An FDA Committee of independent vaccine experts today endorsed Moderna’s two-dose Covid-19 vaccine for children, a vital hurdle on its path to being given to children.
It was approved unanimously for use in children from Kindergarten to high school, after weighing the safety of the shot in the public meeting.
According to the FDA, no cases of myocarditis were found in children during Moderna’s clinical trials of the vaccine, however other adverse effects seen included pain at the injection site, fatigue, headache, chills, muscle pain and nausea.
The one caveat was the clinical trials preceded the rise of the Omicron variant, and as a result the degree of protection afforded by the shots was acknowledged to be unclear. In other age groups a third shot was shown to increase efficacy against Omicron. Moderna intends to provide data on that, in these age groups, soon to the committee.
In other variants which preceded Omicron, the vaccine was found to be 90% effective on 12 to 17 year olds confronted with the alpha variant, and the original strain detected in Wuhan, China. The shot was 76% effective in children 6 to 11 when faced with the Delta variant.
It is expected children 6 to 11 will receive a smaller 50 microgram dose, while children 12 to 17 would receive a normal 100 mg adult dose.
Moderna had sought approval for its vaccine among 12 to 17 year-olds more than a year ago. However at the time it was noted international data showed a slightly higher risk of Myocarditis with Moderna’s vaccine than Pfizer’s shot.
Subsequent US vaccine surveillance concluded that the rates of myocarditis from Moderna’s vaccine were similar to those of Pfizer, and the application was allowed to continue forward.
Dr. Mark Sawyer, a professor of pediatrics at the University of California San Diego and temporary voting member said, “I am a little bit sobered by the myocarditis data and the frequency with which that is occurring. So that clearly needs to be watched closely going forward as we expand the use of the vaccine.”
Committee member Dr. Paul Offit, said two doses would likely not protect against mildness illness from omicron, but it would likely curtail severe illnesses, if given with a third dose.
Offit, a pediatrician and infectious disease expert at Children’s Hospital of Philadelphia said, “I think the benefits clearly outweigh the risks, but I say that with the comfort being provided that there will be a third dose. If that was not true, I wouldn’t feel the same way. We’re not in the same part of this pandemic anymore. It’s a different time.”
The FDA is expected to complete the authorization process this week, at which point the CDC will then have to approve the shots before they will begin being administered to children. However with this major hurdle overcome, it is possible Moderna vaccinations of children could begin as soon as next week.
Pfizer and BioNTech’s vaccines are already approved for children five and up. However as the pandemic passes, and with the current variants having mild reputations, only about 30% of children aged 5 to 11, and 60% aged 12 to 17 are fully vaccinated as of early June.
There will be another FDA committee meeting on Wednesday, to discuss the vaccine for infants through preschoolers, which are the only children left who are not eligible for vaccination.
The FDA is expected to authorize the vaccines this week.
