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Clinics in some states are already immunizing children aged 12-15 with the Pfizer-BioNTech COVID-19 vaccine authorized by the US Food and Drug Administration on Monday, not waiting for final recommendations from a federal vaccine advisory panel.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is meeting today on the use of the Pfizer vaccine in younger teens.
ACIP typically is the final adviser of whether, when, and how childhood vaccines should be given. It also weighs in on adult vaccines, including all three of the COVID-19 shots that have received emergency use authorization from the FDA.
The recommendations from ACIP’s public health and medical experts are not binding but are considered a gold standard, as they weigh all evidence of safety and effectiveness. Payers also generally look to ACIP when considering whether to reimburse for a vaccine. The group’s advice is ultimately used by the CDC director — in this case Rochelle Walensky, MD — to decide whether to give the final yea or nay to the vaccine under consideration.
But it appears 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 Division of Public Health opened four COVID-19-specific clinics on Wednesday and said it would start administering the Pfizer vaccine to children age 12 or older immediately. “Written parental consent is required to vaccinate individuals younger than 18 years old; however, the parent is not required to be on site with the child during the vaccination,” according to a statement from the agency.
“As we look to increase our vaccinated population, especially to reach young people who will be going back to college and school at the end of summer, these new vaccination-only clinics have the capacity to administer thousands of vaccines a week,” said Director Karyl Rattay, MD, in the statement.
The Georgia Department of Public Health also updated its website before ACIP had concluded to note that the Pfizer vaccine was immediately available to anyone age 12 or older.
CNN reported that some parents and children had lined up and received the shot at state-sponsored vaccine sites early 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 FDA’s emergency use authorization for children “is technically not in force until CDC says so.”
“Because vaccine safety is so important, the road to even an emergency use authorization is long,” said Diasio, a pediatrician with Sandhills Pediatrics in North Carolina. “First FDA has to review the data and approve, then ACIP has to approve after looking at the data again, then the CDC has to accept the recommendation from ACIP.”
Then each state decides when to allow administration to 12-to-15 year olds.
Even as the ACIP was deliberating, the AAP issued a statement urging rapid uptake of the Pfizer vaccine.
“The data continue to show that this vaccine is safe and effective,” said AAP President Lee Savio Beers, MD, in the statement. “I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated.”
The AAP noted that almost 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, said AAP.
The organization is recommending that other childhood and adolescent immunizations 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 given together as when they are administered alone, the benefits of co-administration and timely catch up on vaccinations outweigh any theoretical risk,” said AAP.
“We’ve seen the harm done to children’s mental and emotional health as they’ve missed out on so many experiences during the pandemic,” Savio Beers said. “Vaccinating children will protect them and allow them to fully engage in all of the activities — school, sports, socializing with friends and family — that are so important to their health and development.”
Alicia Ault is a Lutherville, Maryland-based freelance journalist whose work has appeared in publications including Smithsonian.com, the New York Times, and the Washington Post. You can find her on Twitter @aliciaault.