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The Vaccine Efficacy Standard: Ethical And Policy Concerns In Light Of Emerging Vaccines, Vincent Y. Ling

Vincent Y. Ling

An efficacy showing is one prerequisite for market approval of vaccines in the United States. The Food and Drug Administration’s current standard for efficacy, however, is low and vague, which allows partially effective vaccines on the market. The use of partially effective vaccines poses an ethical dilemma, especially when more effective vaccines are, or will be, available. Non-regulatory forces contribute to a higher efficacy showing in practice, but more instructive efficacy regulation will be necessary as partially effective vaccines become a viable health care option. A growing emphasis on comparative effectiveness research under the Patient-Centered Outcomes Research Institute (“PCORI”), established …