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Clinical Trials for Kids
The COVID-19 vaccine will be instrumental in ending the coronavirus pandemic, but Moderna, one of the manufacturers with a vaccine currently in clinical trials, needs adolescent volunteers. Without enough 12- to 17-year-olds signing up for the vaccine trial, FDA approval for people under 18 could be significantly delayed.
While the virus has more heavily impacted adults, to defeat the pandemic, children will also have to be immunized, which means trials are necessary to make sure vaccines are safe for them. At least 3,000 adolescent and teen participants are required to complete Moderna’s COVID-19 trial.
Kelsey-Seybold’s
Chief of Pediatrics Jessica Lanerie, M.D., answers commonly asked questions about involving kids in COVID-19 vaccine clinical trials.
Why is it important for adolescents and teens to take part in Moderna and other vaccine trials?
Dr. Lanerie: The Moderna vaccine was authorized by the FDA in December for people 18 and over, but anyone under 18 may need a different dosage or different vaccine schedule – which is why this adolescent and teen trial is necessary.
Why is it important for adolescents and teens to take part in Moderna and other vaccine trials?
Dr. Lanerie: The Moderna vaccine was authorized by the FDA in December for people 18 and over, but anyone under 18 may need a different dosage or different vaccine schedule – which is why this adolescent and teen trial is necessary.
It’s been reported children generally have a milder reaction to COVID-19 infection, so why should they be vaccinated?
Dr. Lanerie: COVID-19 typically leads to a milder illness in children and adolescents when compared to adults, but severe and fatal illness is possible. As of Jan. 7, 2021, around 2.3 million children in the U.S.A. have tested positive for COVID-19, and anyone who has the virus can spread it to others.
There is growing concern that even a mild initial COVID-19 infection could lead to long-term complications in both adults and children. Most importantly, without children and adolescents getting vaccinated, herd immunity may not be possible.
Why not just give adolescents and teens the same vaccine as adults?
Dr. Lanerie: It’s essential to collect data on the efficacy of the vaccine in children and adolescents. As with all vaccine clinical trials, determining side effects is an important part of the study as well. Because of the lack of study data, it’s currently impossible to say when the vaccine will be available to children.
Should I enroll my child or teen in the Moderna COVID-19 vaccine trial?
Dr. Lanerie: This is a decision for parents or guardians to make, but it’s worth considering, as a vaccine for children could mean protecting them from a potentially severe illness and a return to normalcy. As with most medical decisions, children under 18 need parental consent to sign up for vaccine clinical trials. Before deciding whether to enroll your child in a trial, consult with your pediatrician or family physician about your child’s risk of experiencing side effects from the vaccine due to allergies or other underlying health conditions.
If I want to enroll my child in the Moderna trial, what do I need to do?
Dr. Lanerie: Parents who are considering enrolling children in the Moderna adolescent clinical trial can get more information, check eligibility, and sign up
here.
