Pharmaceutical giant Moderna has initiated a clinical trial to evaluate its COVID-19 vaccine in children under the age of 12, including infants as young as six months. This significant study aims to enroll 6,750 healthy children across the United States and Canada.
“There’s a significant interest in understanding how vaccinations might work for children,” stated Dr. Alex Rivera, medical director of the pediatric vaccine program at the University of California, in an interview with the New York Times.
Participants in the trial will receive two doses of the vaccine, spaced 28 days apart. For children aged two to twelve, the doses will vary between 50 and 100 micrograms, while those under two could receive doses of 25, 50, or 100 micrograms. This study is particularly welcomed by parents eager to protect their children as many adults are already getting vaccinated. Dr. Anthony Fauci and other public health experts have emphasized the importance of vaccinating children to achieve herd immunity, and the American Academy of Pediatrics has advocated for extending vaccine trials to include younger age groups.
In a concurrent study, Moderna is also testing its vaccine on 3,000 adolescents aged 12 to 17, with results anticipated this summer. If the data confirms the vaccine’s safety and efficacy for this age group, it will require authorization before becoming available for distribution. Currently, the Pfizer-BioNTech vaccine has received FDA approval for individuals aged 16 and older, while Moderna is limited to those 18 and older.
In Moderna’s studies, the first participants will receive the lowest vaccine doses, with close monitoring for any reactions before higher doses are administered. Researchers will assess the safest dosage for each age bracket, and the subsequent phase will involve administering doses based on these findings, or placebos. Following vaccination, children will be observed for a year to monitor for side effects and measure antibody levels to gauge vaccine effectiveness.
Predictions for when children might receive vaccines vary, with older children potentially eligible as soon as this fall. However, younger children may have to wait until late 2021 or early 2022. This trial marks a crucial step in the ongoing effort to understand and combat COVID-19, occurring one year after the initial adult trials began.
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Summary:
Moderna has commenced a clinical trial to evaluate its COVID-19 vaccine in children as young as six months, enrolling 6,750 healthy kids in the U.S. and Canada. Parents are eager for their children to gain vaccination protection, especially as adults are already being vaccinated. The study includes various dosage levels and aims to find the safest option for each age group. Results from related trials for adolescents are expected soon, with timelines for younger children’s vaccinations projected for late 2021 or early 2022.