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Evaluating new vaccines for developing countries. Efficacy or effectiveness?
1Division of Epidemiology, Statistics, and Prevention Research, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892, USA.
JAMA
|February 7, 1996
Summary
Vaccine effectiveness trials offer a pragmatic approach to evaluating new vaccines in real-world public health settings. These trials provide clearer cost-benefit data, accelerating vaccine adoption in developing nations.
Area of Science:
- Public Health
- Vaccinology
- Health Economics
Background:
- New vaccines for developing countries face adoption hurdles due to cost-benefit uncertainties.
- Prelicensure vaccine efficacy trials offer limited insight into real-world performance.
Purpose of the Study:
- To advocate for vaccine effectiveness trials over traditional efficacy trials.
- To highlight the benefits of effectiveness trials for public health decision-making in resource-limited settings.
Main Methods:
- Comparing vaccine efficacy trials (ideal conditions) with vaccine effectiveness trials (real-world conditions).
- Emphasizing the comprehensive outcome assessment in effectiveness trials, including direct and indirect effects.
- Focusing on practical cost-benefit analyses relevant to public health programs.
Main Results:
- Effectiveness trials provide a more pragmatic assessment of vaccine performance in routine public health programs.
- Effectiveness trials capture both direct and indirect impacts of vaccination.
- These trials address a broader range of public health outcomes.
Conclusions:
- Vaccine effectiveness trials facilitate rational vaccine selection for developing countries.
- Adopting effectiveness trials can expedite the implementation of new vaccines by resolving practical cost-benefit debates.