UNM to do clinical trial for children’s virus vaccine
Researchers to evaluate efficacy, safety for kids 6 months to 12 years
Because “kids are not just little adults,” information about the efficacy and safety of a COVID-19 vaccine on adults can not be extrapolated and applied to children, Dr. Walter Dehority, a pediatric infectious disease expert at the University of New Mexico School of Medicine, said Monday.
“Children have developing immune systems that are not as experienced as adults, and they haven’t lived as long and haven’t seen, for example, the influenza virus over and over again,” he said.
To determine exactly how a child might respond, researchers at the UNM Health Sciences Center have been approved to participate in a clinical trial to evaluate the efficacy and safety of the Moderna COVID vaccine on children age 6 months to 12 years, Dehority said. The trial will involve 6,750 children nationwide who will be followed for one year after their second shot in the two-shot vaccine process.
The clinical trial is expected to begin locally no later than early summer, he said. It is being sponsored by Moderna, in conjunction with the National Institute of Allergy and Infectious Disease, which is led by Dr. Anthony Fauci, and is part of the National Institutes of Health.
Anticipating that parents may have questions about the ethics of testing a vaccine on children, Dehority said that not testing the vaccine on children leaves two unethical options: “One is, you never vaccinate kids, which is a problem because then they don’t have access to the vaccine that adults do; or two, you decide to vaccinate kids with an untested vaccine that
you have no idea how safe it is or if it works.”
From a public health point of view, the best recourse is to test the vaccine on children, “but do so in a controlled, safe environment where there are physicians on call,” he said.
In testing on adults, the Moderna vaccine has been shown to be 95% effective against contracting the virus, and 100% effective preventing the most severe symptoms of the disease. By comparison, “a flu shot may only be 60% effective in a given year,” Dehority said.
The Moderna vaccine is particularly safe because it uses new messenger RNA (ribonucleic acid) technology, he said.
That technology involves using a little piece of the RNA genetic blueprint of the virus, “but not the live virus itself,” as a way to elicit an antigen-antibody response.
“There are no structural parts of the virus being injected, just the genetic blueprint for a tiny part of it. The messenger RNA then dissolves and disappears, but not before the human immune system reads it and starts manufacturing antibodies against it,” Dehority explained.
While the Pfizer COVID vaccine also uses messenger RNA technology and is about as effective and safe on adults as the Moderna vaccine, the test results from this clinical trial on children will only apply to the Moderna vaccine. Pfizer and the other pharmaceutical companies producing a COVID vaccine are, or will have to, conduct their own trials on children under FDA scrutiny, Dehority said.
To recruit study participants, Dehority and his collaborators will reach out to pediatricians, as well as the community through the UNM Clinical and Translational Science Center.