MUSC poised to enroll hundreds of children in COVID-19 vaccine clinical trial this year – Charleston Post Courier

There's been a lot of talk about "herd immunity" these past several months what it is and how we get there. If it's even possible to get there.

The idea of it involves inoculating a critical mass of people somewhere close to 80 percent of the population so that the spread of disease is significantly hindered.

Right now, we're nowhere close to that magic number. As of April 19, the Centers for Disease Control and Prevention reported just more than 25 percent of the U.S. population had been fully vaccinated against COVID-19. And even accounting for the percentage of people who developed some level of immunity to the disease after surviving the virus, this country won't be reaching herd immunity anytime soon, if ever.

But vaccinating children will get us closer.

Dr. Andy Atz,chairman of the Department of Pediatrics at the Medical University of South Carolina, estimated that 20 percent to 25 percent of the entire population is under the age of 18. If achieving herd immunity requires at least 80 percent of the population to develop immunity, that target will remain unattainable until at least some children become eligible for the vaccine.

As it stands now, though, the federal government hasn't approved a COVID-19 vaccine for use among most children. The only children currently eligible for a vaccine are those who are at least 16 years old, and even then, those teenagers are only permitted to receive the Pfizer-BioNTech vaccine. While the government will likely approve both the Moderna and Pfizer shots for children older than 12 soon, it could take several more months before the Food and Drug Administration makes more of these vaccines widely available to the youngest patients through an emergency use authorization.

In the meantime, enrolling children into a clinical trial for a COVID-19 vaccine will allow many families to bypass that long wait.

Already, hundreds of parents have expressed an interest in signing their children up for one of these trials at MUSC, Atz said.

"The demand is huge," he said.

In the Lowcountry, Coastal Pediatric Associates was one of few sites in the country selected to study the effects of the Moderna vaccine among 12- to 17-year-old patients. Moving forward, that research will encompass younger patients, too, and Atz said he anticipates MUSC will start enrolling children in a trial for the Moderna vaccine soon.

Three different age cohorts will be studied: 6- to 12-month-olds; 2- to 6-year-olds; and 6- to 12-year-olds, and several different doses will be tested within each age group. Enrollment will start slowly and eventually ramp up later this summer and fall, Atz said.

The research really boils down to determining the correct dose of the vaccine to give these different age groups, he said. The vaccines have already been administered to tens of millions of adults, and they're very likely very safe for children, he said. But kids are considered a vulnerable population, and determining the precise amount of vaccine they should receive, based on their age, is an important part of the process.

"We know theres a huge difference between a 6-month-old and an 11-year-old, and thats why wed expect the dose to be different," he said.

The process is moving more slowly than many families would like, though there are medical ethics to consider.

The MUSC Shawn Jenkins Childrens Hospital has been selected to participate in a clinical trial that will allow some children to receive the Moderna COVID-19 vaccine. File/Andrew J. Whitaker/Staff

In a March article published by Pediatrics, the medical journal of the American Academy of Pediatrics, experts explained that children need to be handled with care when it comes to clinical research, primarily because they can't provide legal consent.

"As a result, minors are less able to protect themselves from being exposed to excessive research risks," the authors wrote. "A common way to satisfy these requirements is to enroll minors only after there is evidence of safety and efficacy in adults. Yet, waiting until safety and efficacy have been established in adults could substantially delay an effective pandemic response."

Atz said the process of enrolling children in the next phase of the trial will be "very regimented." It will start slow, with small numbers of children in each age group. Researchers will observe these patients closely to determine what is likely the safest and best dose, and when that is accomplished, the trial will scale up in a rapid way, probably sometime around August.

That means more waiting. But in the meantime, Atz advised, there is something very effective that parents can do to protect children from COVID-19: "They can get vaccinated themselves."

Reach Lauren Sausser at 843-937-5598.

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MUSC poised to enroll hundreds of children in COVID-19 vaccine clinical trial this year - Charleston Post Courier