SPECIAL ARTICLE
Risky Business: Challenges in Vaccine Risk Communication
Leslie K. Ball, MD*; Geoffrey Evans, MD‡; and Ann Bostrom, PhD§
ABBREVIATIONS. AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; IPV, inactivated polio vaccine; FDA, Food and Drug Administration; DTwP, diph-theria and tetanus toxoids and whole-cell pertussis vaccine; DTaP, diphtheria and tetanus toxoids and acellular pertussis vaccine; DTP, diphtheria, tetanus, and pertussis vaccine; CDC, Centers for Disease Control and Prevention; NCVIA, National Childhood Vaccine Injury Act; VICP, Vaccine Injury Compensation Program; IOM, Institute of Medicine; OPV, oral polio vaccine; VIS, Vaccine Information Statements.
C
oncern over vaccine safety has been a majordeterminant of immunization policy—from passage of the Biologics Control Act in 1902 to the recent American Academy of Pediatrics (AAP) and Advisory Committee on Immunization Practices (ACIP) recommendations for expanded use of inac-tivated polio (IPV) and acellular pertussis vac-cines.1– 4 With the availability of new vaccines and vaccination options comes the challenge of how best to communicate these options to patients and their parents. Lessons from the field of risk communica-tion on predictors of risk acceptability and vaccina-tion decision heuristics provide insight into why some parents resist vaccination. This article provides a historical perspective on vaccine adverse events and applies lessons from risk communication re-search to help physicians improve their ability to discuss vaccine risks.
HISTORICAL PERSPECTIVE
Immunizations have been described as the single most effective health intervention after clean water and sewage disposal,5 and have an extraordinary safety record. However, public policy has long re-flected concern for the safety of vaccines and related biologics. In 1902, Congress passed the Biologics Control Act in response to the death of 13 children
who had received injections of diphtheria antitoxin contaminated with tetanus toxin.6This act required biologics to be manufactured in a manner that as-sured their safety, purity, and potency. Responsibil-ity for these regulations was assigned originally to the Hygienic Laboratory of the Public Health Service, which evolved into the National Institutes of Health. The regulation of biologics including vaccines was transferred to the Food and Drug Administration (FDA) in 1972.
The first published accounts of serious adverse events after whole cell pertussis vaccine occurred in 1933 with Madsen’s7report of two deaths within 48 hours of immunization, and in 1948 with the report in Pediatrics by Byers and Moll8 of encephalopathy after diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine (DTwP). In 1955 the Cut-ter incident occurred, in which incompletely inacti-vated Salk vaccine was associated with over 200 cases of paralytic poliomyelitis.9 By the 1970s the incidence of many vaccine-preventable diseases had decreased significantly and concern over safety of whole cell pertussis vaccine surfaced in Japan and Europe.10 Pertussis immunization rates plummeted in several countries. Outbreaks of pertussis followed, leading to the development of an acellular pertussis vaccine (DTaP) in Japan.11
The pertussis debate raging in Europe and Japan reached the United States in 1982, when the Emmy
Award-winning television program, DPT: Vaccine
Roulette, was aired with allegations of serious neuro-logic sequelae after DTwP.12 This was followed by the publication of Coulter and Fisher’s book,DPT: A Shot in the Dark, in 1986.13 A dramatic increase in diphtheria, tetanus, and pertussis vaccine (DTP) lit-igation led to the withdrawal of several manufactur-ers from the marketplace. The Centmanufactur-ers for Disease Control and Prevention (CDC) began stockpiling DTP vaccine as a shortage loomed. With the nation’s health at stake, the National Childhood Vaccine In-jury Act of 1986 (NCVIA) was passed,14 after a col-laborative effort involving the AAP, consumer advo-cacy groups, and others. This act included several provisions relevant to vaccine safety, creating the National Vaccine Injury Compensation Program (VICP) and the Vaccine Adverse Event Reporting System and mandating comprehensive reviews of vaccine-related adverse events by the Institute of Medicine (IOM) and the development of vaccine in-formation materials.
From the *Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Mary-land; the ‡National Vaccine Injury Compensation Program, Health Re-sources and Services Administration, Department of Health and Human Services, Rockville, Maryland; and the §School of Public Policy, Georgia Institute of Technology, Atlanta, Georgia.
The views in this article are those of the authors and are not intended to represent those of their respective organizations.
This article was adapted from a presentation at the Annual Meeting of the American Academy of Pediatrics, Boston, MA, October 30, 1996. Received for publication Jul 10, 1997; accepted Aug 25, 1997.
Reprint requests to (L.K.B.) Food and Drug Administration, HFM #475, 1401 Rockville Pike, Rockville, MD 20852.
PRESENT DILEMMAS
The expanded role of DTaP and IPV vaccines in childhood immunizations is in direct response to vaccine safety considerations. Concerns about local and systemic reactions prompted the recent revisions to the ACIP and AAP acellular pertussis vaccine recommendations, despite the lack of data establish-ing conclusively a causal link between DTwP and serious sequelae.15After over a decade of research to develop less reactogenic pertussis vaccines for in-fants, the FDA licensed acellular pertussis vaccines for the fourth and fifth doses in 1992 and for the primary series in 1996.16 DTaP is now the preferred product, with DTwP an acceptable alternative dur-ing the transition period.2,4
Since 1980, an average of 8 to 9 cases of paralytic polio per year have been associated with the live, trivalent oral polio vaccine (OPV) in the United States, either through direct receipt or contact with a recipient.3In 1994, the Western Hemisphere was cer-tified by the World Health Organization to be free of indigenous wild polio.17The greatly diminished risk of acquired paralytic polio from wild poliovirus, ei-ther indigenous or imported, prompted a reevalua-tion of the risks of OPV-associated paralytic polio. After much debate, the AAP and ACIP have moved toward expanded use of IPV.1,3With the availability of new options comes the challenge of how to com-municate these options to our patients. Moreover, pediatricians are occasionally faced with parents who question the need for vaccinations altogether.
Why is vaccine risk communication so challeng-ing? Perhaps the most important factor may be the lack of disease awareness. The dramatic decline of vaccine-preventable diseases has inevitably de-creased public awareness of these illnesses, likely prompting greater reluctance to accept adverse reac-tions after vaccination. Another factor is the power of temporal association—ie, post hoc, ergo propter hoc— or what follows immunization must be caused by it. Neurologic sequelae after DTwP are one exam-ple of this logic. Although paralytic polio is a dem-onstrated risk after vaccination with OPV, many se-rious adverse events temporally associated with immunization lack a clear cause-and-effect relation-ship. In addition, vaccine risk communication is hampered by a lack of data. In 199118and 199419the IOM undertook extensive reviews of adverse events associated with childhood vaccines, and concluded that there was either no evidence or insufficient ev-idence to establish a causal relationship for two thirds of the conditions it studied. Moreover, experts often disagree about the interpretation of existing data, further confusing a public looking to science for answers. The rarity of an adverse event, the lack of defined clinical syndromes, and the absence of pathophysiological understanding limit investiga-tion into adverse events. For example, no specific clinical syndrome or neuropathology has been de-fined for DTwP encephalopathy, despite more than five decades of DTwP use.
Underlying this issue is the inherent tension be-tween protecting public health and allowing
individ-ual autonomy. Some consumer advocacy groups formed from the DTwP controversy of the 1980s maintain the importance of parental choice in vacci-nations.13However, the enactment of state laws man-dating immunizations for school entry, in large part responsible for wide vaccine coverage and the dra-matic drop in vaccine-preventable diseases, is in di-rect collision with free parental choice. Some health care practitioners also support the concept of choice in vaccinations. For example, a survey of American chiropractors found that 81% of respondents believe immunizations should be voluntary.20 Currently, most states permit religious exemptions to vaccina-tion requirements and 15 states permit philosophical exemptions (Joel Kuritsky, CDC, National Immuni-zation Program, unpublished data). Reconciling pa-tient empowerment with the goals of public health remains problematic.
The media and other sources of public information play a role in vaccine risk perception.21In 1994, me-dia reports incorrectly attributed deafness in Heather Whitestone, the former Miss America, to the DTwP vaccine, although her condition was later confirmed by her pediatrician to be the result of Haemophilus influenzae type b meningitis.22 The irony that her condition was caused by an illness now preventable by vaccination may have been lost on the American public because of the media fanfare surrounding the initial report. This episode underscores the fact that health professionals are not the only source of vac-cine information, which can come from family mem-bers, neighbors, and an array of media outlets such as newspapers, magazines, and television. More re-cently the Internet, with its home pages and elec-tronic bulletin boards, has emerged with vast poten-tial for information dissemination but without any editorial control, much less peer review.23Even when presented with accurate information, parents and physicians may differ in how they interpret data and make decisions on risk. What then are the determi-nants of risk perception, and what risk communica-tion approaches are available to the pediatrician?
RISK PERCEPTION AND PREDICTORS OF RISK ACCEPTABILITY
By and large, pediatricians are viewed as a credi-ble source of vaccine recommendations, a notion supported by a recent study of private pediatric practices that indicated provider behavior may be the most important determinant of immunization rates.24The majority of parents follow their pediatri-cian’s recommendation regarding immunizations, and may not engage in an independent decision-making process. However, a minority of parents question vaccination recommendations. For them, short explanations of risks and benefits may not suf-fice.
cognitive and social psychology, behavioral decision theory, and risk assessment and management, and has concentrated on environmental hazards includ-ing nuclear reactors,25chemical plants,26and radon.27 A broad review of risk communication was con-ducted by the National Research Council in 1989.28 Theories developed in this field have only recently been applied to vaccine risk communication.29
Of paramount importance is that individuals per-ceive risk differently. Although physicians may fo-cus on the statistics regarding general vaccine effec-tiveness and known risks of vaccine-preventable diseases, parents making vaccination decisions may perceive risks in a broader religious, cultural, and personal context. Individual characteristics affect de-cisions to vaccinate; data from the CDC tell us that immunization rates vary by race, education, socio-economic status, and other factors.30 For example, mistrust of the medical system by some African-Americans has been identified as a barrier to optimal health care and participation in clinical trials,31 and was highlighted by the Clinton Administration’s re-cent decision to issue a formal apology for the Tuske-gee Syphilis Study.32Confronting reasons for under-vaccination such as lack of access and missed opportunities may be easier than addressing issues of trust and cultural perspective.
Other attributes of risk also affect risk acceptability and may complicate parental risk decisions.33 Volun-tary, controllablerisks are more acceptable than invol-untary risks.29Consumer groups advocating greater parental choice in vaccination contend that state laws mandating vaccination for school entry render vac-cination an involuntary risk, and thus less accept-able.29 Researchers have uncovered another way in which the perception of control influences parental vaccination decisions. Meszaros et al34demonstrated that parents refusing vaccination were more likely than parents who vaccinated their children to agree with the statement, “[I]f there were no vaccination given to my child, I could prevent the disease.” Thus, some parents may not accept vaccination recommen-dations because they perceive control over events in ways not recognized by the pediatrician.
Additional factors may influence the acceptability of risks. Some risk communication researchers sug-gest thatnaturalrisks are generally more acceptable than man-made risks.35 At an IOM forum on polio vaccine policy, an advocate for alternative therapy argued that immunity acquired after natural infec-tion is often preferable to vaccine-induced.36 This logic neglects the often severe morbidity and mortal-ity associated with vaccine-preventable diseases, as well as the fact that some vaccine-preventable dis-eases induce no significant immunity (eg, tetanus). In addition, the acceptability of a risk is determined by whether it induces fear or dread and whether it is memorable. Any event adversely affecting the well-being of a child is dreaded, and risks that are mem-orable are more aversive than those that are not. For example, parents’ recall of the fever and fussiness after DTwP in their infant may influence their accep-tance of further vaccinations.
Finally, risk communication researchers have
demonstrated that some parents are unlikely to un-dertake a risk control measure unless they perceive both a serious threat and some control over the risk.37 When a perceived threat is low, individuals are un-likely to accept a health intervention regardless of the efficacy of that intervention. Thus, a decision to vaccinate is most likely to be made by a parent who recognizes the threat of vaccine-preventable illness and perceives vaccination as an appropriate resource to control that risk.
How risks are perceived depends, in part, on how the message is framed. Studies have shown that an option described in terms of benefits may result in a different decision than the equivalent option de-scribed in terms of risks.38,39 Applying this to vac-cines, risk communication that emphasizes lives saved by vaccination may be more effective in pro-moting vaccination than communication that men-tions the lives lost despite vaccination. In addition, the extent to which an individual perceives a health intervention as risky may determine how a message is processed and what action is taken.38Research in this area suggests that for parents who view vaccines as generally safe, emphasizing the benefits of vac-cines may be the most successful approach to en-courage vaccination. For those parents who question vaccine safety, a more effective approach may be to frame the decision in terms of the risks of illnesses preventable by vaccination.
VACCINE DECISION HEURISTICS
Because most risk decisions involve more informa-tion than can be processed readily, individuals tend to simplify. An intervention such as immunization is often categorized as safe or unsafe without acknowl-edging the spectrum in between. Heuristicsare cog-nitive shortcuts that people use to simplify complex decisions and judgments. Parents may use heuristics to quantify risk. In some cases, heuristics may result in a decision not to vaccinate.
The heuristics individuals use to make risky deci-sions includecompression, or overestimating the quency of rare risks and underestimating the
fre-quency of common risks.40 Concerns about DTP
encephalopathy and vaccine-associated paralytic po-lio, which are rare, may be increased by use of this heuristic. Moreover, theavailabilityof an event (one that is accessible or easily remembered) can lead to overestimation of its frequency; witness the effective-ness of sensationalized media reports alleging vac-cine injury.
vacci-nation was zero. Moreover, when given a choice, individuals tend toavoid ambiguity.43For example, a risk from a known disease may be more acceptable than an equivalent or smaller risk that is perceived as more ambiguous (eg, from a new vaccine). This heu-ristic may be operative in some parents’ avoidance of the varicella vaccine. Some parents who withhold vaccinations may use freeloading logic, relying on high vaccination rates and herd immunity to protect their unvaccinated child.29
Some heuristics may work in favor of vaccinations. Bandwagoningis the tendency for parents to vaccinate if “everyone else is doing it,” without fully evaluat-ing the options themselves.34 Altruistic individuals are willing to accept personal risk if society as a whole will benefit (ie, herd immunity).
EFFECTIVE VACCINE RISK COMMUNICATION STRATEGIES
Effective risk communication has four compo-nents. First, it communicates existing knowledge, taking into account what individuals already know. Second, successful risk communication recognizes factors influencing parental risk perception and ad-dresses vaccine decision heuristics. Third, it ac-knowledges potential risk communication pitfalls. Finally, effective risk communication engages ents appropriately, which for active, concerned par-ents means a decision-making partnership with their physician.
Because belief systems are difficult to change once established, it is appropriate to provide parents with understandable, reliable information on vaccines at the outset so their first impression is correct. What vaccine risk communication tools exist today? The NCVIA mandated that vaccine administrators pro-vide parents with written information materials de-tailing the benefits and risks of childhood vaccina-tions. These initially took the form of Vaccine Information Pamphlets, developed by the CDC and implemented in April 1992. The AAP, among others, argued that these pamphlets were unnecessarily long and confusing to parents,44and an amendment to the NCVIA led to the shorter, simplified Vaccine Infor-mation Statements (VIS) adopted in October 1994. Vaccine administrators are required by law to pro-vide VIS for vaccines covered by the VICP. Of note, the VIS should not be construed as informed consent, as informed consent requirements are determined by state law. State laws dictate whether informed con-sent is required before vaccination, whether in-formed consent must be oral or in writing, and whether additional vaccine information must be pro-vided (Kevin Malone, CDC, Office of General Coun-sel; personal communication). Although the VIS have been hailed as an improvement, they have been criticized for requiring too high a reading level for some parents, and not providing enough informa-tion for others. Clearly, one size does not fit all.
To overcome these shortcomings, experts in risk communication recommend layering information ac-cording to individual needs. An option for future vaccine information materials includes providing multiple levels of information that can be targeted to
various audiences. Most importantly, the VIS and other vaccine information materials cannot replace the dialogue between pediatrician and parent but can be viewed as a starting point.
If a pediatrician does not possess the knowledge to answer a parent’s particular question, referral to ap-propriate resources should be made. Technical infor-mation on vaccines and vaccine-preventable diseases can be found in the AAP Committee on Infectious Diseases’Red Book, the ACIP’sReports and Recommen-dations of the Morbidity and Mortality Weekly Report, and the manufacturers’ package inserts. The CDC has developed a pamphlet directed at providers for addressing common misconceptions on vaccines such as the existence of DTP hot lots or that the immune system can be overloaded by simultaneous immunization with multiple vaccines.45 In addition, information on vaccines can be found on CDC’s Na-tional Immunization Program Internet home page at http://www.cdc.gov/nip/home.htm.
Second, effective risk communication acknowl-edges factors influencing risk perception and risk acceptability, and addresses heuristics. Parents ex-pressing a reluctance to vaccinate their children re-quire more than a quantitative analysis of the risks and benefits; physicians should seek to understand the cultural, religious, and other personal factors influencing vaccination decisions. Vaccination deci-sions are likely to be improved if physicians educate parents about the risks of diseases and encourage parents to participate in and control vaccination de-cisions. Message framing can influence parental vac-cination decisions, but as discussed above, its effects are likely to depend on parents’ prior beliefs and perceptions of risks and benefits.
Successful risk communication also addresses vcine decision heuristics. Providing parents with ac-curate risk data is the first step toward correcting compression and other biases in estimating risks. One approach suggested by risk communication re-searchers to overcome the omission bias is to reframe the vaccination decision from the viewpoint of the child. Baron46found that individuals opposed to vac-cination could be persuaded to vaccinate if they placed themselves in the child’s position and then asked themselves whether they preferred a greater or lesser chance of death, and whether it mattered if the outcome occurred as a result of someone’s act or omission. Parents can be educated on the limits of freeloading by discussing the incidence of vaccine-preventable diseases in unvaccinated populations. Because risks which are easily accessible to the imag-ination are more compelling, examples given in the context of a personal story can be persuasive. For example, parents reluctant to vaccinate against per-tussis can be told of pediatrician’s personal experi-ence treating children hospitalized with pertussis.
information for fear of sending a mixed message to parents. However, pediatricians are a trusted source of information and are well-situated to address safety concerns that parents are likely to pick up elsewhere. Other potential pitfalls include the use of risk comparisons, comparing, for example, the risk of a serious vaccine reaction with the risk of being struck by lightning. Risk communication researchers argue that risk comparisons often backfire39; these comparisons may be confusing and may appear to belittle a parent’s concerns. Finally, some physicians adopt the paternalistic “Me Doctor Me God”50 ap-proach to dictate vaccine choices to their patients. In addition to the stylistic deficiencies of this approach, one study demonstrated a higher litigation rate in primary care physicians who deemphasized patient education and provider-patient communication.51
Finally, effective risk communication strategies en-tail a decision-making partnership between the pe-diatrician and parent.28Although some parents may want to follow their pediatrician’s advice, others may want to make their own decisions, using infor-mation provided by their pediatrician. Recent AAP and ACIP polio vaccine guidelines recommend in-forming parents or caregivers of the three acceptable polio vaccine regimens, allowing greater latitude for parent-provider choice. Increasingly, parents are concerned with process as well as outcome, and they want to be part of the decision-making process. At the heart of this partnership is the understanding by parents that they retain some control, as well as ultimate responsibility, for their child’s health.
FUTURE CHALLENGES
Ultimately, whose responsibility is risk communi-cation? Public health clinics, which administer.50% of childhood immunizations in the United States, are often not structured to handle such discussions. Vac-cine manufacturers develop package inserts and pro-motional brochures but lack the means for engaging in a direct dialogue with the public. Pediatricians, while ideally situated to communicate the benefits and risks of vaccinations, are faced with ever-in-creasing demands on their time, and lengthy discus-sions about risk are unlikely to be covered by capi-tation payments or third-party payers. In the final analysis, however, the responsibility for vaccine risk communication rests on the pediatrician or primary care provider who recommends vaccination.
Additional challenges remain. Licensure of new vaccine products will further crowd an already full immunization schedule and may complicate risk communication efforts. Innovative technologies in the pipeline such as DNA vaccines may streamline vaccine combinations and diminish the need for booster doses, but present the theoretical safety ques-tions of integration into host genome and the pro-duction of anti-DNA antibodies.52 Recent media re-ports alleging injury after vaccination53and scientific studies linking vaccination with chronic disease54 at-test to the need for further research on vaccine ad-verse events. Pediatricians must assimilate ever-in-creasing data on vaccines and apply principles of
risk communication in order to translate AAP and ACIP vaccine recommendations into actual practice.
SUMMARY
Vaccine risks, whether rare or common, scientifi-cally documented or not, can affect public attitudes toward immunization and influence public policy. Individual resistance to vaccination arises from many factors, including declining disease rates, sci-entific uncertainty, and the desire for individual au-tonomy. Explanations of vaccine benefits and risks are necessary but not sufficient to ensure effective risk communication. Risk communication research describes predictors of risk acceptability and vaccine decision heuristics that can help pediatricians under-stand the reluctance of some parents to vaccinate their children. Effective risk communication ac-knowledges these factors, avoids potential pitfalls, and engages parents appropriately in vaccination decisions.
ACKNOWLEDGMENTS
We thank Edgar Marcuse, MD, MPH, Bascom Anthony, MD, and Robert Ball, MD, MPH, for their invaluable comments on the manuscript.
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DOI: 10.1542/peds.101.3.453
1998;101;453
Pediatrics
Leslie K. Ball, Geoffrey Evans and Ann Bostrom
Risky Business: Challenges in Vaccine Risk Communication
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DOI: 10.1542/peds.101.3.453
1998;101;453
Pediatrics
Leslie K. Ball, Geoffrey Evans and Ann Bostrom
Risky Business: Challenges in Vaccine Risk Communication
http://pediatrics.aappublications.org/content/101/3/453
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