Almost as soon as the news broke Monday that the Food and Drug Administration (FDA) had given full approval to Pfizer-BioNTech’s COVID-19 vaccine, social media erupted with questions about if the FDA’s approval would clear the path for kids under 12 to access the vaccine.
The approval, the first formally granted for a COVID vaccine in the United States, applies to people ages 16 and older, though an emergency authorization remains effective for children ages 12 to 16. That still leaves parents for young kids searching for answers.
Some parenting groups on Facebook almost immediately began to try to source out willing pediatricians in their area who might be able to vaccinate their children — many of whom are attending schools in mask-optional environments. They wondered whether the FDA approval of the Pfizer vaccine now provides a workaround for allowing children under the age of 12 to get vaccinated through off-label usage at the discretion of pediatricians. Off-label usage of FDA-approved medication is common in pediatrics; relative to adults, there is less data on dosage, safety and efficacy for many medications when used in children, which is why a culture has emerged of pediatricians using their best judgment and first-hand experience in sometimes prescribing something not indicated for use in a pediatric population for children. Because of the way in which this is increasingly becoming common practice, parents know to ask about off-label usage — and many even expect it.
Dr. Cameron Webb, a member of the White House’s COVID-19 Response Team, told The 19th that it’s better to wait for emergency use authorization (EUA) for the under-12 COVID vaccine than take the leap into off-label usage of the full authorization adult version. Webb said that while technically, the FDA approval does mean that the Pfizer vaccine can in fact be prescribed off-label, it’s important to remember that the dosage being administered for children under clinical trial is one-third of that for adults. That means off-label use of the FDA-approved vaccine would likely involve delivering an amount of dosage that has not yet been researched in children under the age of 12.
“My 10-year-old and 6-year-old just went back to school today,” Webb said. “I share the thoughts and concerns of parents sending kids to school in a pandemic, especially mid-Delta surge. I’ve had colleagues — other physicians — who have reached out to me today to ask if they can get an off-label dose for their child at this point.”
But Webb advises waiting, especially given the FDA’s move to hold off on emergency use authorization for ages 5 to 11 until more children could be enrolled in the Phase 3 clinical trials. One leading reason, he said, is to ensure that children are not at increased risk for myocarditis, an inflammatory heart condition. A statistically insignificant number of cases of myocarditis have been seen thus far in clinical trials of the COVID vaccine in kids; the condition also affects children who have contracted COVID, albeit rarely. It’s why, out of an abundance of caution, the FDA is asking vaccine makers for more enrollees to better understand the likelihood of this side effect.
“For people who are worried about kids’ safety and wellbeing and want to see them vaccinated, they also need to trust science and the rigorous review process,” he said. “Yes, we’re in a race to get [vaccines for children] available, ASAP, but we want to make sure it is safe for kids.”
For parents wondering if Monday’s FDA authorization means that we’re that much closer to children under 12 being able to access the vaccines, Webb reminded that full authorization “is a separate process and review” system than a process that would allow for emergency use authorization.
“We want our kids to have the same standard of rigorous review that there was for us to get the vaccines,” Webb said. “I know a lot of parents who are eager — we all wanted vaccines in kids’ arms five weeks before we went back to school, but the truth is that whatever is administered to kids is something we want to meet the highest standards of efficacy and safety.”
Webb also explained that given the surge of the variant — and the White House’s announcement last week about making booster shots available — vaccines have never been more important. Full FDA authorization confirms that vaccines work and well, and boosters are a testament to this. “The data shows that the Pfizer vaccine that got FDA approval is effective against the Delta variant. Delta moves faster and causes folks to be sicker. That’s great news. The vaccine still works against Delta.”
He added that research currently indicates that the Pfizer vaccine is 88 percent effective in protecting against infection from COVID in light of the Delta variant — a number he calls “still extremely good, but not quite as strong as it was before.” What people should understand from these numbers is that “we need to do everything we can to stop the virus from creating variants” — namely, ensuring that as many people as possible are vaccinated.
“The White House announced the booster plan because there have been some signals that the vaccine loses some effectiveness over time, and this plan was reviewed by the FDA and the Advisory Committee on Immunization Practices,” Webb said. “But in the meantime, for people thinking about getting vaccinated, it is the best way to protect against this variant. The best way to protect against this virus is to get vaccinated.”