There is currently no COVID-19 vaccine that has been authorized in any way for use in children under the age of 12, something that’s of increasing concern to many parents who are sending their young kids back to school amid the swift spread of the highly contagious delta variant. The Food and Drug Administration’s full approval of the Pfizer-BioNTech vaccine — which came on August 23 — offered these parents a brief glimmer of hope: Typically, vaccines or drugs that are fully FDA approved are eligible for off-label use, which means doctors could choose to give the life-saving shots to someone who’s outside of the approved population. Some hoped that this news meant that doctors would begin administering the two-dose COVID-19 vaccine to all children, including those younger than age 12.
But although it may be legally permissible to give the shot off-label, the Centers for Disease Control and Prevention, the FDA, and the American Academy of Pediatrics are recommending against vaccinating children who are 11 or younger until more data has been collected about how to do so safely, and are even reprimanding doctors who use the vaccine off-label.
"We do not have data on the proper dose, nor do we have the full data on the safety in children younger than what is in the EUA, and so that would be a great concern that people would vaccinate children," FDA commissioner Janet Woodcock, MD, said in a press briefing. "We are not recommending that children younger than age 12 be vaccinated with this vaccine, it would not be appropriate." She added, “They are not just small adults.”
The FDA approval of the Pfizer vaccine (now officially named Comirnaty) was granted for people aged 16 and older. This means it isn’t yet fully approved for children ages 12 to 15. But this age group is still able to receive the Pfizer shots, because the vaccine was granted emergency use approval for those 12 and up. In fact, the CDC recommends everyone 12 years and older get vaccinated for COVID-19. The concern around off-label use in children is for those under age 12.
Shortly after the news of the FDA’s full approval broke, there were reports of parents of children under the age of 12 calling their pediatricians and even using Twitter to ask if their kids could receive the shot off-label. In reference to getting her kids an off-label vaccine, one parent of 11-year-old triplets told The Wall Street Journal that “if there is a way to get around it legally, I am so there.”
Hannah Lichtsinn, MD, a pediatrician and internal medicine practitioner in Minneapolis, MN, says she understands where parents are coming from. “As a parent of young kids, I want to protect my kids from harm, injury, and sickness, and also really want them to be able to go to school and stay in school this year, because they missed so much of it last year,” Dr. Lichtsinn says. “That desire is what’s driving parents and their doctors to explore every possible way to keep kids healthy during this pandemic.” Even so, Dr. Lichtsinn isn’t surprised by the guidance to wait for more trial data before making vaccines available to younger kids.
With FDA approval this week of the Pfizer vaccine there has been some discussion of “off label” use in kids. I think this is worth talking about but first we need to break it down. A brief 🧵1/8— Hannah Lichtsinn, MD (@DoctorLix) August 22, 2021
Trials into vaccine safety and efficacy among children are currently underway, and safety data is expected to be available in September 2021. Many experts, including Dr. Lichtsinn, believe the trial data will confirm that the vaccine is safe for kids ages 5 to 11 — but it’s also likely that children in this age group will need a smaller dose than older groups, in part due to their smaller body size but also because children tend to have a more robust immune response than adults. “The trials that are being done in children, those phase one trials, looked at a variety of different doses to see which worked best, so the dose will no doubt be different in younger children than in adolescents,” says Paul A. Offit, MD, director of the Vaccine Education Center and a professor of pediatrics in the division of infectious diseases at the Children’s Hospital of Philadelphia.
“The reason why the American Academy of Pediatrics cautioned against [giving the vaccine off-label to children under age 12] is that they’re trying to avoid, one, the inundation of parents calling pediatricians to ask for this, and, two, the burden that it will present to doctors to have to do dosing and dosing schedules a la carte,” says Jessica Malaty Rivera, an infectious disease epidemiologist and a research fellow at Boston Children's Hospital. “It could be very cumbersome and possibly dicey to not have it standardized.”
I'm super concerned that #pediatricians are not going to be able to handle the volume of inquiries for #offlabel #vaccine for kids <12. They need to prioritize kids at high risk and kids that live with others who are #HighRiskCovid19 first@willhumble_az @AZDHS @CDCgov— MsMindful_RN (@MsMindfulBlog) August 23, 2021
“The good news is these trials are ongoing, very high priority, and I am optimistic that we will not have to wait much longer to have high-quality evidence that says this is safe in kids,” says Paul Pottinger, MD, a professor specializing in infectious disease at the University of Washington School of Medicine. “It is unfortunate that we’re not quite there yet, especially as schools are reopening. But that information is coming soon.”
While there is some precedent for the off-label use of vaccines, it typically occurs when doctors choose to give a vaccine to someone just outside of the approved age range — say, someone who’s 51, when the approved age range is under 50, says John D. Grabenstein, PhD, the general manager of Vaccine Dynamics, editor for Immunization Action Coalition, and an expert on the COVID-19 Vaccine Analysis Team. Malaty Rivera says she has heard from parents of kids who are 11 years old wondering about getting the vaccine off-label.
“I think it would be very reasonable to vaccinate someone who’s 11-and-a-half, or 11-and-three-quarters [years old],” Dr. Lichtsinn says. “There’s no reason to think that the vaccine will behave any differently in a child that age than in one who’s just had their 12th birthday.”
Dr. Pottinger agrees that the cut-off ages can feel “arbitrary” — and in some ways, they are, considering that children develop at different rates. “But this is the way that the studies were designed,” he stresses. “It’s biologically likely and plausible that an 11-year-old would do fine, and that’s not the way that the studies were done, so we have to respect that science, respect the regulatory process, and understand that soon enough, I’m very hopeful, we will have this technology for 11-year-olds."
While Dr. Pottinger suggests that parents of children with compromised health, or who are members of a family with medical considerations talk to their pediatrician about their options, there’s likely not much their doctors will be able to do. Although off-label use of the Pfizer vaccine may be “legally permissible,” providers who use the vaccine off-label will effectively be censured by the CDC. “Clinicians who administer COVID-19 vaccines off-label to children under 12 years would be violating their provider agreement, risking liability for adverse events, and potentially forfeiting payment,” the American Academy of Pediatrics noted. A doctor who prescribes off-label is leaving themselves at risk for being sued, and could lose their eligibility to be in the CDC’s COVID-19 vaccination program, meaning they may no longer be able to administer vaccinations to anyone, The Wall Street Journal reports. Dr. Pottinger adds that although the system and regulations can be frustrating to some parents, the process is safe, it works, and rules are there for a reason.
Congratulations! If anyone knows of pediatricians willing to give Pfizer off label (we have a high risk kid) please DM me! https://t.co/sVuQ6naymC— Amy Kiefer (@amykatherine) August 23, 2021
Malaty Rivera says that while she could see there being some wiggle room for someone who’s 11-and-a-half years old, she wouldn’t recommend parents try to persuade their pediatrician to administer an off-label shot. “When we’re talking about little kids, mine are 4 and 3, and I don’t feel comfortable yet asking for an off-label prescription, I’d rather enroll my kids in a clinical trial that’s still enrolling if I could, or wait until the authorization comes through,” Malaty Rivera says. She adds that when the Pfizer vaccine is given an emergency use authorization, as experts expect it will, high-risk or immunocompromised children should be prioritized.
While some parents will likely not want to wait, the good news is that September — when the trial data is expected to be available — is only a few short weeks away, so hopefully we’ll know more about when younger children will be eligible for vaccination soon. Until then, Dr. Pottinger says, “the most important thing parents can do is get immunized themselves, and ensure and insist that in their school environment, everyone eligible to get immunized is, in fact, immunized.”