The school year rapidly approaches amid a surge in pediatric Covid hospitalizations. Parents desperately want to know: When can young children get the Covid vaccine?
This week, those parents got significantly closer to an answer. On Monday, the U.S. Food and Drug Administration fully approved Pfizer and BioNTech's Covid-19 vaccine for people 16 years of age and older. The move doesn't particularly affect children ages 12 to 15, who have been vaccine-eligible under an emergency use authorization since May, but it could have major implications for children in the 5-to-11 age bracket.
Legally, full approval opens the door for doctors to administer the Pfizer vaccine for "off-label" use, where approved drugs or vaccines are prescribed for unapproved uses. Generally speaking, the tactic is common — medications are often prescribed for off-label uses, particularly for children — and could theoretically be used now to vaccinate young kids against Covid-19. The daily nationwide average of new pediatric hospitalization admissions rose to 309 for the week ending Aug. 23, according to data from the Centers for Disease Control and Prevention, the highest number on record since the agency started tracking pediatric Covid cases last year.
Yet medical organizations and experts still strongly recommend that eager parents and their children wait. The American Academy of Pediatrics released a statement on Monday discouraging clinicians to give the vaccines off-label to kids under 12, citing a lack of sufficient data about the suitable dosage for the age group. The FDA also said this approach is "not appropriate."
If you're clamoring to get an off-label vaccine for your child under age 12, here's why it's worth it to hold off and when you can expect kids to be eligible for Covid vaccines:
Medications for adults are frequently prescribed off-label at lower doses for children, says Dr. Carl Fichtenbaum, a professor of infectious diseases at the University of Cincinnati and UC Health. Vaccines, however, are a "different animal."
The reason: A child's immune system responds completely differently to vaccinations than an adult's immune system. As you grow, your body develops a greater ability to respond its environment — a process that doesn't fully take hold, at least when it comes to vaccinations, until shortly after puberty. "Children are not small adults," Fichtenbaum says.
That means the crucial question isn't whether or not a child should get vaccinated. Rather, it's determining the right dose size, says Dr. Pedro Piedra, professor of molecular virology and microbiology and of pediatrics at Baylor College of Medicine in Houston.
Typically, vaccine dosage is based on factors like weight, age and how that particular vaccine moves throughout the body. If a dose is too low, it risks being ineffective. If it's too high, Piedra says, the injection could cause particularly severe fevers and headaches as short-term side effects.
An adult dose of the vaccine could also increase a child's chances of developing myocarditis, a rare side effect of the mRNA vaccines that causes inflammation of the heart and tends to be more common in young people. In late July, the FDA asked Pfizer and Moderna to enroll more children in clinical trials to look for myocarditis. In severe cases, myocarditis can cause permanent damage of the heart muscle, potentially leading to heart failure, heart attack or stroke and irregular heart rhythms.
Fichtenbaum also says kids are more likely to have unforeseen reactions to vaccines. "Children are always different," he says. "And no one can ever tell."
At the same time, Fichtenbaum notes, he understands parents' concerns. "It is really frustrating and hard to watch the grass grow," he says. "So one gets very impatient."
Clinical trials for the 5-to-11 age group are currently in progress , which means those children will likely become vaccine-eligible around late fall or early winter, White House chief medical advisor Dr. Anthony Fauci told NBC's "TODAY" on Tuesday. There will be a separate evaluation for children ages 2 to 5, with babies six months to 2 years old in the final group.
Some parents will almost certainly seek out vaccines for their kids before they're officially vaccine-eligible, says Dr. Leana Wen, an emergency physician and public health professor at George Washington University. The FDA clearly discourages this practice, she says, and doctors should follow those federal recommendations.
"I cannot imagine that there would be many pediatricians out there clamoring to take that risk," Fichtenbaum adds. "Vaccinating someone with an unknown dose and unknown side effect profile."
The clearest sign that it's safe for parents to get vaccines for their children will be when the vaccines are authorized for emergency use for ages 5 to 11 by the FDA, Piedra says. Emergency use authorization means the federal agency has rigorously reviewed the data and determined the optimal dosage for the age group. "Do your best to try to wait for the science to catch up with everything," advises Fichtenbaum.
In the meantime, Wen says, the FDA could be more transparent with the public about where they are in the authorization process for younger age groups. Once Pfizer and Moderna have enough data to submit to the FDA, the agency will "move swiftly" to evaluate it, Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said in a video news conference Monday.
Pfizer expects to submit data by the end of September to apply for emergency use authorization. Moderna is aiming for late fall and early winter. Johnson & Johnson plans to start a trial in children as young as 12 this fall.