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COVID-19 Vaccine Makers Need Children to Participate in Clinical Trials
By Jessica Lanerie, M.D.
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, is in need of 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, it is still important to obtain vaccine data for all age groups. According to the scientists at Operation Warp Speed, the U.S. government’s vaccine effort, the Moderna teen trial is getting about 800 volunteer signups per month, compared to the adult trial signups of 800 per day. At least 3,000 adolescent participants are required to complete the trial.
The Moderna vaccine was authorized by the FDA in December for people 18 and over, but people under 18 may need a lower dosage, which is why a teen trial is necessary. Clinical trials for children 11 and younger will take even longer than the teen trials, with clinical data not anticipated until 2022.
Why Teens and Younger Should be Vaccinated
COVID-19 typically leads to a milder illness in children and adolescents when compared to adults, but severe and fatal illness is possible. According to the CDC, as of Dec. 31, 2020, there have been 179 COVID-related deaths of children in 43 states and New York City. That is approximately 0.06% of COVID deaths. There is also growing concern that even a mild initial COVID-19 infection could lead to long-term complications in both adults and children.
As of Jan. 7, 2021, around 2.3 million children in the U.S. have tested positive for COVID-19, and anyone who has the virus can spread it to others. While younger people should get vaccinated for their own health, doing so will also greatly reduce the chance of them transmitting the virus to others.
According to the American Academy of Pediatrics, there’s also an urgent need to collect data on the impact of the virus on children and adolescents to better understand the long-term physical, emotional, and mental effects. As with all vaccine clinical trials, determining side effects is another important part of the study.
As it stands, the American Academy of Pediatrics cannot recommend either the Moderna or the Pfizer-BioNTech COVID-19 vaccine for those under 16 because there isn’t a large enough sample of clinical trial participants to ensure safety and efficacy (the Pfizer-BioNTech vaccine has been approved for people 16 and older, but the Moderna vaccine has not). Because of the lack of data, it’s currently impossible to say when the vaccine will be available to children.
The bottom line: If enough adolescents and children do not volunteer for the clinical trials, the vaccine cannot be approved by the FDA for emergency use in people under 16. And because herd immunity isn’t probable until 70%-80% of the population is immunized, without children and adolescents getting vaccinated, herd immunity may not be possible.
Obstacles to Adolescent Trial Participation
It’s understandable that parents may not want to put children at risk by having them volunteer for vaccine clinical trials. However, experts say that the risk of side effects or illness in younger people is significantly less than in adults. The vaccine has an excellent safety profile in adults.
As with most medical decisions, children under 18 need parental consent to sign up for vaccine clinical trials. Before deciding whether or not to enroll your child in a trial, consult with your pediatrician or family physician about your child’s risk of experiencing severe side effects from the vaccine due to allergies or other underlying health conditions.
Parents who are considering enrolling children in the Moderna adolescent clinical trial can get more information, check eligibility, and sign up here.