As the pandemic continues, COVID-19 has tragically claimed the lives of 172 children in the U.S., prompting Moderna to seek approval for its vaccine specifically for younger populations. However, the company is encountering difficulties in enlisting sufficient volunteers for its trials involving adolescents.
Moderna is currently conducting a study for teens aged 12 to 17, but participation rates have been disappointing, potentially hindering the timeline for vaccine authorization for this age group. The U.S. Food and Drug Administration (FDA) recently approved the Pfizer-BioNTech vaccine for individuals aged 16 and 17, while Moderna’s vaccine remains authorized only for adults aged 18 and older, as reported by USA Today.
According to Moncef Slaoui, the scientific advisor for Operation Warp Speed, the trial requires at least 3,000 participants to ensure safety and secure FDA approval. Unfortunately, the current enrollment is averaging only about 800 volunteers per month. “It’s crucial for everyone in America to understand that we cannot achieve this indication unless adolescents aged 12 to 18 choose to participate,” Slaoui stated.
Once enough participants are enrolled, the study will evaluate the vaccine’s efficacy in adolescents starting from age 12. Moderna’s CEO, Lisa Harper, indicated to CNBC that she anticipates the trial will conclude by September, with plans to initiate research involving children aged one to 11 “soon,” though results for this younger age group may not be available until 2022.
The impact of COVID-19 on children has been significant, with at least two million minors diagnosed with the virus in 2020, despite the fact that severe cases are relatively rare in this demographic. However, the broader implications of the pandemic on children’s lives—such as disruptions to in-person learning and extracurricular activities—are concerning. The American Association of Pediatrics emphasized the urgent need for more data regarding the long-term effects of the pandemic on children’s physical, emotional, and mental health.
Volunteers who decide to participate in the study will be monitored by medical professionals over 13 months. If you are interested in learning more about the trial and considering enrollment for your child, you can find additional information here. To qualify, participants must be between the ages of 12 and 17, have never tested positive for COVID-19, and be in good health.
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In summary, Moderna is striving to recruit enough adolescents for its COVID-19 vaccine trials but is facing significant challenges in enrollment. The urgency for participation is clear, as the approval of the vaccine for younger age groups could play a crucial role in combating the pandemic’s effects on children and adolescents.