Kids under 12 participate in vaccine trials as Pfizer efforts FDA emergency authorization

The American Academy of Pediatrics found that nearly 29% of reported COVID-19 cases last week were amongst children, nearly twice as high as the rate over the course of the pandemic. It comes in the midst of a surge of cases spurred by the more transmissible Delta variant, which has largely impacted people who are not vaccinated.

While vaccines have been available to most of the general public for several months, that is not the case for children younger than 12 years old. Pfizer anticipates sharing their vaccine data for children ages 5 to 11 over the next couple weeks, and hopes to do the same for children between six months and four years old a month later. Part of company's research is being conducted in the Triangle; Dr. Richard Chung's two sons are part of different trials.

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"I had a lot of different information to consider. Certainly we had to be really thoughtful about that. But the opportunity to really push forward this research so that kids, not just Joshua and Caleb, but kids more broadly, had the opportunity get protected. That was a really strong impetus for us to participate," said Dr. Chung, a pediatrician who is the Director of Adolescent Medicine at Duke.

His elder son, Caleb, is 13 years old and received the vaccine during the trial. His younger son, Joshua, is 8 years old, and they are not yet sure if he received the vaccine or a placebo.

"(Joshua's) participation was really related to generally wanting to help out and push back against the pandemic. Certainly at that younger age it's a little bit harder for him to understand all of the different nuances so we had to kind of talk through what exactly research is, and what it looks like to participate in a very concrete specific way, and what he would need to do as part of it. But he was very eager to participate, and as parents we were very supportive," said Dr. Chung.

From a professional standpoint, Chung relayed that he often hears questions from parents about the COVID-19 vaccine.

"It does come up often, 'what would you do in this scenario?' And being able to share that we took the step of actually enrolling our kids into the vaccine trial can be meaningful to many folks," said Dr. Chung.

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Dr. Chung is not the lone Duke doctor whose children are participating in the trial. Dr. Susanna Naggie's twin nine-year-old girls became the first in the country to participate in the Phase 1 of the Pfizer and BioNTech Clinical Study Trial in children younger than 12. Dr. Naggie is the Vice Dean for Clinical Research at Duke University's School of Medicine.

"I think it's really telling actually that a lot of healthcare professionals are the ones who are volunteering their kids to participate and to advance these studies, because both we kind of see the burden that is COVID-19 full-fledged every single day in the hospital. But we also have that high confidence in the scientific process and the belief that vaccines are really safe and effective," Dr. Chung noted.

In North Carolina, 14% of the population is 11 years and younger.

Moderna is also conducting research for vaccines in children younger than 12 years old, though their data is not expected to be ready for FDA review until after Pfizer's submission.
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