Full approval for Pfizer’s coronavirus vaccine means it’s available for what’s known as “off-label” use. That has caught the attention of some parents who have children aged 11 and younger. They’re asking clinicians to give their kids the jab even though the vaccines are not yet authorized for that age group.
With another school year about to begin, many parents are frustrated that children are still waiting for a vaccine nine months after the first shots were cleared for adults.
“People were saying by September, that was going to be the promise for the kids,” says Beth Folsom, of Framingham. “We certainly thought that by the time they went back in the fall that there would be a children’s vaccine that they could at least start to take.”
Folsom has a 17-year-old who is vaccinated and a 9-year-old who is not. Both head back into classrooms next week. Now, with the delta variant surging, Folsom is anxious to get her younger child, Nate, vaccinated. Here’s the pitch she plans to make to Nate’s pediatrician.
It starts with Nate’s height. He's tall for his age, about the size of some 12-year-olds who can already get the shots — so why, Folsom asks, shouldn’t Nate?
Then, there’s the Folsom household. It includes Folsom’s mom who is nearly 80. She’s vaccinated but still at risk for a breakthrough infection. And Folsom wants Nate vaccinated soon so that he’s less likely to get sick and more likely to continue in-person schooling.
“It’s really an issue of trying to balance mental health and that social interaction with the physical health piece,” says Folsom. “I would rather take the risk of potential side effects from a vaccine, which I think are pretty negligible, than having him potentially spread it to others in our household.”
Vaccinating Nate sooner, she says, could also increase protection for everyone in his community.
But getting Nate vaccinated before the FDA authorizes shots for his age group may be a tough sell. The FDA is telling clinicians to wait. And the American Academy of Pediatrics is sending messages to members, trying to preempt off-label vaccination for kids.
“Because there is so much desire, there is a concern that people will jump the gun and start to use it in those younger ages, even though it is not yet ready to be used,” says Dr. Lloyd Fisher, a pediatrician in Worcester and president of the Massachusetts Chapter of the American Academy of Pediatrics. “What we don’t know is the ideal dose.”
Pfizer says its trial for 5 to 11-year-olds gives a third of the adult dose. Everyone younger is getting a 10th of what adults and teenagers receive. The company says it doesn’t comment on off-label use.
Fisher says he’s anxious to start vaccinating younger children himself, but he wants the full confidence that he thinks an FDA decision will provide.
“We have absolutely no reason to believe the vaccine will not be safe and effective for children of all ages, the same as it has been for adolescents and adults,” Fisher says. “However, without having the data to analyze we cannot say that with certainty.”