Issue Briefs • Vaccination Requirements and Exemptions • Informed Consent in Vaccination • The Vaccine Industry - An Overview • The Rationing of Vaccines Against Pandemic Influenza Evaluating Risk, Benefits, and Safety in Vaccine Policy • Risk-Benefit Analyses and Vaccine Safety Monitoring • Risk Communication and Related Ethical Considerations Vaccines against Potential Agents of Bioterrorism • Bioterror Threats and Vaccines against Anthrax and Smallpox • Obstacles Facing Bioterror Vaccine Development Vaccines for Tropical Diseases and Global Research Priorities • Neglected Tropical Disease Vaccine Candidates and Financing • Vaccine Research Priorities and Obstacles to Access The Quest for an HIV Vaccine • Challenges in HIV Vaccine Development - An Overview • Logistical and Ethical Considerations of HIV Vaccine Clinical Trials • HIV Vaccine Clinical Trials: The Standard of Care Debate

Evaluating Risk, Benefits, and Safety in Vaccine Policy
II. Risk Communication and Related Ethical Considerations

Risk Communication and Decision-Making

While a general aim of health policy to strive to maximize benefits and minimize risks, studies indicate that these decisions are rarely the result of strict quantitative assessments. A vast literature has shown that individuals perceive and respond to risks in a manner often quite different than its likelihood or severity would suggest.¹

By some, risks that are the result of specific actions - such as receiving a vaccine - are viewed as worse than risks that occur 'on their own,' as in infection with a vaccine-preventable disease. In a study published in the June 2006 Journal of General Internal Medicine, researchers explained that many people are willing to face higher risks of death to avoid potentially "causing harm," i.e. choosing that a vaccine be given.²

In 1996, the Institute of Medicine's Vaccine Safety Forum convened a workshop to study aspects of vaccine decision-making as well as risk communication. In discussions among government, academic, industry, and civic groups, three key themes surfaced:

1. "Risk communication is a dynamic process in which many participate, and these individuals are influenced by a wide range of circumstances, interests, and information needs."

2. "The goal that all parties share regarding vaccine risk communication should be informed decision-making."

3. "There is often uncertainty about estimates of risk associated with vaccination."³

As could be expected, an individual's background and values have a significant impact on his/her decision-making framework. High-quality risk communication must, therefore, be tailored to the diversity and context of an individual's experiences.⁴

Ethical Considerations

All discussion of risks and benefits points back to perhaps the most important goal of vaccination, the preventing of illness, suffering, and death. Discussions of efficacy and safety thresholds utilized in vaccine clinical trials introduce many ethical questions regarding their appropriate size and duration and the manner in which trial data is evaluated.

Arguments have been made for the expansion of typically-restrictive inclusion criteria, such as children with acute or chronic illness, to better reflect the heterogeneity of the population likely to receive the vaccine. Extended clinical trials would also detect any delayed adverse events and provide clearer information earlier as to the duration of immunity provided by an initial vaccine course. Advocates of larger and longer clinical trials note the potential of enhancing public confidence in vaccine safety.

However, expanding the size and duration of vaccine clinical trials would lead to major increases in their cost. These expenses would almost certainly be reflected in the price of newly licensed vaccines, a significant concern in a period when vaccine prices are already presenting major challenges for public and private payers. Moreover, the vaccine development process currently extends well over a decade for most new vaccines; extending it further would further delay the arrival of potentially beneficial vaccines to the public. The potential to generate meaningful data from enhanced clinical testing must be evaluated in light of these concerns.

Critics of the current pre- and post-licensure vaccine safety landscape have called attention to the absence of an independent safety board.^{5, 6} They suggest that the current regulatory structures lack a sufficient firewall between those charged with administering vaccination programs and promoting vaccines with those monitoring short- and long-term vaccine safety. A recent reorganization of offices working in and around vaccine policy has done little to assuage these concerns. Proponents of a National Vaccine Safety Board (NVSB) note that such a group would bring together experts from government, industry, and academic to provide timely investigation of adverse events and better determine causal associations. The NVSB would require independent funding to avoid the perception of conflicts of interests, but would ensure the public that vaccine safety issues are reported objectively.

Vaccine risk-benefit analysis in international public health raises additional, unique ethical considerations. Because the epidemiological profile of infectious disease varies widely among countries (and regions thereof), the benefits of vaccines may differ between developed and developing countries.⁷ Vaccine-associated risks that may be unacceptable in a country in which a disease is a minor threat may be more acceptable in countries where the disease is a greater source of morbidity or mortality. These types of analyses pose considerable challenges for health officials charged with communicating the differences in a vaccine's risk-benefit profile in different populations.

In the United States and around the world, the success of any vaccination program relies on gaining and preserving public trust, particularly among parents of children receiving recommended and required vaccines. A thoughtful and serious evaluation of the risks and benefits associated with vaccines and respectful communication about this topic among policymakers, healthcare workers, and parents is essential to the continued success of vaccination programs.

-- By Katelin Hoskins, University of Pennsylvania (hoskinsk@nursing.upenn.edu)

¹Spier RE. (2002). Perception of risk of vaccine adverse events: a historical perspective. Vaccine, 20: S78-S84.
²Zikmund-Fisher BJ, Sarr B, Fagerlin A & Ubel PA. (2006). A matter of perspective: choosing for others differs from choosing for yourself in making treatment decisions. Journal of General Internal Medicine, 21(6): 618-622.
³Center for Disease Control and Prevention. (2008). History of vaccine safety. Available at http://www.cdc.gov/vaccinesafety/basic/history.htm.
⁴Institute of Medicine. (1997). Risk communication and vaccination: workshop summary. National Academy Press: Washington, D.C.
⁵Chen RT. (1999). Vaccine risks; real, perceived, and unknown. Vaccine, 17: S41-S46.
⁶Salmon DA, Moulton LH & Halsey NA. (2004). Enhancing public confidence in vaccines through independent oversight of postlicensure vaccine safety. American Journal of Public Health, 94(6): 947-950.
⁷Coffin SE & Nelson RM. (2005). "Optimizing risks and benefits: the case of rotavirus vaccine." Ethics and Research with Children: A Case Based Approach. Ed. Kodish ED. Oxford University Press: USA.