Several coronavirus vaccines awaiting FDA approval have shown high levels of effectiveness in adults, but the results from phase three clinical trials haven’t included children, and a group of physicians is hoping to change that.
The lack of testing on children has led to concerns about how quickly vaccines can be rolled out and administered to the general public.
“We do not have any data right now about vaccine safety or efficacy in children,” Dr. Ronda Oram, an infectious disease physician at Advocate Children’s Hospital, said.
In October, Pfizer became the first and only major pharmaceutical company to include children in its clinical trials of a coronavirus vaccine, but only allowed older children to participate in the trial.
“They just started looking at children 12 years of age or older,” Dr. Alison Tothy, a pediatric emergency medicine specialist at the University of Chicago, said. “They haven’t looked at children below that age, so that is still an unknown.”
Tothy and other pediatric specialists say that drugmakers need to step up their efforts to evaluate the impact the vaccine has on children, saying that doing so is a critical step to getting kids back into classrooms and onto athletic fields.
“They need to get back to school. They need to get back to their sports,” Tothy said. “Those things require having the vaccine to really ensure that we can do those things safely.”
The American Academy of Pediatrics is calling on researchers to expand clinical trials to children of all ages as soon as possible.
“We absolutely need safety data and we need efficacy data,” Oram said. “That dose might be different, or it could be administered in a series of vaccines, rather than just two doses (like adults will require).”
Ultimately, drugmakers would need a separate authorization from the FDA before children would be allowed to get a COVID-19 vaccine.
“The hope is that there's more research done soon on children of all ages, because we hope that kids can get the vaccine like adults can,” Tothy said.