on how the vaccines can be used. The CDC’s vaccine committee is scheduled to meet Nov. 2-3.
Vaccine supply and ordering
Federal authorities say there will be enough supply to vaccinate all children ages 5-11 years. If approved by the FDA, the pediatric vaccines will be available in 10-dose vials in packages of 10 vials. In the first week after FDA authorization, the minimum pediatric vaccine order will be 300 doses, which will then drop to 100 doses in subsequent weeks. The pediatric vaccines will have an orange cap and label to distinguish them from the adolescent/adult formulation.
The pediatric vaccines will require diluent that will be provided with other supplies for use in children. The vaccines can be stored for 10 weeks in a refrigerator at 2-8 degrees Celsius.
“We’re really hoping that the ultra-cold storage chain issues are no longer a barrier to using the Pfizer product with this longer refrigeration time,” Dr. Cohn said.
The CDC is encouraging jurisdictions to allocate their supply to the providers who work most closely with pediatric populations.
Vaccines also will be distributed to pharmacies, especially in areas with limited Vaccines for Children providers. Pharmacies also will likely help run school- and community-based pop-up clinics.
More than 6 million children have tested positive for COVID-19, according to data from the AAP and the Children’s Hospital Association. In the week ending Oct. 7, there were more than 148,000 new pediatric cases and children made up about one quarter of all new cases.
About 46% of 12- to 17-year-olds in the U.S. are fully vaccinated, according to an AAP report, and the number being vaccinated each week is declining. Dr. Cohn stressed the importance of pediatricians encouraging vaccination.
“We know from all of our research … that a person’s health care provider, pediatricians, are a parent’s most trusted source of health care information,” Dr. Cohn said. “And a strong recommendation by a pediatrician for their child to get a COVID vaccine is directly related to uptake in that person.”
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