Since the COVID-19 pandemic began over one year ago, the race for safe and effective vaccines has been front and center in medical research. Trials began with older adults as study participants, while clinical vaccine studies have now been extended to children 12 to 17 years of age.
Moderna’s clinical studies involving children from 12 to 17 years old reached Phase 3 studies in December 2020, with results being expected during the summer of 2021. Experts are hopeful results will facilitate a safer and smoother transition back to on-site learning in the classroom for students in this age group during the fall.
Moderna’s KidCOVE Study
Recent studies have been expanded to include healthy children in the 6-month to 11-year-old age range. These studies are in the early stages and will likely extend through 2021, so widespread vaccination of children under age 12 will probably not occur until 2022.
The KidCOVE clinical study is designed to test the effectiveness and safety of the vaccine known as mRNA-1273. Children receiving the vaccine will be compared with a control group receiving a salt-water solution that looks identical to the active vaccine but has no protective power against the coronavirus.
The 14-month study will enroll 6,750 participants aged 6 months to 11 years who are in good health. They are exempt, however, if they meet any of the following:
- If you have been in contact with anyone infected with COVID-19 within two weeks of receiving the vaccine
- If you have tested positive for COVID-19
- If you have taken any approved or investigational treatments for COVID-19
- If you have been a participant in a COVID-19 trial within the past month
What Participants Should Expect
- Two shots will be administered 28 days apart
- Dosages will be 25, 50, or 100 micrograms
- The first part of the study will determine the second dosage
- Regular telemedicine check-ins to log daily symptoms in a smartphone app
- Parents and child may return for up to 6 visits to the study site for review
Benefits of Participating in a Clinical COVID-19 Study
Over 3.2 million children have become infected with COVID-19 in the United States, with as many as 266 deaths being recorded. Knowledge is power. Information collected in the study will bring us closer to the end of the terrible pandemic, help establish herd immunity, and restore the world to as we knew it before the virus.