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4 Stakeholder Concerns Related to the Safety of the Immunization Schedule Immunizations represent a unique health intervention because they simultaneously affect the health of individuals and the health of their com- munities. The success of vaccination programs in reducing the human res- ervoir of infectious diseases requires the collaboration and participation of a complex system of stakeholders in which each plays a specific role. These stakeholders include but are not limited to the parents of children who receive vaccines, the physicians and other health care professionals who deliver inoculations, and public health professionals who ensure vaccine delivery and safety. The concerns that surround the immunization schedule are equally complex and diverse. Concerns about vaccines have historically had a significant impact on the immunization system. Decreases in measles, mumps, and rubella (MMR) vaccine coverage in the United Kingdom are largely attributed to parental fears of autism linked to immunization with MMR following publication of the discredited Wakefield paper, which falsely claimed to demonstrate this association and was subsequently retracted years later by Lancet (Brown et al., 2012; Madsen and Vestergard, 2004; Taylor et al., 1999). In the 1970s, concerns about adverse effects from the whole-cell pertussis vaccine contributed to a decrease in uptake and halted pertus- sis vaccination programs in some countries. From this controversy came innovation that created the acellular pertussis vaccine, which has fewer observed adverse effects, as well as policy changes in the United States with the enactment of the National Childhood Vaccine Injury Act (IOM, 1992; Noble et al., 1987). The committee recognized the challenge and importance of identifying 59

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60 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY and understanding the range of stakeholder concerns about the childhood immunization schedule and its safety. To gain a fuller understanding of this system, the committee developed a strategy to gather and analyze stake- holder concerns, which included a review of the existing literature, listening to public testimony, and soliciting comments on a commissioned paper. IDENTIFICATION OF STAKEHOLDERS Given the committee’s charge, the first step was to identify stakeholders whose concerns focused on the safety of the immunization schedule rather than the safety of individual vaccines or nonsafety issues such as cost or convenience. To begin, the committee consulted the list of stakeholders from the 2008 Institute of Medicine (IOM) report Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office (IOM, 2008), which is also referenced in the 2010 National Vaccine Plan of the U.S. Department of Health and Human Services. As a second step, the committee categorized the extensive list of stakeholders by their general interest in immunization (Box 4-1). BOX 4-1 Stakeholders in the U.S. National Vaccine System • Academic researchers • Advocacy groups •  ederal government agencies, departments, and federal advisory F committees • General public (including parents) • Health care system and providers • International organizations • Media • Nongovernmental organizations • Philanthropic organizations • State, local, and tribal governments and public health agencies • Travel industry • Vaccine distributors • Vaccine industry • Vaccine investors SOURCES: IOM (2008) and adapted from the 2010 National Vaccine Plan (http://www.hhs. gov/nvpo/vacc_plan/2010 percent20Plan/appendix5.pdf).

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STAKEHOLDER CONCERNS 61 INFORMATION GATHERING After identifying key stakeholders, the committee reviewed the most frequently expressed concerns related to the safety of the immunization schedule from three primary sources of information: the current literature, online postings, and public testimony. The committee reviewed all the information that interest groups, in- dividuals, and researchers provided through the online submissions and in public testimony at the committee meetings and throughout the study pe- riod. Even before the first committee meeting, the committee received online testimony as well as many e-mail messages. The committee held three public meetings that included information-gathering sessions and a session during which it heard public testimony. During the three public meetings, the final hour was reserved for stakeholders to share their concerns related to the committee’s charge. Throughout the study, the committee also reviewed media coverage and scientific articles related to the safety of the immuniza- tion schedule. However, the committee based its review of the safety of the immunization schedule on information reported in the scientific literature. The literature review focused on the recommended childhood immuni- zation schedule and yielded an extensive body of scientific articles, reports in the popular media, reviews, and summaries. Because the committee’s study period was limited (no longer than 12 months), the committee es- tablished priorities to identify and review the most common and notewor- thy stakeholder concerns about the safety of the childhood immunization schedule. LITERATURE SEARCH The committee used the Ovid MEDLINE database to search the scien- tific literature published within the past 10 years (2002 to 2012). Multiple comprehensive searches were used to identify references that described stakeholder concerns and analyzed health outcomes after immunization according to the recommended childhood immunization schedule. The committee focused on articles published in the past 10 years because the childhood immunization schedule has been modified several times as new vaccines have been approved and incorporated into the schedule. Concerns related to the 2001 recommended childhood immunization schedule are likely to be different from concerns related to 2012’s schedule, which rec- ommends additional immunizations for children. Because the committee’s task was to assess the safety of the immunization schedule rather than the safety of individual vaccines, the literature searches did not include articles that focused on a single vaccine. The committee’s review included peer- reviewed publications such as scientific articles, reviews, commentaries,

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62 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY and editorials. The committee used medical subject heading searches to identify references, using the terms “immunization” (which includes “im- munization schedule”), “vaccines,” “attitude to health,” and “attitude of health personnel.” The initial literature search yielded 421 articles. To further refine the search, the committee reviewed the titles and abstracts (when available) and removed articles that met any of following three exclusionary criteria. First, from the beginning of the study period, the committee noted that the child- hood immunization schedule spans the entire period of childhood (birth to age 18 years). The committee found that the most prominent safety con- cerns about the immunization schedule are related to vaccinations received during infancy and early childhood. Thus, the committee focused its review on the body of literature that addressed concerns about the short- and long- term effects of the schedule of vaccinations given to young children (birth to age 6 years) and excluded studies that focused on the immunization schedule for older children and adolescents (age >6 years). Second, the com- mittee excluded studies that focused on individual vaccines or combination immunizations rather than the entire childhood immunization schedule. Finally, the committee excluded studies of non-U.S. populations, unless the study focused on the U.S. Advisory Committee on Immunization Practices (ACIP)–recommended immunization schedule for young children. After the committee applied these criteria, it retained 85 published articles for comprehensive review. Two-thirds of these articles were catego- rized as studies of parental concerns about either safety (n = 26) or commu- nication between providers, public health authorities, and parents (n = 31). Several articles that the committee reviewed did not meet the study criteria (largely owing to having an older publication date) but were frequently cited in the literature and added to the committee’s knowledge base. An iterative review of the literature as well as oral and written public comments revealed that among the primary stakeholders (parents, health care providers, public health officials), a subset of parents were the group with the most concerns about the safety of the immunization schedule. The review also revealed that parents, providers, and public health officials all believe that effective communication about these safety concerns remains a challenge. PARENTAL CONCERNS IN THE SCIENTIFIC LITERATURE Parental concerns about the safety of vaccines and the immunization schedule have been well publicized but are not well understood by all health care professionals. A number of recent studies have described the challenges associated with research into the safety of the immunization schedule and defined the methods that can be used to elicit and quantify parental con-

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STAKEHOLDER CONCERNS 63 cerns (Dempsey et al., 2011; Freed et al., 2010; Gust et al., 2005; Kennedy et al., 2011a; Niederhauser et al., 2001; Salmon et al., 2004). In 2000, Gellin et al. reported that the two most common concerns that parents expressed about childhood immunizations were that too many vaccines were being administered to infants and children and that child- hood vaccines may weaken the immune system (Gellin et al., 2000). The 2002 IOM report Immunization Safety Review: Multiple Immunizations and Immune Dysfunction determined that no biological or epidemiologi- cal evidence for such concerns was available and that infants receive more antigenic exposures from the natural world, including exposures to infec- tions for which no vaccine is provided. The report noted, however, that “the committee concludes that concern about multiple immunizations has been, and could continue to be, of societal significance in terms of parental worries, potential health burdens, and further challenges for immunization policy-making” (IOM, 2002, p. 12) A recent study of the concerns stated by parents with young children (<7 years) in the 2010 HealthStyles survey revealed a number of vaccine- related attitudes and concerns (Kennedy et al., 2011b). The concerns that 376 respondents reported the most frequently are listed in Table 4-1. Similar results were found in the 2002 HealthStyles and Consumer- Styles surveys of a nationally representative sample of 697 parents, al- though the rank order of their concerns was slightly different (Gust et al., 2005). Despite documented parental concerns about vaccines, most parents still have their children receive the recommended immunizations. In fact, the 2010 National Immunization Survey (NIS) reported that less than 1 percent of toddlers had received no vaccines at all (CDC, 2012).  A 2011 article focused on the relationship between parents’ attitudes toward childhood immunizations and the decision to delay or decline immunizations (Smith et al., 2011). Using data from the 2009 NIS, the researchers reviewed 11,206 parents’ reports of immunization delays and refusals. Approximately 60 percent of parents with children aged 24 to 35 months neither delayed nor refused immunizations; 26 percent only delayed TABLE 4-1  Vaccine-Related Concerns, 2010 Vaccine-Related Concern Percentage of Responses It is painful for children to receive so many shots during 38 one doctor’s visit. My child is getting too many vaccines in one doctor’s visit. 36 Children get too many vaccines during the first 2 years of 34 life. SOURCE: Kennedy et al., 2011b.

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64 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY one or more immunizations; 8 percent refused one or more immunizations; and approximately 6 percent both delayed and refused one or more immu- nizations. Concerns were aggregated into categories such as a lack of trust that vaccines are safe, suspicions that vaccines might produce serious side effects, concerns that too many vaccines can overwhelm a child’s immune system, and the general sense that their children are immunized with too many vaccines (Smith et al., 2011). Safety concerns have led some parents to prefer alternative immuniza- tion schedules that may involve delaying specific immunizations or omit- ting some or all immunizations. A recent review of the literature on the growing trend of following alternative immunization schedules produced a summary of parental concerns, such as concerns about vaccine safety, efficacy, and necessity; distrust of vaccine advocates’ motivation; and in- sufficient information with which to make an informed decision (Dempsey et al., 2011). Health care providers reported that parents’ requests for an alternative schedule may be based on a specific immunization schedule or may reflect parental concerns about an individual vaccine rather than the entire schedule. A recent cross-sectional, Internet-based survey of a representative sam- ple of parents of young children (ages 6 months to 6 years) reported that less than 10 percent of parents indicated that they follow an alternative immunization schedule (Dempsey et al., 2011). The study identified the four vaccines that were the most commonly refused: the H1N1 influenza, sea- sonal influenza, rotavirus, and varicella vaccines. In general, newer vaccines were more likely to be declined than were established vaccines. Parents who requested a delay for a specific vaccine most commonly (more than 40 percent) requested a delay in receiving MMR and the varicella vaccine. In 2009, Freed et al. conducted an online survey and reported that the varicella and meningococcal vaccines were the most commonly refused (Freed et al., 2009). An analysis of responses to the NIS in 2003 and 2004 also reported that the varicella vaccine was the one that prompted the most concerns among parents who declined immunizations for their children (Gust et al., 2008). Although parents have various reasons for declining or delaying im- munizations, a 2011 study also reported that a large proportion of parents who requested an alternative immunization schedule understood and ac- knowledged that undervaccination increases the risk of infection and spread of disease in the community (Dempsey et al., 2011). Despite recent increases in the popularity of alternative immunization schedules, their use remains infrequent (Dempsey et al., 2011; Robison et al., 2012). Analysis of the data from the 2003-2004 NIS revealed that parents of underimmunized children articulated their concerns about the safety of the immunization schedule in the popular media more forcefully than did

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STAKEHOLDER CONCERNS 65 parents of fully immunized children (Gust et al., 2004). Results of a later iteration of the 2009 NIS found that parents of fully immunized children reported concerns about vaccines, but their concerns did not preclude im- munization of their children (Kennedy et al., 2011a). In their public testimony during the committee meetings, parents pro- vided a range of concerns about the immunization schedule; the committee received limited public testimony from parents who endorse the recom- mended schedule, despite evidence that the majority of U.S. parents support and follow ACIP’s recommendations (CDC, 2012). The 2004 NIS reported that parental concerns about vaccine safety were associated with underimmunization, which is further associated with adverse health outcomes for individuals and their communities, including increases in the prevalence of vaccine-preventable diseases (Gust et al., 2004). Furthermore, the designs used in most studies of immunizations do not permit a detailed analysis of the impact of parental concerns on parents’ decision to immunize their children (Kennedy et al., 2011b). And, although many research studies have focused on parental concerns about vaccine safety, they have not adequately explored parental knowledge of the protective benefits of immunizations. The committee identified a need for further study of parental attitudes and concerns about immunization. Based on the committee’s review of the literature and public testimony, the committee strongly endorses research to understand parents’ knowledge, beliefs, and concerns about vaccines and vaccine-preventable diseases, which is a key component of the 2010 National Vaccine Plan. PUBLIC CONCERNS PRESENTED TO THE COMMITTEE The public testimony presented to the committee highlighted concerns about the quality and strength of existing research on vaccine safety in the United States. Some individuals who provided public testimony focused on the lack of research on vaccine safety for subpopulations that may be potentially susceptible to adverse events. For example, children with fam- ily histories of adverse vaccine events, autoimmune diseases, allergies, and neurological diseases were described to be underrepresented in prelicensure and clinical trials of childhood immunizations. Furthermore, public testimony to the committee described the specula- tion that children with a family history of autoimmune disease or allergies and premature infants may be additional subpopulations at increased risk for adverse effects from immunizations. The 2012 IOM report Adverse Ef- fects of Vaccines: Evidence and Causality supports the fact that individuals with certain characteristics (such as acquired or genetic immunodeficiency)

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66 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY are more likely to suffer adverse effects from particular immunizations, such as MMR and the varicella vaccine (IOM, 2012). During each of the three public sessions held in conjunction with com- mittee meetings, the testimony of many individuals and organizational representatives revealed a lack of trust in the quality and thoroughness of vaccine safety research. Several individuals recommended that the commit- tee review the scientific studies that have compared health outcomes among fully vaccinated, partially vaccinated, and unvaccinated children as well as children who have been vaccinated according to alternative schedules. The comments that were submitted through an online questionnaire in response to the committee’s commissioned paper (see Appendix D) echoed many of the concerns and suggestions that were articulated during the three public sessions. The sentiments largely focused on the concern that the recommended immunization schedule bombards children’s immune systems with an excessive number of antigens at an early age and may not be as safe as possible. PATIENT-PROVIDER COMMUNICATION As indicated by the high rates of vaccination coverage, most Ameri- can parents believe that vaccinations are an effective way to protect their children from serious infectious diseases (CDC, 2012). Despite this strong support, parents have concerns, questions, and misperceptions about child- hood immunizations (Kennedy et al., 2011b). Parents seek information about vaccine safety from a multitude of sources: public health authorities, pediatricians, other child health care professionals, professional organiza- tions’ websites, personal blogs, celebrities, and advocacy groups (Freed et al., 2011). With such a wide range of sources of information about immuniza- tions, the committee recognized the likelihood that parents could receive conflicting information that could exacerbate their concerns and confusion about the safety of vaccines. The committee also noted the many high- quality websites and materials that have recently been produced, includ- ing Vaccines.gov and materials produced by the American Academy of Pediatrics (AAP) and available on the AAP website. However, findings from an online survey conducted as part of an ongoing study of 2,521 parents and nonparents demonstrated that although websites from doctors’ groups, such as AAP, and government websites were trusted by the greatest proportion of surveyed parents (27 and 7 percent, respectively), a larger proportion did not view or use these resources at all (29 and 38 percent, respectively) (Freed et al., 2011). Apart from the confusion associated with conflicting sources of in- formation about childhood vaccines (Freed et al., 2011), the committee’s

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STAKEHOLDER CONCERNS 67 review of the scientific literature and the public testimony identified the lack of parental trust in vaccines and vaccine safety to be an important concern. Overall, a large majority of parents rely on the professional advice they receive from their child’s doctor or health care provider, and they report high levels of trust in their doctor’s advice (Freed et al., 2011). However, a recent study reported that 26 percent of parents trusted celebrities as a reliable source of information on the safety of vaccines (Freed et al., 2011). Thus, although the relationship between the parent and the child’s health care provider is a strong determinant of decision making about childhood vaccines, some parents rely on nonprofessional sources of information to make the same decisions (Gust et al., 2008; Serpell and Green, 2006). In some cases, pediatricians may dismiss parents from their practice if the parents decline vaccines, delay vaccinations, or base their decisions on unscientific information (Flanagan-Klygis et al., 2005). For example, a 2011 study reported that more than 30 percent of Connecticut pediatricians have dismissed families because of their refusal to immunize their children (Leib et al., 2011). AAP discourages the dismissal of parents on the basis of their refusal to immunize their children (Diekema and the AAP Committee on Bioethics, 2005). Furthermore, AAP believes that providers should main- tain a relationship with families that decline immunizations so that children continue to receive appropriate medical care. In addition to the value of that care, the continuing relationship provides an opportunity for the pe- diatrician to encourage parents to consider immunization of their children in the future (Diekema and the AAP Committee on Bioethics, 2005). The committee also notes that the dismissal of families from pediatric practices could further erode trust in the health care system. A recent study of 209 pediatricians in Washington State reported that parental requests for alternative immunization schedules are not uncom- mon (Wightman et al., 2011). Overall, 61 percent of these pediatricians agreed that they were comfortable using different schedules if the parents made this request. The three vaccines that most pediatricians were willing to delay were the hepatitis B vaccine (69 percent), varicella vaccine (53 percent), and inactivated poliovirus vaccine (45 percent) (Wightman et al., 2011). Based on the literature review and public testimony, the committee noted the importance of providers’ knowledge of vaccine safety. Further- more, the committee found it to be essential that providers use a communi- cation style that elicits parents’ concerns and encourages respectful dialogue to address divergent opinions. Even though health care providers may focus on the benefits of childhood immunizations, they may not adequately dis- cuss the anticipated, higher-prevalence side effects or the potential events that are significantly more rare and severe. Therefore, based on the review of the scientific literature and the public input, the committee believes that

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68 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY all health care providers who immunize children should receive training in communication with the goal of improving provider-parent communication of immunization issues (Gust et al., 2008a). Apart from the need for training in communication, the committee reviewed several recent studies that identified the need for improved com- munication about vaccine safety by the scientific community and public media (Gust et al., 2006, 2008b; Levi, 2007). Gust et al. (2006) suggested that enhanced communication training for providers should increase their willingness to engage parents in discussions of vaccine and immunization issues. Studies are also under way to develop techniques to identify categories of vaccine hesitancy and develop tools to assist providers as they commu- nicate with parents who express concerns about vaccines (Diekema, 2012). The 2002 IOM report Immunization Safety Review: Multiple Immuniza- tions and Immune Dysfunction recommended that an appropriate panel of multidisciplinary experts be convened to “develop a comprehensive re- search strategy for knowledge leading to the optimal design and evaluation of vaccine risk-benefit communication approaches” (IOM, 2002, p. 16). Furthermore, the 2010 IOM study described in the report Priorities for the National Vaccine Plan emphasized that communication must reflect current research and strategies (IOM, 2010). Government agencies and professional organizations play a key role in providing parents with information on vaccines and immunizations. How- ever, the public erosion of trust in government and the suboptimal effective- ness of public health campaigns on immunizations in particular highlight the challenges of mounting an effective strategy of communication about the childhood immunization schedule. This challenge is exacerbated by the fact that public decision making as it applies to vaccines is driven not only by scientific and economic evidence but also by political, psychological, and sociocultural factors. CONCLUSIONS From the literature review and the comments received online and dur- ing the public sessions, the committee determined that although the major- ity of parents adhere to the ACIP-recommended immunization schedule for their children, many parents remain concerned that their children may face unnecessary risks because of the timing and number of vaccinations. The decisions that parents make about the risk of disease versus the risk of immunization are attributable, in part, to the significant and sus- tained declines in most vaccine-preventable diseases that have resulted in the community immunity (also known as herd immunity) that vaccination policy has achieved. Although some parents may not fully understand the

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STAKEHOLDER CONCERNS 69 concept of community immunity, at some level, many parents understand that widespread efforts to immunize children protect both vaccinated and unvaccinated children. The protection offered by community immunity may mislead some parents who decline all immunizations and allow them to believe that childhood vaccines are unnecessary, when vaccination in the community has actually shielded their children from serious infectious diseases (Chen et al., 2005). Finally, some parents are concerned about their child’s risk of complications of immunization with a vaccine on the basis of family history or the child’s medical conditions, and, decide to delay or omit immunizations. Children with certain predispositions are more likely to suffer adverse events from vaccines than are those without that risk factor, such as children with immunodeficiencies who are at increased risk for developing invasive disease from a live virus vaccine (IOM, 2012). The committee recognizes that while the CDC has identified persons who should not be vaccinated because of certain symptoms or conditions, some stakeholders question if that list is complete. Potentially susceptible popula- tions may have an inherited or genetic susceptibility to adverse reactions, and further research in this area is ongoing. Thus, the committee understands that parental concerns are an ex- pression of concern over and a way to care for their children’s health and well-being. However, the committee also recognizes that a growing pattern of delaying or declining all or some vaccines has already contributed to outbreaks of vaccine-preventable diseases and mortality across the United States. These disease outbreaks place children and adults at risk, including children who are only partially immunized or experience waning immunity. Immunized children and adults in the community represent another group of stakeholders, and the committee recognizes the concern about declining community immunity as well. Research from telephone surveys and other methods reviewed in this chapter typically provide information about what participants think, but such surveys usually cannot probe into why respondents think the way they do. To develop an effective risk-benefit communication strategy, more detailed research is warranted. The committee concludes that parents and health care professionals would benefit from the availability of more com- prehensive and detailed information with which to address parental con- cerns about the safety of the vaccines in the immunization schedule. Such information should clearly address vaccine-preventable diseases, the risks and benefits of immunizations, and the safety of the vaccines in the im- munization schedule. At present, as described in Chapter 5, relatively few studies have di- rectly assessed the immunization schedule. Although health care profession- als have a great deal of information about individual vaccines, they have much less information about the effects of immunization with multiple

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70 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY vaccines at a single visit or the timing of the immunizations. Providers are encouraged to explain to parents how each new vaccine is extensively tested when it is approved for inclusion in the recommended immunization sched- ule. However, when providers are asked if the entire immunization schedule has been tested to determine if it is the best possible schedule, meaning that it offers the most benefits and the fewest risks, they have very few data on which to base their response. Furthermore, although the 2010 National Vaccine Plan addresses the need to provide health care providers with more timely, accurate, and transparent information about the benefits and risks of vaccines, providers are not singled out in specific strategies offered by the U.S. Department of Health and Human Services. Although the committee identified several studies that reviewed the outcomes of studies of cumulative immunizations, adjuvants, and preserva- tives (see Chapter 5), the committee generally found a paucity of informa- tion, scientific or otherwise, that addressed the risk of adverse events in association with the complete recommended immunization schedule, even though an extensive literature base about individual vaccines and combi- nation immunizations exists. The committee also acknowledges that the public health community has in place monitoring systems that work very well for the detection of adverse events that occur in the short term after immunization and that could be enhanced for the detection of longer-term outcomes, as discussed in Chapters 3 and 6. The continuation of studies looking at immune phenotyping, such as those of the National Institutes of Health’s Human Immunology Project Consortium, is also important in the identification of populations that are potentially susceptible to adverse events (HIPC, 2012). To achieve the goal of giving health care providers and parents informa- tion that addresses the concerns that correlate with delaying or declining childhood immunizations, the committee developed a list of priority areas in which more information or clear communication of existing research is needed. The committee summarizes the priority concerns into the follow- ing topics: 1. Immune system overload. As several parents asked, are children given too many vaccines? Do immunizations start when babies are too young? Are immunizations administered too frequently? 2. Immunization schedule. What is the evidence that the ACIP-­ recommended immunization schedule is better than other sched- ules? Could the health outcomes among children who are vaccinated according to the recommended schedule be compared with those among unimmunized children? Likewise, could the health out- comes among children vaccinated on the recommended schedule

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STAKEHOLDER CONCERNS 71 be compared with those among children vaccinated on alternative schedules? 3. Are subpopulations of children potentially susceptible to adverse reactions to vaccines, such as children with a family history of autoimmune disease or allergies or children born prematurely? The committee recognizes not only that additional information is needed to address parental concerns but also that other factors will affect parental decision making. For example, in the testimony and online com- ments, the committee identified skepticism about (1) the quality of vaccine research (prelicensure and postmarketing), (2) the influence of pharmaceu- tical companies on scientific research, and (3) the influence of the govern- mental entities that oversee vaccine research. In addition, as stated earlier, clear and effective parent-provider communication is essential to convey accurate information and foster mutual trust. The committee’s review of the determinants of public trust in vac- cination campaigns and information on vaccines identified three types of concerns raised by stakeholders: • knowledge and expertise, • openness and honesty, and • concern and care. Thus, improved communication between public health authorities and parents requires improvements to the clarity of the information and the effectiveness with which the information is conveyed, as well as the build- ing of trust and the use of a systematic approach to elicit public concerns. Further research into the impact of parental perceptions about risk on their decisions about immunizing their children is indicated, and that re- search should be performed by methods that use decision and social science (Larson et al., 2011). The committee acknowledges that parents and providers are not the only stakeholders who are concerned about the safety of the immuni- zation schedule. The committee listened to presentations from a range of stakeholders whose concerns focused on providing immunizations to preserve community immunity and to prevent the reemergence of vaccine- preventable diseases, which ultimately requires the cooperation and trust of parents in immunizing their children. These other groups and individuals who also have a vested interest in providing children with a safe and ef- fective immunization schedule include pharmaceutical companies; federal, state, and local governments; health insurers; the many health care provid- ers who oversee administration of vaccines; and many others in the health care system.

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72 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY The committee also acknowledges that the low rate of many infectious diseases may encourage parents to focus on the risks of immunizations rather than the risk of vaccine-preventable diseases. These low rates of infectious diseases may reinforce parents’ reliance on community immunity to protect their child rather than choose immunizations. The vaccine safety activities of the federal government are prioritiz- ing the engagement of stakeholders in multiple activities, detailed in the 2010 National Vaccine Plan and implementation efforts, as well as the Scientific Agenda of the Centers for Disease Control and Prevention’s Im- munization Safety Office. However, an effective national vaccine program will require better-quality information on stakeholder concerns about the safety of vaccines, the severity of vaccine-preventable diseases, individual and population-level immunization, vaccine efficacy, and the delivery and supply of vaccines recommended in the childhood immunization schedule. To effectively implement immunization programs, a state-of-the-art com- munication plan is needed. Recommendation 4-1: The committee recommends that the National Vaccine Program Office systematically collect and assess evidence re- garding public confidence in and concerns about the entire childhood immunization schedule, with the goal to improve communication with health care professionals, and between health care professionals and the public regarding the safety of the schedule. REFERENCES Brown, K.F., S.J. Long, M. Ramsay, M.J. Hudson, J. Green, C.A. Vincent, J.S. Kroll, G. Fraser, and N. Sevdalis. 2012. U.K. parents’ decision-making about measles-mumps-rubella (MMR) vaccine 10 years after the MMR-autism controversy: A qualitative analysis. Vaccine 30(10):1855-1864. CDC (Centers for Disease Control and Prevention). 2012. National, state, and local area vac- cination coverage among children aged 19-35 months—United States, 2011. MMWR Morbidity and Mortality Weekly Reports 61(35):689-696. Chen, R.T., R.L. Davis, and P.H. Rhodes. 2005. Special methodological issues in pharmaco- epidemiology studies of vaccine safety. In Pharmacoepidemiology, vol. 4, edited by B.L. Strom. West Sussex, England: John Wiley & Sons, Ltd. Pp. 455-485. Dempsey, A.F., S. Schaffer, D. Singer, A. Butchart, M. Davis, and G.L. Freed. 2011. Alter- native vaccination schedule preferences among parents of young children. Pediatrics 128(5):848-856. Diekema, D.S. 2012. Issues leading to vaccine hesitancy. Presentation to Meeting 2 of the Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule, Seattle, WA, March 8. Diekema, D.S., and the AAP Committee on Bioethics. 2005. Responding to parental refusals of immunization of children. Pediatrics 115(5):1428-1431.

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