America's Doctors Say COVID-19 Vaccine Trials Must Start Including Kids—Now

The American Academy of Pediatrics (AAP) is sounding the alarm on the consequences of not immediately including children in ongoing COVID-19 vaccine research.

Preliminary data released from drug manufacturers Moderna and Pfizer Inc. this month has been extremely impressive, suggesting both vaccines may be more than 90% effective.

But as members of the AAP argued earlier this fall — and reiterated in an open letter to federal health officials on Tuesday — it is essential that the Food and Drug Administration stick to “transparent requirements” for measuring risks and benefits of vaccines in all sub-groups of the population, including children.

The letter was also signed by six other major medical groups, including the American College of Obstetricians and Gynecologists (ACOG) and American Medical Association (AMA).

“We eagerly anticipate seeing the safety and efficacy data in vaccine trials that are underway in adults, and urge pharmaceutical companies to rapidly expand their participant panels to include children and adolescents,” Dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, said in a press statement.

Buoyed by the preliminary findings from Pfizer and Moderna, experts have predicted it’s possible that multiple coronavirus vaccines could be widely available in the U.S. by next spring. But thus far children have been largely excluded from the vaccine research.

In late October, Pfizer was given the green light to test its vaccine in children in the U.S. ages 12 and up. And Moderna has indicated it plans to start testing its vaccine in children, pending approval to do so.

All of which means that children may not have a vaccine available to them until well into 2021.

“This research takes time. If this does not begin soon, it will be less likely a vaccine will be available for children before the next school year,” Maldonado said.

Of course, one significant challenge is that parents must volunteer their kids to receive an experimental treatment. Some parents who have enrolled their children in Pfizer’s study say they have faced trolling online from people questioning their judgment.

But pediatricians cite many reasons why it is essential to test COVID-19 vaccines in children. For one, their immune systems are different than adults’, and they also appear to respond differently to COVID-19 itself for reasons that are not fully understood.

Children also face the rare but serious risk of multisystem inflammatory syndrome in children, or MIS-C, which appears to develop weeks after they are exposed to the coronavirus. It’s important that whatever vaccine is available to children not trigger a similar response.

Delays in vaccinating children could also hamper our collective effort to stem COVID-19 transmission. As Dr Priya Soni, a pediatric infectious disease specialist at Los Angeles’ Cedars-Sinai Medical Center, told HuffPost in October: “Children could likely remain a large reservoir for infection. This would in turn undermine all our other pandemic mitigation efforts.”

Experts also say children must be included in trials as soon as possible to shore up public trust in vaccines when they become available. Vaccine hesitancy among parents is an ongoing public health problem in the U.S., and the AAP fears that it will only be exacerbated by not including children in ongoing vaccine research as soon as possible.

“Assuming that one or more of these vaccines are shown to be safe and effective in adults, in order for parents to be comfortable giving these vaccines to their children, we must have studies showing they are safe and effective in children as well,” Maldonado said.