CHARLOTTE, N.C. (WBTV) - While the COVID-19 vaccine has been focused on adults and teenagers, younger children are now being considered.
Moderna Inc. announced Tuesday that the first participants have been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the Company’s vaccine candidate against COVID-19, in children ages 6 months to less than 12 years.
The company says it plans to enroll 6,750 pediatric participants in both the U.S. and Canada.
Charlotte pediatrician Dr. Laura Sinai said it’s important children are considered in these studies and for the vaccine because they are also at risk of getting the virus.
“Even though it seems like the most affected or the most seriously affected people are the adults and older adults, children are not left out of this mix,” Dr. Sinai said.
Dr. Sinai said children can also be high-risk like adults; this can include a variety of conditions like diabetes, immune deficiencies, and more.
Rochelle Wilensky’s four-year-old daughter Keren is at high risk. She said for the past year they have been strictly quarantining, and her daughter no longer attends preschool in person. For them, getting Keren the vaccine is critical.
“She has a rare genetic autoinflammatory disease and the effects if she got COVID could be catastrophic,” Wilensky said.
Wilensky and her husband both got vaccinated as caregivers for medically complex children.
She said she wouldn’t hesitate to drive across the country if her daughter could participate in the study and get the vaccine sooner.
Dr. Sinai said having kids participate in the study could also help children with other conditions including Multisystem Inflammatory Syndrome in Children or MIS-C.
“There have been over 2,500 cases in the United States this year with quite a few deaths so it’s a very serious disease so it would be wonderful to eliminate that or at least reduce that,” Dr. Sinai said.
Wilensky did not share the name of her daughter’s disease but clarified it is not MIS-C; however, because of her current disease she is also at higher risk of getting MIS-C.
Dr. Sinai said getting children vaccinated will also help with reaching herd immunity, and it would be helpful for kids to get vaccinated as the push for in-person learning grows.
“In addition to vaccinating adults, teachers, and so forth, vaccinating the children is going to make this school process much more successful,” Dr. Sinai said.
Dr. Sinai said each age group may require a different dosage because age groups react differently.
Moderna Inc. said children will be monitored for a year following their second vaccination.
Wilensky said it’s been a long year quarantining and taking extra precautions, her hope is that the vaccine for children gets approved not just for her child but others too, so kids can safely be kids again.
“To be able to see that light at the end of the tunnel is and some hope that we’re going to be okay they’re going to be would just be incredible,” Wilensky said.
Wilensky is optimistic that the vaccine for children will get approved and hopes to get her daughter vaccinated by her fifth birthday in October.
Moderna Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the first participants have been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the Company’s vaccine candidate against COVID-19, in children ages 6 months to less than 12 years. The 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.
This Phase 2/3 two-part, open-label, dose-escalation, age de-escalation (Part 1) and randomized, observer-blind, placebo-controlled expansion study (Part 2) will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. The Company intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada ages 6 months to less than 12 years.
In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 μg or 100 μg). Also in Part 1, each participant ages six months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg).
An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination. Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population. Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study. The ClinicalTrials.gov identifier is NCT04796896. For more information about the trial, including the process for enrolling participants, please visit www.kidcovestudy.com.