COVID-19, vaccines, adolescents, trial design, randomization, risks, benefits, monitoring, equipoise, standard of care, clinical trial, recruitment, consent
During the COVID-19 pandemic, many public health measures were imposed globally to slow the spread of the SARS-CoV-2 virus, including face masking, physical distancing, and hand washing. By early 2021, several vaccines had been developed and were granted emergency use authorization by the U.S. Food and Drug Administration and regulatory bodies in other countries. Adults (individuals 18 years of age and older) were encouraged to get vaccinated as a measure to control the disease and reduce hospitalizations and deaths.
As of June 2021, one COVID-19 vaccine was authorized as being safe and effective for adolescents 12-17 years of age.1 However, emerging reports noted vaccine-related complications of myocarditis in young adults and adolescent males. These complications, which occurred a few days after vaccination, were very rare, occurring at about 12 cases per million doses of vaccine.2 In most cases, the symptoms went away. Weighing risks and benefits, the World Health Organization recommended vaccination for this age group; however, practical concerns made this difficult. Many adults were still not vaccinated across low- and middle-income countries because of an inadequate supply of vaccines.
A pharmaceutical company wanted to conduct a clinical trial of their vaccine for adolescents 12-17 years of age. This vaccine was considered safe and effective for adults in many countries. The pharmaceutical researchers approached health officials in Malaysia, in which about 55% of the adult population was vaccinated but adolescent vaccination had yet to occur. The company then approached pediatricians at several hospitals with pediatric and adolescent clinical services to join the study and help recruit adolescents. Study participants would be randomized, with double blinding, to one of two study arms (placebo or study vaccine), and monitored for 6 months after vaccination. Shortly after these consultations, the country’s government announced that they would soon vaccinate adolescents 12-17 years of age with the already authorized adolescent vaccine, with priority to those who have health conditions that could worsen with COVID-19.
Questions
Should pharmaceutical researchers be permitted to conduct their clinical trials with adolescents in the country? Why or why not?
Is it ethically appropriate to randomize participants in the clinical trial? Why or why not? Would it be ethically appropriate for the study to randomize some of the adolescents to a placebo arm? Why or why not?
Are there concerns about recruitment and consent of adolescents in this study? How might the researcher address these concerns?
Are there concerns about the planned national vaccination program? How might these concerns be addressed?
What should be done if study participants become infected with SARS-CoV-2? What is the best way to ensure the health and safety of participants?
