Pennington Biomedical Research Center is conducting its first vaccination trial, evaluating the safety and effectiveness of Moderna’s COVID-19 vaccine for children under 12 in a Phase Three clinical trial.
“This is crucial and potentially life-saving research,” said Daniel Hsia, MD, associate professor, Clinical Trials Unit, and site principal investigator of the study. “In the past two months, we’ve seen a substantial increase in the number of children testing positive for COVID-19. Unlike earlier variants of the virus, the Delta variant is taking a considerable toll on kids, most of whom haven’t been vaccinated.”
The U.S. Food and Drug Administration has not yet authorized any COVID-19 vaccines for use in children under 12, Hsia said. However, clinical trials like this one provide important data on the safety and effectiveness of the vaccine in thousands of children.
Amy Thomassie, research nurse and lead study coordinator, said part two of the study involves three different age cohorts with 75 percent of the children receiving the vaccine and 25 percent receiving the placebo. Pennington Biomedical has already filled all of its slots in the six to 11-year-old cohort.
The next cohort will enroll children from two to five years of age, and this part of the study is projected to start around the end of September.
The last cohort will enroll children from six months to less than two years of age, and this portion of the study is projected to start in October or November.
The Food and Drug Administration will review the results of part two as part of the approval process for the vaccine’s use in children, Hsia said.
Pennington Biomedical’s selection as a participating site in this vaccine trial is an important milestone for the Research Center and is an example of how the Center can pivot to address the important health problems facing our world today, Executive Director John Kirwan, MD, said. It also marks a new chapter for the Clinical Trials Unit, which helped test many of the prescription medications used to treat diabetes and all of the prescription medications used for weight loss.
Kirwan said the evaluation of a safe and effective vaccine for children is urgently needed.
“We don’t know what, if any, long-term effects COVID-19 will have on our children’s health,” Kirwan said. “But we do know that vaccines can help decrease your chances of getting and spreading the virus and help prevent serious illness even if you get the virus.”
The Moderna COVID-19 vaccine is a messenger RNA (mRNA) vaccine. The vaccine doesn’t contain the virus. It’s more like a text message that tells your immune system what the virus looks like and how to defend against it. Once the instructions have been delivered, the message deletes itself.
Moderna’s KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
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