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Clinics in some states are already immunizing 12- to 15-year-olds with the Pfizer-BioNTech COVID-19 vaccine authorized Monday by the U.S. Food and Drug Administration on Monday, without waiting for final group recommendations federal vaccine advisory.
US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) meets today on the use of the Pfizer vaccine in younger adolescents.
ACIP is usually the final advisor on whether, when and how childhood vaccines should be given. It also affects adult vaccines, including all three COVID-19 vaccines that have received FDA emergency use authorization.
The recommendations of ACIP medical and health experts are not binding, but they are considered a gold standard, as they weigh all safety and efficacy tests. Payers also often look to ACIP when considering whether to reimburse a vaccine. The group board is ultimately used by the CDC director (in this case Rochelle Walensky, MD) to decide whether or not to give the last yes or no to the vaccine being considered.
But it seems that some states had so few concerns about the Pfizer vaccine that they began offering it to patients before ACIP had issued its recommendations.
The Delaware Public Health Division opened four specific COVID-19 clinics on Wednesday and said it would begin administering the Pfizer vaccine to children 12 years of age or older immediately. “Written parental consent is required to vaccinate people under the age of 18; however, parents are not required to be on site with the child during vaccination,” according to a statement of the agency.
“As we try to increase our vaccinated population, especially to reach the young people who will return to college and school in late summer, these new exclusive vaccination clinics have the capacity to deliver thousands of vaccines a week.” , said director Karyl Rattay, MD, in the statement.
The Georgia Department of Public Health as well has updated their website before ACIP had concluded to point out that the Pfizer vaccine was immediately available to anyone 12 years of age or older.
CNN reported that some parents and children had lined up and had been shot at state-sponsored vaccine sites in the early hours of this morning.
Jumping the line
But Christoph Diasio, MD, speaking on behalf of the American Academy of Pediatrics (AAP), noted in a comment to Medscape Medical News that the FDA’s emergency use authorization for children “is technically not in effect until the CDC says so.”
“Because vaccine safety is so important, the road to an emergency use permit is long,” said Diasio, a pediatrician at Sandhills Pediatrics in North Carolina. “First the FDA has to review the data and approve it, then the ACIP has to approve it after re-examining it, and then the CDC has to accept the ACIP recommendation.”
Then, each state decides when administration to children ages 12 to 15 is allowed.
Although the ACIP was deliberating, the AAP issued a statement instant to the rapid release of the Pfizer vaccine.
“The data continues to show that this vaccine is safe and effective,” AAP President Lee Savio Beers, MD, said in the statement. “I urge all parents to call their pediatrician for more information on how to vaccinate their children and teens.”
The AAP noted that nearly 4 million children have been infected with the SARS-CoV-2 virus since the beginning of the pandemic and that thousands have been hospitalized. Hundreds have died, AAP said.
The organization recommends that other vaccines for children and adolescents be given at the same time as COVID-19 vaccines. “Between the substantial data collected on the safety of COVID-19 vaccines and the extensive experience with non-COVID-19 vaccines, which shows the immune response and side effects, are generally similar when vaccines are administered together as when administered alone, the benefits of co – administration and updating of vaccines outweigh any theoretical risks, “AAP said.
“We have seen the harm done to the mental and emotional health of children as they have lost so many experiences during the pandemic,” Savio Beers said. “Vaccination of children will protect them and allow them to participate fully in all activities (school, sports, socializing with friends and family) that are so important to their health and development.”
Alicia Ault is a freelance journalist based in Lutherville, Maryland, whose work has appeared in publications such as Smithsonian.com, the New York Times and the Washington Post. You can find her on Twitter @aliciaault.
