Abstract Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care. Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines, reducing the global burden of coronavirus-related mortality and morbidity. Volunteers’ net risk in such studies could be acceptable under specific conditions.
【저자키워드】 coronavirus, Randomized controlled trials, Vaccines, Ethics, Human challenge studies, risk-taking, 【초록키워드】 Vaccine, Mortality, Trial, Infection, risk, SARS-CoV-2 vaccine, Adults, morbidity, death, natural infection, disease, Care, Live virus, Phase 3, severe disease, candidate, participant, vaccine candidates, Volunteer, healthy, reducing, reduce, Controlled, conditions, accelerate, replacing, receive, baseline, 【제목키워드】 Human, challenge, licensure,