Doctors: No ‘off-label’ vaccines for children
Leading pediatricians said loudly and in unison Monday that doctors should not prescribe COVID-19 vaccines to children under 12.
With the Food and Drug Administration’s full approval of Pfizer-biontech’s vaccine, such “off-label” use is now legal. But it’s definitely not a good idea, a number of experts said.
“We don’t have the data on young children. So that really ought to be a nono,” said Dr. Jesse Goodman, an infectious disease expert at Georgetown University. “The science is not there to support dosing yet in small children.”
Children under 12 have not yet been approved to receive any COVID-19 vaccine, for the simple reason that it has not yet been proven safe and effective for them. Plus, while everyone 12 and up is given the same dose, a child of 5 years probably would need a smaller amount of vaccine than someone age 55, Goodman and others said.
Studies in children 5 to 11 are likely to be finished early this fall, Pfizer and its German partner Biontech have said, and trials in younger children probably will not be ready until the end of the year or early next year.
“We need to see the data from those studies before we give this vaccine to younger children,” Dr. Lee Savio Beers, president of the American Academy of Pediatrics, said in a prepared statement. “The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”
The pediatricians association “strongly recommends” that adolescents 12 and up, who are already eligible for the vaccine, be vaccinated. “The data from clinical trials and experience with the vaccine over the past four months in these adolescents show that it is safe and very effective in this age group,” Beers said.
Children younger than 12 should wear masks while in school and in public settings, as well as avoid crowds and wash hands regularly, public health officials have said.
“While we wait for vaccines, we have measures that are effective,” Dr. Bob Frenck, lead researcher for Pfizer’s vaccine studies and director of Vaccine Research Center at Cincinnati Children’s Hospital Medical Center, said via email.