Just hours after the Food and Drug Administration announced full approval for the Pfizer/BioNTech Covid-19 vaccine on Monday, the American Academy of Pediatrics issued a warning: Physicians should not vaccinate any children under the age of 12 “off-label.”
But by that time, parents had already started calling their pediatricians. Full FDA approval of a drug or vaccine opens the door for off-label use, when doctors can use their discretion to provide a treatment in a way other than what it’s specifically approved for — in this case, people age 16 or older. In Raleigh, North Carolina, Patti Mulligan spoke to an administrative employee and easily made a Wednesday appointment for her 9-year-old daughter. When they showed up, they were turned away because the practice had decided not to provide off-label vaccinations.
“She was really looking forward to getting the shot,” Mulligan said of her daughter. “She’s tired of worrying about it.”
Pediatricians across the country are heeding the recommendations to wait, echoed by the FDA and Centers for Disease Control and Prevention. They’re concerned about attempting to find the right dosage on their own, given that kids will likely need a different dose, or facing potential liability issues. The CDC says providers who vaccinate off-label may be violating the agreement they signed to provide Covid-19 vaccines and also says providers who vaccinate off-label may also lose immunity under the PREP Declaration, which protects health care providers from liability claims in emergencies like the pandemic.
“I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials,” said Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed.”
Pfizer vaccine trials for children under 12 are ongoing, and experts urged clinicians to wait for the data, which is expected to be reported this fall. Pfizer has said it plans to submit a request to extend its emergency use authorization for kids 5 to 11 by the end of September. Currently, children ages 12 to 15 can get a shot under the vaccine’s emergency use authorization.
The recommendation to continue waiting frustrates parents who worry about their children’s lack of protection against the virus, especially as school is getting back in swing. In the district Mulligan lives in, there were 140 positive cases in just the first two days of classes.
“I feel like we’re just playing Russian roulette,” Mulligan said.
Brian Kendall, an emergency room physician at University Medical Center in Lubbock, Texas, has been waiting anxiously for his two kids, ages 3 and 9, to be able to get a vaccine. To protect them from his own potential exposure at the hospital, he still doesn’t let them hug him when he comes home from work until after he’s changed his clothes.
When he called the pediatrician on Monday to ask about off-label vaccination, the office said they weren’t ready to provide them. He later read the AAP recommendation.
“I thought, you know what? That makes a lot of sense,” he said. Still, if his pediatrician was willing to do it and considered the dosage carefully, “I think we may have still gone through with it.”
Other parents online have lamented a lack of nuance in the guidance; what’s the difference between a small 12-year-old and a taller, heavier 11-year-old that allows one to be vaccinated and not the other?
“I think that a blanket statement that no doctors should be doing this is actually incredibly irresponsible,” Mulligan said.
Pediatricians say they understand the frustration and fear among parents.
“The Delta variant surge obviously is a tremendous concern for parents,” said Flor Munoz-Rivas, an infectious disease physician at Texas Children’s Hospital in Houston and site principal investigator for the Pfizer trial in children under 12.
She splits her time between administering and observing the vaccine in young children in the trial, then treating patients who have been infected with Covid-19. Her hospital has seen soaring numbers of children coming in with Covid-19. While the data is still being collected on vaccinations in younger kids, she said, there are other safety measures — such as masking and vaccination of anyone who is already eligible — that should be taken.
“It’s not justifiable to rush to offer a vaccine off-label at this point,” she said.
Few pediatricians seem willing to consider exceptions to the recommendation. Mark Schleiss, who runs a pediatric infectious diseases and immunology lab at the University of Minnesota tweeted days before the FDA approval that he supports off-label use of the vaccine for children, though he later clarified in an interview that he supports the AAP’s position that the vaccine should not be given off-label to kids.
“Having said that, I definitely support the continued dialogue thinking about the off-label indications. And I would be empathic and supportive of clinicians who, under exceptional circumstances, might want to use the drug off-label,” he said.
If there are pediatricians vaccinating children off-label, they may not be advertising it. Still, Jacob Sherkow, a bioethicist and law professor at the University of Illinois, said it’s highly likely at least some doctors are offering the vaccine to younger children already.
“One thing the pandemic has taught me is that there are rogue physicians everywhere,” he said.
Until there’s more data to support extending the emergency authorization to kids, families will need to continue to protect themselves as best they can. Kendall said his 3-year-old daughter has already been exposed to the virus at school. All he can do is continue the same precautions he’s taken for a year and a half.
“It’s sad when I walk in the door and my daughter squeals ‘Daddy,’ and starts running towards me,” he said. “I do miss the ability to have them run towards me and then throw them up in the air and give them a big hug.”