No title page needed
APA 7
must use 3 scholarly resources in the last 5 years
read topic answer questions at the end
Topic: Case Study
A childhood vaccine for pneumococcal disease, one of the most important causes of child deaths in the developing world, has been developed by a European pharmaceutical company and tested at a site in Africa. The goal of the trial was to determine how many children would be protected from the disease before the age of 3 years. In this community, and in the region overall, approximately 90% of the childhood deaths caused by pneumococcal disease occur in children younger than 3 years. After community consultation and extensive efforts to obtain meaningful informed consent, 20 000 infants were enrolled in the vaccine trial. Participants were randomized and half received the trial vaccine. After 3 years, 90% of those who were vaccinated remained free of the disease. Those in the control group had infection and mortality rates comparable to those that prevailed in recent years in this population.
Ordinarily, vaccines and other interventions which are proven effective in a randomized placebo-controlled trial are offered to all participants in the control group soon after the conclusion of the trial. Some of the scientists in this study, however, became reluctant to follow that practice in this trial. Their concern was that the study provided a unique opportunity to determine whether the vaccine protected children who were older than 3 years; if the controls were vaccinated at the conclusion of the trial, an ongoing study in older children would have no controls. The same considerations applied to longer-term monitoring of adverse post-trial events. Both of these issues – protection of children older than 3 years, and long-term safety – might play a role in determining whether the vaccine would be widely used in the future, and many children’s lives might depend on the result. Moreover, if (as turned out to be the case) the results of the first trial were definitive for children aged 3 years and younger, it might be impossible to conduct any further controlled trial of the vaccine. This was, in the view of these scientists, a unique opportunity. Their concerns, however, were not incorporated into the study design, and all controls received the vaccine at the conclusion of the trial.
Adapted from a case study contributed by Dr. Brooke Ronald Johnson, World Health Organization
Questions
Were the dissenting scientists correct to urge that controls should not be vaccinated?
If the parents had agreed to this condition in the informed consent, would this justify not vaccinating the control group at the conclusion of the study?
If the randomized, placebo-controlled trial design was justified, why would it be unjustified to decline to vaccinate the controls?
Would any further test of the effect of these vaccines on children older than 3 years, and of long-term safety, be justified?
