Peter Hotez, MD, PhD, FASTMH, professor of pediatrics and molecular virology and dean, National School of Tropical Medicine, Baylor College of Medicine, and codirector, Texas Children’s Hospital Center for Vaccine Development, addresses the approval of the Pfizer/BioNTech COVID-19 vaccine for children aged 5 to 11 and emphasized its benefits far outweigh the rare possibility of myocarditis.
Unvaccinated children have been swept up in the Delta variant firestorm, which has increased the urgency for this vaccine for the 5 to 11 age group, noted Peter Hotez, MD, PhD, FASTMH, professor of pediatrics and molecular virology and dean, National School of Tropical Medicine, Baylor College of Medicine, and codirector, Texas Children’s Hospital Center for Vaccine Development.
What must parents and providers consider with the FDA’s EUA of the Pfizer/BioNTech COVID-19 vaccine for children?
I would have liked to have seen more of a full-throated endorsement of the vaccine. The vote was unanimous except for 1 abstention. But the need for a vaccine for children ages 5 to 11 is clear. We've had more than 8300 hospitalizations, with this big 5- to 10-fold increase in the number of hospitalizations over the summer because of the Delta variant, because it's so highly transmissible. It's not so much that it's selectively infecting kids, just that it's so highly transmissible that unvaccinated kids are getting swept up in that Delta variant firestorm. We've had at least 100 children die between the ages of 5 to 11. Overall, 700 children have died in this epidemic. And most of the hospitalizations and pediatric intensive care unit admissions that happened over the summer were from the Delta variant. So we're going in the wrong direction with respect to child health because of COVID-19. Hence, the urgency for this vaccine.
I think the concerns that everyone raises is the fact that we have seen 1 safety signal in young adults, in their 20s, and in some teenagers, and this is of course myocarditis, which has been noted more commonly after the second dose of the mRNA vaccine. The good news is it’s extremely uncommon. We're looking at roughly about 1 in 10,000 individuals who have gotten the mRNA vaccines have had this problem. It's usually quite manageable, although it may require hospitalization—so it's rare.
I think the one concern that was raised is the fact that the clinical trial leading to the emergency use authorization [EUA] in 5- to 11-year-olds was done in 2200 kids—roughly 1500 who got the vaccine and 700-plus got the placebo—and that would not be sufficient to see 1 in 10,000 events. I think that was perhaps the only reservation.
But overwhelmingly, the risk of severe COVID-19 leading to hospitalization far outweighs that potential possibility of myocarditis in the younger kids.