Routine rotavirus vaccination of infants, when implemented broadly, is safe and is associated with reductions in diarrhea-related hospitalizations, mortality, and morbidity (such as malnutrition) in children.
Bioethicists and researchers say it may be possible to shorten the typical 15-year-plus vaccine timeline through a challenge trial. In this model, participants receive the study vaccine, the are deliberately exposed to SARS-CoV-2. Safety and efficacy are important, but the risk-benefit balance for study participants is weighed more heavily in favor of the greater public good.
Informed consent, protection of human subjects, fairness of testing, and eventual distribution: These all are important ethical questions and considerations surrounding the development of a COVID-19 vaccine.
IRBs have learned that their disaster plans did not prepare them for the effects of a fast-moving virus, COVID-19, that has demonstrated its far-reaching ability to shut down normal business and social interactions.