The University of Wisconsin School of Medicine and Public Health has begun testing the COVID vaccination on infants and toddlers aged six months to five years. They will be one of several vaccine sites across North America testing the Moderna vaccine, which has not yet been approved by the Food and Drug Administration. The testing will be conducted on around 4,000 very young children, a portion of which will be performed at the University of Wisconsin’s testing site.
The University of Wisconsin is one of 75 to 100 clinical test trials across the United States and Canada. Within the clinical trial for the infants and toddlers aged six months to five years, the Moderna vaccine will be administered in two doses, which will be given four weeks apart. The study of the results will last 14 months and each participant will attend four follow-up appointments after receiving the doses.
The clinical trial for the infants and toddlers is a placebo-controlled trial, which means that those within the study will receive either the Moderna COVID vaccine or the placebo and they will be unaware of which they are given.
Bill Hartman, MD, PhD, who is the co-principal investigator of the KidCOVE clinical trial at the University of Wisconsin – Madison, called the trial “the final frontier.” Hartman said, “This is the final frontier. Our very youngest children need to get the vaccine and we need to make sure they are safe. The kids participating are heroes. They will be able to tell the story of how they helped save the world.”
The vaccine trial will also have clinical trial diversity. According to a press release from the University of Wisconsin, “Approximately 80% of the participants in the trial in Madison are from underserved populations meaning they might face barriers based on race, ethnicity, income, geography and health outcomes, according to study leaders.”
Emily Kumlien, the press secretary for the University of Wisconsin Health Communications, told The Wisconsin Daily Star that they do not have the data regarding the number of infants and toddlers who have contracted COVID or the severity of those cases. Kumlien referred The Daily Star to the Wisconsin Department of Health for that information as they have tracked that data.
When asked why the University of Wisconsin chose to conduct a clinical trial of the Moderna vaccine, Kumlien explained that the reason was just because of “logistics.” She said that they “have nothing against” the Pfizer/BioNTech vaccine, which is the COVID vaccine that has been granted emergency use authorization for children aged 5 to 11 by the Centers for Disease Control (CDC).
According to the Wisconsin COVID dashboard, at this point, no infants or children between the ages of 0 and 9 years old have died from COVID in Wisconsin. The data from the Wisconsin COVID dashboard indicates that 14,510 infants and toddlers aged 0 to 3 have contracted COVID as of November 8, or about 18% of Wisconsin infants and toddlers aged 0 to 3.
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