Are Off-Label Prescriptions a Backdoor to Giving Kids Covid Vaccines?

The Food and Drug Administration’s decision to give full approval to the Pfizer Covid vaccine was only a few hours old last week when groups on Facebook lit up with questions. The move changed the vaccine’s availability in the marketplace, triggered business and military vaccine mandates , and may have altered its acceptability to vaccine-hesitant people.But that was only for people 16 years old and up. For teens 12 to 15, the FDA left the Pfizer formula under emergency authorization. For children younger than 12, it kept the vaccine entirely off-limits until the conclusion of kids’ clinical trials , which are now due sometime in late fall. That immediately ignited debate among parents about whether they could find a way to get younger kids the shot, as well as whether they should.

“My child is almost the size of a 12-year-old,” began one thread in a private group. “I’m calling my pediatrician tomorrow,” began another. A third person floated a rumor: Someone took their child to a pharmacy and accidentally wrote the wrong birthdate on the vaccine paperwork.

Parents weren’t the only ones talking. Online circles of physicians and scientists fired up just as fast, arguing the ethics of administering the vaccine outside the bounds of the approval—through a process called “off-label” prescribing—versus waiting for data and for the FDA to rule. Off-label use, or prescribing a drug for a purpose or in a population not studied during its approval process, is legal to do, and it is especially common in pediatric medicine, since many older drugs still on the market were never studied in children.

But this case is trickier than normal, as online disagreements made clear. “We need more knowledge here, but kids are dying in this once-in-century catastrophe. I support off-label use in children under 12,” a pediatric infectious disease specialist in Minnesota posted on Twitter, while one in Indiana countered: “I'm eager for kids (under) 12 to get a Covid-19 vaccine, but feel we must have the Phase III data and an FDA EUA or approval first.”A week later the chatter hasn’t died down, and there isn’t much more clarity. The Advisory Committee on Immunization Practices, the outside committee that advises the Centers for Disease Control and Prevention on new drugs, met Monday but did not discuss child vaccination. Meanwhile, CDC data released last week made clear that, as more adults get vaccinated, children account for a larger proportion of those falling ill. And some are becoming seriously ill: Almost one-third of 12- to 17-year-olds who have developed Covid since March 2020 have required intensive care, the agency reported, and 5 percent of those needed to be put on ventilators.
With schools opening, mask-wearing unenforced (and in many places forbidden), and the Delta variant cresting everywhere, the question of being able to vaccinate kids feels like a synecdoche for the whole Covid response: a landscape of unclear risk in which policy is insufficient to clarify how much danger people—or their kids—are in.The vaccine approval for adults but not for children leaves pediatricians and pharmacists in an uncomfortable position. Their professional obligation to be gatekeepers—to decline to order a drug or honor a prescription if they do not think it is justified—feels at odds with their professional goals of keeping patients healthy and safe. Saying no to worried parents is “not only hard, it's heartbreaking,” says Hina J. Talib, a pediatrician and adolescent medicine specialist at the Children’s Hospital at Montefiore in the Bronx. “Because we are the ones, as pediatricians, who consistently have been trying our best to put kids first in this pandemic. And it’s certainly tempting to us as parents as well. We want to protect children, so we want to protect our children too.”