The COVID vaccines are rolling out quickly, in fact, according to the CDC over 20 million people have received at least one dose of the vaccine. However, these numbers do not include children, and many beginning to wonder when will children be able to get vaccinated and when? The answers to those questions require children to participate in Covid clinical trials. Here’s what you should know.
If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.
The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people ages 16 and up. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.
It will take months to approve use of the vaccines for middle- and high school-aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.
Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says Dr. James Campbell, professor of pediatrics at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health. Campbell and colleagues say it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.
Much of the debate centers on two issues: the degree of harm COVID-19 causes children and the extent to which children are spreading the virus to their friends, teachers, parents, and grandparents.
COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among people 19 and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.
Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Dr. Stanley Plotkin, professor emeritus of pediatrics at the University of Pennsylvania, told a federal panel. That’s in line with the percentage who become gravely ill as a result of infections like Haemophilus influenza type B, or Hib, for which doctors have vaccinated children since the 1980s, he pointed out.
Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, points out that “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”
The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.
“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Dr. Yvonne Maldonado, a professor of pediatrics at Stanford University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”
Other pediatricians worry that early pediatric trials could backfire. Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes Multisystem Inflammatory Syndrome in Children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.