Ethical considerations in post-market-approval monitoring and regulation of vaccines.

The objective of this paper is to identify and articulate ethical considerations to help guide decision-making around the regulation and monitoring of vaccines post-licensure. While these considerations are not intended to be an exhaustive account of the ethical concerns, they can facilitate the explicit examination of ethical issues in this context. We identify the protection of public from harm as the primary consideration, and identify others that help in the discharging of this governmental obligation. Others include: transparency, a publicly acceptable risk-benefit profile, public trust, minimization of stigma, and special obligations to vulnerable populations. Regulators and researchers can use these ethical considerations to help enhance their reasoning and to improve the accountability of their decision-making. These considerations can be used to inform rational deliberations about how to balance the obligation to protect the public from harm with other relevant considerations such as the need to be transparent, while taking into account the contextual features of the situation. Further research and debate on the relevance and refinement of these ethical considerations is desirable.