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 with kids 11 and under. They ask clinicians to give their children the shot, even though the vaccines are not yet authorized for that age group.
As another school year begins, many parents are frustrated that children are still waiting for a vaccine, nine months after the first adult injections were approved.
“People were saying by September that would be the promise for the kids,” said Framingham’s Beth Folsom. “We definitely thought that by the time they went back in the fall, there would be a childhood vaccine that they could at least start taking.”
Folsom has a 17-year-old who is vaccinated and a 9-year-old who is not. Both are going back to class next week. With the delta variant on the rise, Folsom wants to have her younger child, Nate, vaccinated. This is the pitch she plans to give 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 injections — so why, asks Folsom, shouldn’t Nate be?
Then there is Folsom’s household. It includes Folsom’s mother, who is nearly 80. She has been vaccinated but is still at risk of a breakthrough infection. And Folsom wants Nate vaccinated soon so he’s less likely to get sick and more likely to continue receiving personal education.
“It’s really a matter of trying to balance mental health and that social interaction with physical health,” Folsom says. “I’d rather take the risk of potential side effects from a vaccine, which I think is pretty negligible, than potentially spreading it to others in our household.”
Vaccinating Nate earlier, she says, could also increase protection for everyone in his community.
But it may be difficult to get Nate vaccinated before the FDA approves shots for his age group. The FDA tells clinicians to wait. And the American Academy of Pediatrics is messaging members to avoid off-label childhood vaccination.
“Because there’s so much desire, there’s a concern that people will jump the gun and start using it at a younger age, even if it’s not ready to be used yet,” 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 provides a third of the adult dose. Anyone younger gets one-tenth of what adults and teens get. The company says it will not comment on off-label use.
Fisher says he would like to vaccinate younger children himself, but he wants the full confidence that he thinks an FDA decision will give.
“We have absolutely no reason to believe that the vaccine will not be safe and effective for children of all ages, as it will for adolescents and adults,” Fisher said. “But without the data to analyze, we can’t say for sure.”