In a new statement, the FDA warns parents about the risks of vaccinating early.
With kids heading back into the classroom at the same time as the number of COVID-related hospitalizations among children is skyrocketing, it's easy to understand how parents may be tempted to lie about their child's age in order to vaccinate children under 12 who still aren't eligible for the shots.
But the U.S. Food and Drug Administration (FDA) is warning against this so-called "off-label" usage for kids under 12.
Using a vaccine "off-label" means utilizing it for a disease—or in an age group—that it's not approved to treat. (Simply stated, the alternate reason for its use is not on the label.) Off-label usage is legal in most cases, but its application in this manner has not been authorized by the FDA, which can mean it carries some risk.
In a statement released last Friday, Dr. Janet Woodcock, the acting FDA commissioner, and Dr. Peter Marks, of the agency's Center for Biologics Research and Evaluation, stressed that the Pfizer-BioNTech vaccine, authorized for children aged 12 and up, may not be a suitable dosage for younger kids. Nevertheless, numerous reports have surfaced of parents lying about their child's age in order to get them vaccinated early.
When will pediatric vaccines be available?
We still don't know. The earliest estimates slate vaccine availability as soon as October 2021 for kids between ages 5 and 11, though that may be wishful thinking: The wait could be much longer if the authorization process hits any snags. In their joint statement, Dr. Woodcock and Dr. Marks share that the FDA is "working around the clock" to support the process on vaccine availability for children, and understand that the necessity for a pediatric vaccine is a "critical public health need." While they don't have an updated timeline to share, they "hope to have pediatric COVID-19 vaccines available in the coming months."
Pediatric trials are still ongoing, as the FDA requested an expansion of the clinical trials at a late stage, which caused an outcry among medical experts, including the American Academy of Pediatrics (AAP).
"While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group," wrote Dr. Lee Savio Beers, president of the American Academy of Pediatrics, in a letter to the head of the FDA. The letter urged the FDA to speed up the authorization process for children, stating that "the Delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults."
Until the FDA authorizes a pediatric vaccine, parents are left to rely on masking, frequent testing and adult vaccinations to protect their kids from the highly contagious Delta variant. Delta is already responsible for upwards of 5.2 million cases in children—and counting.
Should you lie about your child's age to get them vaccinated?
Say you have an 11-year-old who's a few short months away from turning 12, but they've just started going back to school in person, and case numbers in your region are quickly rising. It's possible to see how a worried parent might fudge their kid's birthdate in order to secure them a shot at their local pharmacy, a few months early—and plenty have.
But because dosing may differ between age groups, getting an off-label shot that's not authorized for your kid's age is still a risk—and potentially an even bigger risk the further your kids are from that age 12 benchmark. "Parents need to remember that the vaccine doses that are currently being studied in younger children are not necessarily the same vaccine doses that were authorized for individuals 12 years and older or approved for individuals 16 years of age and older—there are different dosing regimens being investigated," write Dr. Woodcock and Dr. Marks in the statement.
In truth, there's a big difference between a 7-year-old body and a 12-year-old body, but not that big of a difference between an 11-year-old and a 12-year-old. While the distinction between 11 and 12 may seem arbitrary (in fact, it is—and at least one Canadian province has already started to offer the shots to kids born in 2009 or earlier, which includes 11-year-olds who will turn 12 this year), the trials testing vaccines for the 5 to 12 age group are using a dosage that's one-third the size of the currently available vaccine.
If your child receives too big a dose for their age, there could be a greater risk of serious side effects, including myocarditis and pericarditis, which are rare but serious inflammatory conditions affecting the heart. Cases tend to be more common in younger people, and the expanded trials are specifically looking for these issues in the pediatric population. Pediatric infectious disease specialist Sean O'Leary told Slate that he believes there could be a lower risk of myocarditis and pericarditis if 11-year-olds wait to get the smaller dose.
"It is important for the clinical trials to be completed before vaccinating young kids, so the FDA's team can conduct a thorough evaluation and ensure the data show that the vaccine under consideration is likely to work to prevent COVID-19 in young children and doesn't cause unexpected safety issues separate from those that have already been observed in adolescents and adults," remark Dr. Woodcock and Dr. Marks in the statement.
Weighing the risk of getting COVID versus using an off-label shot
It's an impossible risk-benefit analysis to find your family living in; a version of game theory no one wants to play out till the end. Is the risk of your unvaccinated child contracting COVID greater than the risk of getting an improper vaccine dosage or a serious (albeit extremely rare) side effect?
"As a pediatrician, I would discourage parents from trying to get the COVID vaccine for their children under 12 years of age," says Dr. Neela Sethi Young, who practices in California and is the co-founder of Jaanuu. "The data is still under review and the dosage may even change for the age group. Side effects are being investigated thoroughly. As a parent to two elementary-aged children, I know we all are nervous but we should expect some guidelines for younger children very soon."
For many, news stories of packed hospital ICU wards and ever-increasing COVID case numbers are enough evidence to take drastic—and slightly deceptive—measures. But know that taking these steps could still have drastic results.
"My advice would be to stay the course, be patient—your child's time will come, I promise. In the meantime, mask up and wash those hands. That is the best way to protect our children at this time," Dr. Sethi Young says.
"Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible," write Dr. Woodcock and Dr. Marks. "We have to let the science and data guide us."