Issue Briefs • Vaccination Requirements and Exemptions • Informed Consent in Vaccination • The Vaccine Industry - An Overview • The Allocation of Vaccines during an Influenza Pandemic Evaluating Risk, Benefits, and Safety in Vaccine Policy • Risk-Benefit Analyses and Vaccine Safety Monitoring • Risk Communication and Related Ethical Considerations Vaccines and Bioterrorism • Bioterror Threats and Vaccines for Anthrax and Smallpox • Obstacles to 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 goal of all health policy decisions is to maximize benefits and minimize risks, such decisions are rarely the result of strict quantitative assessments. Regarding vaccine policy, research on vaccine safety suggests that individuals perceive and respond to risks in a manner beyond what their likelihood or severity would suggest.¹

For 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,' such as an infection with a vaccine-preventable disease. (This distinction is sometimes referred to as 'acts of commission' vs. 'acts of omission.') 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 individual perspectives and experiences.⁴

Ethical Considerations

All discussion of risks and benefits begins with the most central goal of vaccination, the prevention of disease. Discussions of efficacy and safety thresholds in vaccine clinical trials introduce many ethical questions regarding appropriate size, duration, and analysis of research data.

A criticism of vaccine clinical research is the strict inclusion criteria for eligible subjects. Some advocate the participation of children with acute or chronic illnesses--typically excluded from these trials--in order to better represent the actual population to whom vaccines will be given. Others wish to extend the duration of Phase III trials to better detect delayed adverse events and provide clearer information as to a vaccine's long-term effects. Advocates of larger and longer clinical trials note the potential of such reforms in increasingly public confidence in vaccine safety.

However, expanding the size and duration of these trials would also lead to major increases in their costs. The expenses would almost certainly be reflected in the price of newly licensed vaccines, prices which already present major challenges for public and private sources of vaccine financing. Moreover, the vaccine development process currently lasts well over a decade for most new vaccines. Extending it would further delay the arrival of potentially beneficial vaccines to the public. The prospect of generating meaningful data from expanded clinical testing must be evaluated in light of these concerns.

Critics of the current pre- and post-licensure vaccine safety landscape have long called attention to the absence of an independent safety board.^{5, 6} Without one, it is argued, vaccine regulation lacks a necessary firewall between those tasked with administering and promoting vaccination programs and those responsible for monitoring short- and long-term vaccine safety. A recent reorganization of vaccine-related departments at the Centers for Disease Control and Prevention (CDC) did little to assuage these concerns.

In 2008, the National Vaccine Program (NVP) assembled a Vaccine Safety Working Group (VSWG) set "to review the CDC Immunization Safety Office Scientific Agenda, while engaging citizens and stakeholder groups to review the agenda."⁷ The VSWG has brought together experts from government, industry, and academia to promote a system providing for timely investigations of adverse events and causal associations. It also invites the public to contribute to its deliberations, an opportunity seen by the group's organizers as important to building public trust in its work.

Vaccine risk-benefit analysis in international public health raises unique ethical considerations. Because the epidemiological profile of infectious disease varies widely among countries (and in regions thereof), the benefits of vaccines may differ between developed and developing countries.⁸ A vaccine-associated risk that is deemed unacceptable in a country where disease incidence is low may be evaluated quite differently in nations where the disease is more common or more deadly. These types of analyses pose considerable challenges for health officials charged with communicating the differences in a vaccine's risk-benefit profile among different populations.

In the United States and around the world, the success of any vaccination program relies on gaining and preserving public trust. 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 are essential to the continued success of vaccination programs.

-- By Katelin Hoskins, University of Pennsylvania (hoskinsk@nursing.upenn.edu); Updated July 2010

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.
⁷ Final NVAC Recommendations on the Centers for Disease Control and Prevention Immunization Safety Office Draft 5-Year Scientific Agenda. Approved June 2, 2009. Available for download at: http://www.hhs.gov/nvpo/nvac/vaccinesafety.html
⁸Coffin 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.