© 2004 American Public Health Association
E. J. Woo, R. Ball, S. V. Shadomy, and M. Braun are from the Vaccine Safety Branch, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md. S. V. Shadomy currently works at the National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Ga. A. Bostrom is from the School of Public Policy, Georgia Institute of Technology, Atlanta. At the time of the study, L. K. Ball was with the Office of Public Health and Science, Department of Health and Human Services, Rockville. G. Evans is from the National Vaccine Injury Compensation Program, Health Resources and Services Administration, Department of Health and Human Services, Rockville. Correspondence: Requests for reprints should be sent to Jane Woo, MD, MPH, HFM-222, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852 (e-mail: wooj{at}cber.fda.gov).
Objectives. We investigated vaccine risk perception among reporters of autism to the Vaccine Adverse Event Reporting System (VAERS). Methods. We conducted structured interviews with 124 parents who reported autism and related disorders to VAERS from 1990 to 2001 and compared results with those of a published survey of parents in the general population. Results. Respondents perceived vaccine-preventable diseases as less serious than did other parents. Only 15% of respondents deemed immunization extremely important for childrens health; two thirds had withheld vaccines from their children. Conclusions. Views of parents who believe vaccines injured their children differ significantly from those of the general population regarding the benefits of immunization. Understanding the factors that shape this perspective can improve communication among vaccine providers, policymakers, and parents/patients.
Despite scientific evidence that vaccination does not cause autism,111 many people continue to believe that a causal association exists. Particularly after a case series12 concerning measlesmumpsrubella vaccine (MMR), autism, and gastrointestinal symptoms received wide publicity, the public became concerned about a possible link. Understanding peoples mental models13 of autism, that is, their existing understanding and prior beliefs about vaccines and autism, might help to improve communication about vaccines among vaccine providers, policy makers, and parents/patients. To contribute to this understanding, we identified Vaccine Adverse Event Reporting System (VAERS) reports of autism and related disorders, telephoned those VAERS reporters, and conducted structured interviews to characterize their risk perceptions.
VAERS VAERS was established in 1990. It is jointly managed by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) and receives more than 14 000 reports annually. Reports are submitted by health care providers, vaccinees, manufacturers, and others. Passive surveillance systems, such as VAERS, are subject to many limitations, including underreporting, incomplete information in many reports, inadequate denominator data, and lack of an unbiased comparison group.14,15 Therefore, it usually is not possible to determine causal associations between vaccines and adverse events from VAERS reports. However, for a follow-up study designed to improve scientific understanding, VAERS can serve as a registry of neurodevelopmental disorders after vaccination.
Subject Selection
Survey Instrument To test the clarity of the survey instrument, we conducted pilot interviews with 16 reporters of autism and related disorders. No major problems were identified with the survey, and only minor modifications were made. Therefore, data collected during the pilot study were analyzed with the rest of the data. A contractor with experience in health surveys was hired and trained to conduct interviews and to perform data entry. From January 2001 to May 2002, the investigators and trained medical interviewers conducted structured interviews. As many as 10 attempts were made to reach each reporter: 3 on weekdays, 4 on weeknights, and 3 on weekends. For quality control, FDA personnel monitored a subset of the interviews and the data entered.
Data Entry and Analysis To assess whether report or reporter characteristics changed after the promulgation of news relating to autism and vaccines, we analyzed data by the date that VAERS reports were received. The highly publicized case series about vaccines and autism was published in February 1998.12 In July 1999, the American Academy of Pediatrics (AAP) and the US Public Health Service recommended that manufacturers remove or reduce thimerosal in vaccines.11 Two separate date stratifications1 with March 1, 1998, as a cutoff and 1 with August 1, 1999, as a cutoffwere performed.
Subject Selection We identified 351 VAERS reports from July 1, 1990, to July 10, 2001, with Coding Symbols for a Thesaurus of Adverse Reaction Terms or symptom descriptions that suggested autism or a related disorder. One hundred sixty-four originated outside the United States or had no locating information. Of the 187 with contact information available, 36 of the reporters could not be contacted, 26 refused to participate, and 1 stated that her child had never had any autistic symptoms. The study included 124 reporters who agreed to participate.
Characteristics of Respondents, Subjects of Reports, and Vaccines
Reports.
Twenty-seven (21.8%) reports were received from July 1, 1990, to February 28, 1998; 12 (9.7%) were received from March 1, 1998, to July 31, 1999; and 83 (66.9%) were received from August 1, 1999, to July 10, 2001. The date of receipt in VAERS was missing from 2 (2%) reports. Vaccination date for these 124 children peaked in 1997 (Figure 1
Subjects of reports. The majority of children were male (85.5%). The average age at symptom onset was 19.9 months (SD = 19.16 months), with a median of 15.4 months and 8 missing values, but there was substantial variability (range 2 months to 8 years). Autism and related disorders. Three quarters of reporters (75.0%) stated that their child had been diagnosed with autism or autism spectrum disorder, 4.0% reported a diagnosis of mental retardation, and 38.7% stated that their childs diagnosis was a developmental delay that was not otherwise specified. The diagnoses were not mutually exclusive. Vaccines. Almost two thirds of the VAERS reports (81 reports, 65.3%) listed MMR or its component vaccines. MMR or measlesrubella (1 report) was the only vaccine listed on 22 reports (17.7%); on 59 reports (47.6%), it was listed in conjunction with other vaccines, the most common of which were Haemophilus influenzae type B, oral live polio, diphtheriatetanusacellular pertussis, and varicella. On the 43 reports (34.7%) that did not list MMR or any of its component vaccines, diphtheriatetanuspertussis, diphtheriatetanusacellular pertussis, Haemophilus influenzae type B, and oral live polio vaccine were the most commonly reported vaccines. Parent interviews confirmed which vaccines the child had received in relation to the reported symptoms. Reports received on March 1, 1998, or later were somewhat more likely to list MMR (67.0% vs 59.3%) than reports received earlier. Reports received on August 1, 1999, or later were more likely to list hepatitis B (18.1% vs 5.1%), Haemophilus influenzae type B (38.6% vs 28.2%), and diphtheriatetanusacellular pertussis (26.5% vs 12.8%) vaccines than reports received earlier. Because manufacturer names and lot numbers were missing from the reports, it was not possible to determine from these VAERS reports how many of the case-patients received thimerosal-containing vaccines that had been distributed to clinics before the request was issued.
Making the Association Between Vaccination and Autism and Related Disorders
The later the reports were received in VAERS, the more likely the respondents were to cite explicitly a temporal association between the childrens symptoms and vaccination. The percentage of reporters who volunteered this reason was 14.8% for reports received before March 1, 1998, and 36.8% for those received later. The percentage of respondents who cited temporal association between the childrens symptoms and vaccination was 17.9% for reports received before August 1, 1999, and 38.6% for those received later.
Factors That May Have Contributed to the Reported Condition
Perceived Relative Importance of Immunization
Reasons to Immunize
Omitting Vaccines
Perceptions of Disease Severity and Likelihood of Infection
Perceptions of Immunization Safety
Key Beliefs About Vaccination
Credibility of Key Sources of Information Respondents were asked to use a scale of 0 (not at all familiar) to 10 (extremely familiar) to indicate their familiarity with various organizations as sources of information about childhood immunizations. For organizations for which the familiarity score was at least 5, respondents were asked to use a scale of 0 (not at all trustworthy) to 10 (extremely trustworthy) to indicate how trustworthy each organization was as a source of such information. The median familiarity score for the CDC of 7.0 (mean 6.1) was similar to scores for the National Vaccine Information Center, a consumer advocacy group (median 7.0, mean 6.3), and the AAP (median 6.0, mean 5.6). The National Resource Center for Immunization Information, a fictitious organization that Gellin et al. devised as a reference point for the ratings of existing organizations, was as unfamiliar to the VAERS reporters as it was to parents in the general population16; 73% of both groups reported that they were not at all familiar with it. The National Vaccine Information Center was considered a more trustworthy source of immunization information (median trustworthiness score 8.0, mean 7.2) than the CDC (median 5.0, mean 5.0) and the AAP (median 5.0, mean 4.9). In contrast, parents in the general population considered the CDC and AAP to be very trustworthy (mean rating of 8.5 for each).16 Respondents used the same scales to rate the familiarity with, and trustworthiness of, various organizations as sources of information about autism. The Autism Research Institute was a familiar source of information about autism, with a median familiarity score of 8.0 (mean 7.2), as were the Autism Society of America (median 8.0, mean 6.5) and Cure Autism Now (median 7.0, mean 6.0). Families for the Early Treatment of Autism (median 4.0, mean 4.3), the National Alliance for Autism Research (median 2.5, mean 3.7), and Center for the Study of Autism (median 2.0, mean 3.1) were relatively unfamiliar. The Autism Research Institute was considered to be highly trustworthy as a source of information about autism (median 9.0, mean 8.3), as were Autism Society of America (median 8.0, mean 7.6), and Cure Autism Now (median 8.0, 7.4).
We set out to describe perceptions of individuals who believe that vaccination caused their childrens autism or related disorder. Three features of these perceptions stand out. First, these parents based their beliefs on their own observations and the temporal association between vaccination and signs and symptoms such as fever, rash, or changed behavior. Media reports reinforced these perceptions. Second, respondents had relatively little trust in the institutions that shape immunization policy. Third, our respondents perceived vaccine-preventable diseases as less serious and less infectious than other parents did and based their decisions on these perceptions. These findings present several challenges and opportunities, which are highlighted in the following discussion.
Factors Contributing to the Perception of a Link Between Vaccination and Autism Approximately three quarters of the VAERS reports were received after the original case series was published,12 and two thirds were received after the AAP/US Public Health Services thimerosal recommendation.11 Respondents whose reports were received after the original case series was published were more likely than earlier reporters to cite the MMR vaccine as a contributing factor. One respondent specifically mentioned the Wakefield case series12 as a reason to attribute her childs symptoms to a vaccine; her VAERS report, which was received 2 years after the article was published, listed MMR as the sole vaccine. Lingam et al. reported that parents who had observed regression in their autistic childrenrather than delayed developmentwere more likely to speculate about the MMR vaccine and other possible causes of autism.17 Because of extensive media coverage, some respondents may have concluded that the reported association was not merely plausible but likely. Similarly, respondents whose reports were received after the AAP/US Public Health Services recommendation on thimerosal11 were more likely than earlier reporters to say that thimerosal/mercury had contributed to their childrens symptoms. Approximately one fifth of the VAERS reporters interviewed said that a Web site had made them think that their childrens symptoms might be related to a vaccination, and many others had searched the Internet for information about autism and related disorders. That the interval between the vaccination date and report date decreased over time demonstrates a secular trend in the perception that autism might be associated with vaccines. Specifically, the longer interval for reports with vaccination dates in the early 1990s suggests that publicity surrounding the original case series and thimerosal recommendation stimulated some parents to submit VAERS reports several years after their children were diagnosed with autism. These findings illustrate that the media and the Internet influence parental perceptions of vaccine safety and reinforce the need to develop fair and effective ways to communicate with the public about the benefits and risks of vaccines.
Trust of Institutions Promoting Vaccination
Perceptions of Severity and Likelihood of Infection and Vaccine Efficacy and Safety
We thank Elizabeth Begier, Susan S. Ellenberg, and Aparna K. Mohan for critical review of the manuscript. We thank Bruce G. Gellin, Edward W. Maibach, and Edgar K. Marcuse for allowing us to use some of their survey questions. We thank Battelle Center for Public Health Research for assistance with interviews, correspondence, and data entry. We also greatly appreciate the efforts of the VAERS Working Group for their dedication to the maintenance of VAERS. The members of the VAERS Working Group include the following: Elizabeth Begier, Dale R. Burwen, David Davis, Ann W. McMahon, Phil Perucci, Lise Stevens, Frederick Varricchio, and Robert Wise (FDA); Scott Campbell, Robert Chen, Penina Haber, Alena Khromova, Elaine Miller, Gina T. Mootrey, Robert Pless, Vitali Pool, Ali Rashidee, and Michelle Russell (CDC); and Vito Caserta (Health Resources and Services Administration).
Human Participant Protection
Contributors M. Braun conceived the study and supervised its implementation. E. J. Woo and S. V. Shadomy conducted interviews. E. J. Woo synthesized analyses and, along with R. Ball, led the writing. A. Bostrom, L. K. Ball, and G. Evans interpreted the findings with regard to risk perception theory. All authors helped to conceptualize study design, develop the survey instrument, interpret findings, and review drafts of the article. Accepted for publication January 14, 2004.
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