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Informed Consent to Vaccination: Theoretical, Legal, and Empirical Insights

Published online by Cambridge University Press:  06 January 2021

Dorit Rubinstein Reiss
Affiliation:
UC Hastings College of Law.
Nili Karako-Eyal
Affiliation:
School of Law, the College of Management, Academic Studies, Israel

Abstract

Informed consent matters — so does protecting people from infectious diseases. This paper examines what the appropriate informed consent process for vaccines should look like and how the process is conceptualized by law and health authorities. Drawing on the extensive theoretical and empirical literature on informed consent and vaccination, this article sets out what an ideal informed consent process for vaccination would consist of, highlighting the need for autonomous decisions. To be autonomous, decisions need to be based on full, accessible information and reached without coercion. We suggest that the information provided must address the nature of the procedure — including benefits to the child, benefits to society, and risks. Parents should have their concerns and misconceptions addressed. The information needs to be accessible and include an opportunity to ask questions. Based on this ideal model we examined in detail the legal framework surrounding informed consent to vaccination and the process as conceptualized by health authorities in two countries, Israel and the United States, to assess whether they meet the requirements. These two countries are similar in some of their values, for example, the importance of individual autonomy, and face similar problems related to vaccine hesitancy. At the same time, there are meaningful differences in their vaccine policies and the current structures of their informed consent processes, allowing for a meaningful comparison. We found neither country met our ideal informed consent process, and suggested improvements both to the materials and to the processes used to obtain informed consent.

Type
Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2019

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32 In Israel, the 1995 National Health Insurance (NHI) Law guarantees universal health insurance coverage to all citizens and permanent residents. In the United States, citizens receive healthcare through a complex public-private marketplace. For an extensive and elaborated description of the differences between the countries, see Bruce Rosen & Keith Kanel, Healthcare in the US and Israel: A Comparative Overview (Halsted ed., 2010), http://www.prhi.org/resources/resources-article/archives/monographs/86-monographs-1-healthcare-in-the-u-s-and-israel/file [https://perma.cc/7XK9-GJRR].

33 See Vaccination Programs, Ctrs. for Disease Control and Prevention (July 12, 2017), https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/programs.html [https://perma.cc/9LPU-AJS7]; Vaccines for Babies and Children, Isr. Ministry of Health, https://www.health.gov.il/English/Topics/Pregnancy/Vaccination_of_infants/Pages/default.aspx [https://perma.cc/3958-LP6H]; see also Philip J. Smith et al., Underinsurance and Pediatric Immunization Delivery in the United States, 124 Pediatrics S507, S511–S513 (2009).

34 For differences in vaccination delivery and requirements, compare Vaccination Programs, Ctrs. for Disease Control and Prevention, supra note 33, with Vaccines for Babies and Children, Isr. Ministry of Health, supra note 33.

35 For a paper discussing this issue, see Dorit Rubinstein Reiss, Rights of the Unvaccinated Child, 73 Studies in Law, Politics, & Society 73 (2017).

36 For the relationship between informed consent and school mandates in the United States, see infra text accompanying footnotes 291–331.

37 Sheila A. M. Mclean, Autonomy, Consent and the Law 40–41 (2009); see also Ruth R. Faden & Tom L. Beauchamp, A History and Theory of Informed Consent 54 (1986); Alasdair Maclean, Autonomy, Informed Consent and Medical Law: A Relational Challenge 144 (2009).

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45 Kochuba, supra note 7, at 765; see also Nuffield Council on Bioethics, Public Health: Ethical Issues 54 (2007), http://nuffieldbioethics.org/wp-content/uploads/2014/07/Public-health-ethical-issues.pdf [https://perma.cc/B2HN-7W98]. There may be various reasons why some children have not been or cannot be vaccinated. Some children cannot receive the vaccine for medical reasons. Other children have not reached the age at which vaccination would be recommended. There are children who were not vaccinated because they lack access to health services or their parents have refused the vaccine. Other children may not have the required immunity although vaccinated. For example, children who did not complete the recommended childhood immunization schedule and individuals who did not develop protective responses to vaccines (vaccine failure). These individuals depend on herd immunity for protection from the disease. Id.

46 See generally Terry C. Davis et al., Childhood Vaccine Risk/Benefit Communication in Private Practice Office Settings: A National Survey, 107 Pediatrics 1, 3–5, 8 (2001); Kaliner, et al., Silent Reintroduction of Wild-Type Polioviruses to Israel, 2013 – Risk Communication Challenges in an Argumentative Atmosphere, 19 Eurosurveillance 1, 3 (2014)CrossRefGoogle Scholar; Woolley, supra note 7, at 1302.

47 Davis, supra note 46, at 1, 5.

48 Gillett & Walker, supra note 40.

49 Gostin & Wiley, supra note 44.

50 John Stuart Mill, On Liberty 8 (Martino Pub. 2009) (1869).

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61 Steve, P. Calandrillo, Vanishing Vaccinations: Why Are So Many Americans Opting Out of Vaccinating Their Children?, 37 U. Mich. J. L. Reform 353, 395-96, 400-401(2004)Google Scholar.

62 See Gesser-Edelsburg et al., General Good vs. Individual Risk, supra note 16, at 406 (discussing generally the informational uncertainty and ambiguity associated with a decreased willingness to adopt preventive measures, such as vaccinations).

63 Am. Acad. of Pediatrics, supra note 59; Greenberg et al., supra note 53, at 2-3.

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67 Community Preventive Services Task Force, Increasing Appropriate Vaccination: Clinic-Based Client Education When Used Alone (2011) 3-4, https://www.thecommunityguide.org/sites/default/files/Vaccination-Clinic-based-Education-Archive.pdf [https://perma.cc/7HXQ-A498]; see also De La Torre-Fennell, supra note 7, at 724; Horne et al., supra note 66, at 10321; Caitlin, Jarrett et al., Strategies for Addressing Vaccine Hesitancy – A Systematic Review, 33 Vaccine 4180, 4184 (2015)Google Scholar; Inmaculada, de Melo-Martín, The Promise of the Human Papillomavirus Vaccine Does Not Confer Immunity Against Ethical Reflection, 11 The Oncologist 393, 395 (2006)Google Scholar; Williams, supra note 53, at 2589, 2594.

68 Schumacher, supra note 7, at 118 and text accompanying note 128; Severyn, supra note 7, at 271.

69 Community Preventive Services Task Force, supra note 67, at 3-4; see also Sadaf, A. et al., A Systematic Review of Interventions for Reducing Parental Vaccine Refusal and Vaccine Hesitancy, 31 Vaccine 4293, 4301 (2013)CrossRefGoogle ScholarPubMed; Corben & Leask, supra note 58, at 3171-72; Eve Dubé et al., Strategies Intended to Address Vaccine Hesitancy: Review of Published Reviews, 33 Vaccine 4191, 4192, 4200 (2015).

70 Corben & Leask, supra note 58, at 3171; Brendan Nyhan et al., Effective Messages in Vaccine Promotion: A Randomized Trial, 133 Pediatrics e835, e841, e842 (2014); Williams, supra note 53, 2585.

71 Nyhan et al., supra note 70, at e835.

72 Id.

73 Williams, supra note 53, at 2585, 2588. Tailored interventions are people-centered interventions, built on the approach that the intended beneficiaries should be listened to and the wide range of factors influencing vaccination uptake should be acknowledged and considered in the programing of a vaccination communication strategy. These include not only individual motivation, attitudes and beliefs, but to a high degree social, community and cultural factors as well as legislative, institutional and structural factors. A non-tailored intervention is a “one-size fits all” approach to immunization communication strategy. See Eve Dubé et al., The WHO Tailoring Immunization Programs (TIP) Approach: Review of Implementation to Date, 36 Vaccine 1509, 1510 (2018).

74 Horne et al., supra note 66, at 10324. However, it should also be noted that other studies found mixed effects of loss framed messages and fear appeals on vaccination and other preventive health behaviors. Nyhan et al., supra note 70, at e840.

75 Jarrett et al., supra note 67; Williams, supra note 53, 2589.

76 Corben & Leask, supra note 58, at 3172.

77 For a similar claim, see Kumar et al., supra note 43, at 6.

78 For a similar claim, see Corben & Leask, supra note 58, at 3171-72.

79 For a similar claim, see Hardt et al., supra note 53, at 213.

80 Dubé et al., supra note 69, at 4191, 4201. For a review of the different interventions used to address vaccine hesitancy, see id. at 4193-99.

81 Id. at 4199.

82 World Health Org., Vaccination and Trust: How Concerns Arise and the Role of Communication in Mitigating Crises 25 (2017), http://www.euro.who.int/__data/assets/pdf_file/0004/329647/Vaccines-and-trust.PDF [https://perma.cc/H6JN-3Q7T]. See also Parmet, supra note 4, at 97-98; Williams, supra note 53, 2585.

83 Glen, J. Nowaka & Michael, A. Cacciatore, Parents' Confidence in Recommended Childhood Vaccinations: Extending the Assessment, Expanding the Context, 13 Hum. Vaccines & Immunotherapeutics 687, 687–88 (2017)Google Scholar; Sachiko Ozawa et al., Exploring Pathways for Building Trust in Vaccination and Strengthening Health System Resilience, 16(Suppl 7):639 BMC Health Serv. Res. 131, 132 (2016).

84 Eur. Ctr. for Disease Prevention and Control, Communication on Immunisation – Building Trust at 5 (2012), https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/TER-Immunisation-and-trust.pdf [https://perma.cc/R8RD-ZE9A]; see also Ozawa et al., supra note 83, at 136.

85 Ames et al., supra note 59, at 20; Kumar et al., supra note 43, at 2; Hardt et al., supra note 53, at 206; Petrelli et al., supra note 66, at 90-91; Williams, supra note 53, 2585.

86 Greenberg et al., supra note 44, at 9-10; Williams, supra note 53, 2585.

87 World Health Org., Report of the Sage Working Group on Vaccine Hesitancy 9 (2014), http://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf [https://perma.cc/32ZC-J3Z3] [hereinafter World Health Org., Report].

88 Id.; see also Nowaka & Cacciatore, supra note 83, at 687.

89 Ozawa et al., supra note 83, at 136; see also World Health Org., Report, supra note 82.

90 World Health Org., Report, supra note 82

91 Eur. Ctr for Disease Prevention and Control, Communication on Immunisation, supra note 84.

92 Id.

93 Id.

94 For a similar claim, see Thomas, May, Public Communication, Risk Perception, and the Viability of Preventive Vaccination Against Communicable Diseases, 19 Bioethics 407, 418–419 (2005)Google Scholar; see also Marloes Bults et al., Perceived Risk, Anxiety, and Behavioral Responses of the General Public During the Early Phase of the Influenza A (H1N1) Pandemic in the Netherlands: Results of Three Consecutive Online Surveys, BMC Pub. Health (Jan. 3, 2011), http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-11-2 [https://perma.cc/J3PF-36MZ].

95 World Health Org., Vaccination and Trust supra note 82, at 25.

96 Eur. Ctr for Disease Prevention and Control, Communication on Immunisation, supra note 84, at 5.

97 For similar claims, see Karin Hardt et al., supra note 53, at 213; Parmet, supra note 1, at 97-98.

98 See generally Faden, supra note 37; Rebecca L. Walker, Medical Ethics Needs a New View of Autonomy., 33 J. Med. and Phil. 594, 595 (2008).

99 Faden, supra note 37, at 123. All or part of these conditions were mentioned by other scholars as well. See, e.g., Tom. L. Beauchamp & James F. Childress, Principles of Biomedical Ethics 124 (2013); H. Tristram Engelhardt Jr., The Foundation of Bioethics 306, 308 (1996); Irene S. Switankowsky, A new Paradigm For Informed Consent 11 (1998).

100 For the definition of an intentional act, see Faden, supra note 37, at 256–57.

101 See supra notes 66-81 and accompanying text.

102 Faden, supra note 37, at 250, 252.

103 Id.

104 Id.

105 Id. at 255. Faden and Beauchamp acknowledge that complete understanding is not possible. Therefore, to allow decisions to be autonomous, they were satisfied with a substantive understanding of the information. Id. at 238–49, 289.

106 For a discussion regarding public trust in health authorities, see supra text accompanying notes 13-15.

107 An example for informational formatting that is not expected to result in misconceptions, would be the provision of accurate information to parents about the proposed vaccine without mentioning the myths associated with it.

108 See Tom, L. Beauchamp, Informed Consent: Its History, Meaning, and Present Challenges, 20 Cambridge Q. Healthcare Ethics 515, 515–16, 518-19 (2011)Google Scholar; Maclean, supra note 37, at 134–36; Mclean, supra note 37, at 42-3.

109 For the claim that in deciding what information should be provided to parents', the personal characteristics of the parents should be considered, see Hardt et al., supra note 53, at 213.

110 See also World Health Org., Vaccination and Trust, supra note 82, at 32; Dubé et al., supra note 69, at 4201.

111 As is apparent from the model proposed above, this list is not exclusive. The content of information provided to parents should be adapted according to their special informational needs. See generally Eur. Ctr. for Disease Prevention and Control, Rapid Literature Review on Motivating Hesitant Population Groups in Europe to Vaccinate 7 (2015), https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/vaccination-motivating-hesistant-populations-europe-literature-review.pdf [https://perma.cc/UZ4P-VXZR].

112 See Woolley, supra note 7, at 1307, for the claim that parents should be informed of alternative vaccines. The writer rightly claims that the duty to disclose such information to parents is limited to cases in which the risks and benefits of the alternative vaccine are significantly different from those of the vaccine being considered. Id.

113 See supra text accompanying notes 67-81.

114 See also Parmet, supra note 1, at 100; Woolley, supra note 7, at 1311.

115 This approach differs from the one applied to curative medical treatments, both in the U.S and Israel, according to which patients should not be informed of rare and far-reaching risks. Underlying this approach is the fear that providing patients such information will cause them unnecessary anxiety and flood them with more information than they can reasonably process, endangering their ability to make informed decisions. We believe that these arguments don't apply to vaccination. First, the number of risks, common or rare, involved in vaccination is small. Hence, the fear that parents will be flooded with information is less relevant. Second, providing accurate and clear information about the rarity of the risks involved in vaccination is likely to reduce parent's anxiety. Third, the negative effects involved in providing such information to parents are a reasonable cost considering the possible costs involved in concealing such information from parents: lost of trust in health authorities.

116 See Parmet, supra note 1, at 107.

117 World Health Organization, Vaccination and Trust, supra note 82, at 1; Zhou, Fangjun et al., Economic Evaluation of the Routine Childhood Immunization Program in the United States, 2009, 133 Pediatrics 577, 582-583 (2014)CrossRefGoogle ScholarPubMed

118 Parmet, supra note 1, at 109-110.

119 See Kristin, S. Hendrix et al., Vaccine Message Framing and Parents' Intent to Immunize Their Infants For MMR, 134 Pediatrics at e675, e680 (2014)Google Scholar.

120 Meng Li et al., Stimulating Influenza Vaccination via Prosocial Motives, 11 PLoS One, July 26, 2016, at 2, 10.

121 Id.

122 See Rachel Casiday, Risk and Trust in Vaccine Decision Making, 13 Durham Anthropology J., no. 1, 2005, at 5.9–5.10; Dubé et al., supra note 69, at 1770; Kristin S. Hendrix et al., Vaccine Message Framing and Parents' Intent to Immunize Their Infants For MMR, 134 Pediatrics at e675, e680 (2014); Leask et al., supra note 64, at 7243; Li, supra note 120, at 1, 2, 10; Maheen Quadri-Sheriff et al, The Role of Herd Immunity in Parents' Decision to Vaccinate Children: A Systematic Review, 130 Pediatrics 522, 528-29 (2012).

123 See Parmet, supra note 1, at 109-11.

124 See Karako-Eyal, The Right for Autonomy, supra note 30, at 953.

125 Nuffield Council on Bioethics, supra note 45, at 54.

126 Once herd immunity occurs, the additional benefit to the child from being vaccinated is very small because even if not vaccinated, he would likely be protected from the disease through herd immunity. See Nuffield Council on Bioethics, supra note 45, at 56.

127 Cornelia, Betsch et al., Inviting Free-Riders or Appealing to Prosocial Behavior? Game-Theoretical Reflections on Communicating Herd Immunity in Vaccine Advocacy, 32 Health Psychol. 978, 983 (2013)Google Scholar.

128 See, e.g., Nuffield Council on Bioethics, supra note 45, at 61-62.

129 Id. at 62-63.

130 Id.

131 Several outbreaks in the United States were the result of an unvaccinated child traveling abroad and returning infected with measles. See, e.g., Amy, A. Parker et al., Implications of a 2005 Measles Outbreak in Indiana for Sustained Elimination of Measles in the United States, 355 New Eng. J. Med. 447 (2006)Google Scholar; David E. Sugerman et al., Measles Outbreak in a Highly Vaccinated Population, San Diego, 2008: Role of the Intentionally Undervaccinated, 125 Pediatrics 747 (2010).

132 See Woolley, supra note 7, at 1310.

133 See John Coggon and José Miola, Autonomy, Liberty, and Medical Decision-Making, 70 Cambridge L. J. 523, 530 (2011); Robert McMurray et al., Managing Controversy through Consultation: a Qualitative Study of Communication and Trust around MMR Vaccination Decisions, 54 British J. Gen. Prac. 520, 524 (2004).

134 Victor, Ali, Consent Forms as Part of the Informed Consent Process: Moving Away from “Medical Miranda”, 54 Hastings L. J. 1575, 1586 (2003)Google Scholar.

135 Beatrice Perrenoud et al., The Effectiveness of Health Literacy Interventions on the Informed Consent Process of Health Care Users: A Systematic Review Protocol, 13 JBI Database Systematic Revs. & Implementation Rep. 82, 83 (2015).

136 Yael Schenker et al., Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review, 31 Med. Decision Making 151, 167 (2011).

137 Readability is a quality that reflects how easy texts are to read for a particular individual. Miraida Morales & Sarah Barriage, Readability of Informed Consent Forms: Analysis and Recommendations for Development of Consent Forms for Use with Early and Beginning Readers (2016), https://journals.library.ualberta.ca/ojs.cais-acsi.ca/index.php/cais-asci/article/view/945/843 [https://perma.cc/M9GC-H2WY].

138 Id.

139 Id.

140 Jeanne McGee, McGee & Evers Consulting, Inc., Part 3: Summary List of the “Toolkit Guidelines for Writing and Design,” in Toolkit for Making Written Material Clear and Effective (Sept. 2010), https://www.cms.gov/Outreach-and-Education/Outreach/WrittenMaterialsToolkit/Downloads/ToolkitPart03.pdf [https://perma.cc/7F88-BGKT] [hereinafter CMS Toolkit Part 3], at 7-8; Consent for CDC Research: A Reference for Developing Consent Forms and Oral Scripts, Ctrs. for Disease Control and Prevention (Nov. 1998), https://stacks.cdc.gov/view/cdc/12420 [https://perma.cc/Q3F5-GPEK], at 8-10; see also Kristie B. Hadden et al., Improving Readability of Informed Consents for Research at an Academic Medical Institution, 1 J. Clin. Transl. Sci. 361, 363 (2017); Morales & Barriage, supra note 137; Kim M. Wittenberg & Howard B. Dickler, Creating Informed Consent Documents That Inform: A Literature Review (Feb. 2007), reprinted in Div. of Biomedical and Health Scis. Research, Ass'n of Am. Med. Colls., Universal Use of Short and Readable Informed Consent Documents: How Do We Get There? (May 30, 2007), https://www.aamc.org/download/75282/data/hdicklermtgsumrpt53007.pdf [https://perma.cc/86WR-EP2W].

141 CMS Toolkit Part 3, supra note 140, at 7-8.

142 Attempts at improving readability of informed consent forms often focus on decreasing the length of the forms. Although some studies suggest that decreasing consent form length may improve understanding, not all studies found improvement. See Leanne Stunkel et al., Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form, 32(4) IRB 1, 4-5 (2010); Wittenberg & Dickler, supra note 140, at 15-16. Moreover, some even found that that shortening sentences and using words with fewer syllables to improve readability often ends up causing more confusion and misunderstanding. See Ali, supra note 134, at 1587-88. It follows that less concern should be given to the length of the consent than its ability to be read and understood. The drafters of informed consent forms should therefore strive to balance between the need not to overload parents with excessive information and the need to provide them information in a clear manner, which at times requires the provision of more explanation. For more on this approach, see CMS Toolkit Part 3, supra note 140, at 8.

143 CMS Toolkit Part 3, supra note 140, at 8-9.

144 Id. at 9-10.

145 There are several dozen readability formulas, including the Fry formula, SMOG, and Flesch tests (Flesch-Kincaid and Flesch Reading Ease). See Jeanne McGee, PhD, McGee & Evers Consulting, Inc., Part 7: Using Readability Formulas: A Cautionary Note, in Toolkit for Making Written Material Clear and Effective, (Sept. 2010), https://www.cms.gov/Outreach-and-Education/Outreach/WrittenMaterialsToolkit/Downloads/ToolkitPart07.pdf [https://perma.cc/Y3GB-92U4] [hereinafter CMS Toolkit Part 7], at 1.

146 CMS Toolkit Part 3, supra note 140, at 10. Because the average adult in the United States reads at an 8th grade level, the National Institutes of Health (NIH) and the American Medical Association (AMA) recommend the readability of patient materials be at or below 6th grade reading level. Adam E. M. Eltorai et al., Readability of Invasive Procedure Consent Forms, 8 Clin. Transl. Sci. 830 (2015).

147 See CMS Toolkit Part 7, supra note 145, at 5; Morales & Barriage, supra note 137.

148 See Morales & Barriage, supra note 137.

149 See CMS Toolkit Part 7, supra note 145, at 15-16.

150 Ali, supra note 134, at 1588.

151 Mark Pennington, Should We Teach Reading Comprehension Strategies?, Literacy Daily (Jul. 6, 2018), https://www.literacyworldwide.org/blog/literacy-daily/2018/07/06/should-we-teach-reading-comprehension-strategies [https://perma.cc/VDS3-M4D3].

152 See Dubé, supra note 69, at 4201; Nancy Kass et al., A Pilot Study of Simple Interventions to Improve Informed Consent in Clinical Research: Feasibility, Approach, and Results, 12 Clin. Trials 54, 63-65 (2015); Perrenoud et al., supra note 135, at 84; Schenker et al., supra note 136, at 151.

153 Similar approaches were presented in the general context of informed consent. See Ali, supra note 134, at 1578.

154 For similar approaches, see Petrelli et al., supra note 66, at 92-93; see also P. Kinnersley et al., Interventions to Promote Informed Consent for Patients Undergoing Surgical and Other Invasive Healthcare Procedures, Cochrane Database Systematic Revs. (2013), http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD009445.pub2/pdf [https://perma.cc/2SX9-ZCXM].

155 Ames et al., supra note 59, at 18-19.

156 See Julie Leask, et al., supra note 53, at 154; see also Corben & Leask, supra note 58, at 3172.

157 Corben & Leask, supra note 58, at 3170-73.

158 For a similar claim, see Kinnersley et al., supra note 154, at 125-26.

159 Ames et al., supra note 59, at 15.

160 Such strategies may include Internet-based platform with vaccine information and interactive social media. See generally Matthew, F. Daley et al., Addressing Parents' Vaccine Concerns: A Randomized Trial of a Social Media Intervention, 55 Am. J. Prev. Med. 44, 45, 52 (2018)Google Scholar.

161 Corben & Leask, supra note 58, at 3172.

162 See Eur. Ctr for Disease Prevention and Control, Communication on Immunisation, supra note 84, at 5.

163 See Dubé, supra note 69, at 4201.

164 Williams, supra note 53, at 2593.

165 See, e.g., Julia Belluz, Religion and vaccine refusal are linked. We have to talk about it., Vox, (Jun 19, 2019, 10:40AM), https://www.vox.com/2019/6/19/18681930/religion-vaccine-refusal [https://perma.cc/43NN-66R8].

166 This suggestion is supported by previous and current experience. See Wilhelmina LM Ruijs et al., The Role of Religious Leaders in Promoting of Vaccination Within a Minority Group: A Qualitative Study, BMC Public Health, Jan. 21, 2013, at 7.

167 Faden, supra note 37, at 256.

168 Id. at 257-258.

169 Id. at 258.

170 Id. at 258-59.

171 As the text indicates, persuasion efforts should be reasonable for the condition of free will to be fulfilled. Unyielding persuasive efforts could result in putting too much pressure onto parents, which they can't resist. Id. at 261-62.

172 While these techniques should be avoided, parents should be informed in an objective manner of the legal implications of not vaccinating their child, i.e. school entry vaccination requirements, depravation of child support payments. A separate question is who should provide them this information. Considering the importance of an open and non-judgmental communication between health providers and parents, we believe that the task of providing such information to parents should not be imposed on health providers.

173 Ames et al., supra note 59, at 19.

174 Id. at 15, 27.

175 Faden, supra note 37, at 252.

176 Dubé et al., supra note 52, at 1765, 1768.

177 Id. at 1769.

178 As we have claimed in the previous part, this assumption finds support in empirical findings. See also Weithorn & Reiss, supra note 31, at 1612-13.

179 Id., at 1613-14.

180 Id. at 1612, 1615.

181 CA 2781/93 Ali Da'aka v. Carmel Hosp., 53(4) PD 526, 572-73 (Aug. 28, 1999) (Isr.).

182 Patient's Rights Act, 5756-1996, SH No. 1591 art. 13, 13 (d), 15 (Isr.).

183 See, e.g., The Use of Hypnosis Law, 5744-1984, SH No. 1538 (Isr.).

184 Patient's Rights Act, 5756-1996, SH No. 1591 (Isr.).

185 Id.

186 This is in contrast to U.S. law. See National Vaccine Childhood Injury Act, 42 U.S.C. §§ 300aa to 300aa-34 (1986).

187 See Shelly Kamin-Friedman, Would It Be Legally Justified to Impose Vaccination in Israel? Examining the Issue in Light of the 2013 Detection of Polio in Israeli Sewage, Isr. J. of Health Pol'y Res. (2017), 6 (discussing CA 470/87 Alturi v. Isr. Ministry of Health 47(4) PD 146 (Aug. 24, 1993)).

188 Public Health Ordinance, 1940, I.R. 1065 (Isr.).

189 Patient's Rights Act, 5756-1996, SH No. 1591 (Isr.).

190 Basic Law: Human Dignity and Liberty Public Health Ordinance, 5752-1992, SH No. 1391 (Isr.).

191 Public Health Ordinance, 1940, I.R. 1065 (Isr.).

192 Id.

193 Id.

194 Id.

195 Patient's Rights Act, 5756-1996, SH No. 1591 (Isr.).

196 Id.

197 Id.

198 Id.

199 Id.

200 Id.

201 For characteristics of these public health interventions and a comparison to “regular” medical treatments, see James, F. Childress et al., Public Health Ethics: Mapping the Terrain, 30 J.L. Med. & Ethics 170, 170 (2002)Google Scholar.

202 Basic Law: Human Dignity and Liberty, 5752-1992, SH No. 1391 (Isr.).

203 See HCJ (Jerusalem) 7245/10 Adalah v. Ministry of Welfare & Soc. Affs. (June 4, 2013) (Isr.); CA 2781/93 Ali Da'aka v. Carmel Hosp., Haifa 53(4) PD 570–71 (Aug. 29, 1999) (Isr.); HCJ 4330/93 Ganem v. Israeli Bar Ass'n 50(4) PD 221, 231 (Oct. 13, 1996) (Isr.).

204 See Ali Da'aka v. Carmel Hosp. 53(4) PD 570–72 (Aug. 29, 1999) (Isr.); HCJ (Jerusalem) 7245/10 Adalah v. Ministry of Welfare & Soc. Affs. (June 4, 2013) (Isr.).

205 Basic Law: Human Dignity and Liberty, 5752-1992, SH No. 1391 (Isr.).

206 See HCJ (Jerusalem) 7245/10 Adalah v. Ministry of Welfare & Soc. Affs. (June 4, 2013) (Isr.).

207 See Kamin-Friedman, supra note 187 at 6 (citing Basic Law: Human Dignity and Liberty, 5752-1992, SH No. 1391 (Isr.)).

208 HJC (Jerusalem) 5304/15 Israeli Med. Ass'n v. Isr. Knesset (Sept. 11, 2016) (Isr.).

209 See Patient's Rights Act, 5756-1996, SH No. 1591, art. 13 (Isr.); Legal Capacity and Guardianship Law 1962, 120-1962, SH No. 380, art. 4 (Isr.)

210 Id. Although the law recognizes the existence of exceptions to the consent requirement, none is relevant to the case of routine childhood vaccination.

211 Id.; see also CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

212 Indeed, the health provider is obligated to inform the patient of the risks of not vaccinating a child. See Patient's Rights Act, 5756-1996, SH No. 1591 art. 13(b)(4) (Isr.). However, a parent is not obligated to participate in such an encounter. (Note that Hebrew is a gendered language, and the default is use of the masculine gender, which is understood to cover both genders. That custom was followed here to produce a consistent translation. The requirements are the same whether the acting parent is the mother or the father.)

213 Id.

214 Id.

215 Id.

216 See Patient's Rights Act, 5756-1996, SH No. 1591; CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

217 See CA (Jerusalem) 1355/11 Hadasa Med. Ctr. v. Mehuhedet Health Fund (Feb. 9, 2015), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

218 Id.

219 See CA (Jerusalem) 1997/10 Tsoref v. Rozenbaum (Feb. 13, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

220 Id.

221 See CA (Jerusalem) 4380/13 Rikman v. Clalit Health Fund (Jan. 13, 2015), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

222 See id.

223 See CA (Jerusalem) 1997/10 Tsoref v. Rozenbaum (Feb. 13, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

224 See Patient's Rights Act, 5756-1996, SH No. 1591 art. 13 (b).

225 See Patient's Rights Act, 5756-1996, SH No. 1591 art. 2.

226 See Patient's Rights Act, 5756-1996, SH No. 1591 art. 13 (b).

227 Id.

228 As the discussion above indicates the enactment of the Act did not abolish the doctrine of informed consent as articulated in courts' rulings. Therefore, when making a decision as to the scope of duty of disclosure consideration should also be given to courts' ruling. Contrary to the Act the courts did not define the duty of disclosure as limited to information that directly relates to the physical or mental condition of the patient or to the medical treatment. Instead, they focused on the general criteria through which the scope of the duty of disclosure is determined. See, for example: CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. ¶ 3 (Rivlin, J.) (Mar. 5, 2012), Nevo Legal Database (by subscription, in Hebrew) (Isr.). It follows, that the definition of the term “medical treatment” adopted by the Act, does not prevent the applying of the duty of disclosure to other types of information.

229 See CA 2781/93 Ali Da'aka v. Carmel Hosp., Haifa 53(4) PD 570–71 (Aug. 29, 1999) (Isr.).

230 Id.

231 Id.

232 See CA 4960/04 Sidi v. Clalit Health Fund (Jan. 13, 2015) (Isr.); CA (Jerusalem) 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012) (Isr.).

233 The physician's duty to inform the patient about alternative treatments is limited to treatments accepted by respectable medical bodies. See CA (Jerusalem) 6936/09 Yehuda v. Clalit Health Fund (Mar. 5, 2012), ¶¶ 15-16 (Rivlin, J.), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

234 See Patient's Rights Act, 5756-1996, SH No. 1591; see also Kamin-Friedman, supra note 187 at 6 (discussing duty to disclose information about vaccines in Israeli case law).

235 See CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶¶ 26-27 (Rivlin, J.), Nevo Legal Database (by subscription, in Hebrew) (Isr.).

236 CA 470/87 Altori v. Israel 47(4) PD 146 (Aug. 24, 1993) (Isr.).

237 Id.

238 Id.

239 Id.

240 Id.

241 Id.

242 Id.

243 Id.

244 The same line of reasoning was applied in Haliba v. Ministry of Health, decided by the District Court following Altori v. Israel. DC 1018/00 (Beer Sheve) Haliba v. Ministry of Health (Nov. 16, 2005) (Isr.).

245 In addition to existing in the U.S., school entry vaccination requirements exist in some Australian states or territories (e.g., New South Wales, Victoria, Tasmania and Australian Capital Territory). See Nat'l Ctr. for Immunization Res. & Surveillance, School Entry Vaccination Requirements: Summary of The Evidence 1, 3 (2013). Moreover, according to Australian federal legislation, some government benefits, such as the Family Tax Benefit Part A supplement, the Child Care Subsidy, and the Additional Child Care Subsidy, are paid only for children who have been vaccinated or who have a medical or conscientious exemption. See What Are Immunisation Requirements, Austl. Gov't Dep't of Health (July. 1, 2019), https://www.humanservices.gov.au/individuals/topics/what-are-immunisation-requirements/35396#a5. [https://perma.cc/E2JQ-B8UK]. In Canada, three provinces—Ontario, New Brunswick and Manitoba—have legislated vaccination policies, which apply strictly to children about to enroll in school. See Erin Walkinshaw, Mandatory Vaccinations: The Canadian Picture, 183 Can. Med. Ass'n J. E1165, E1165–66 (2011). See also For the Public: Is Immunization Mandatory in Canada?, Immunize Canada (Apr. 18, 2019), https://immunize.ca/immunization-mandatory-canada [https://perma.cc/6E7B-MXCU]. Measures to enforce mandatory vaccination that are more stringent have been adopted in other countries. For example, Slovenia adopted a mandatory program for nine designated diseases, and a failure to comply results in a fine. See Walkinshaw, supra, at E1167–68.

246 Other countries share Israel's non-mandatory vaccination policy. In a study of vaccination programs and policies in the EU, Iceland, and Norway, 15 of the 29 total countries (including the U.K.) were not found to mandate any vaccines. See M. Haverkate et al., Mandatory and Recommended Vaccination in the EU, Iceland and Norway: Results of the VENICE 2010 Survey on the Ways of Implementing National Vaccination Programs, 17 Euro Surveillance 1 (2012).

247 Over the years, there have been calls for a mandatory vaccination policy. These assertions were followed by several initiatives to impose a legal obligation on parents to vaccinate their children. See Adopting School Entry Vaccination Requirements, Haifa Dist. Health Off., Ministry of Health (Feb. 17, 2008), http://www.health.gov.il/Services/Committee/IDAC/Documents/CMV17022008.pdf [https://perma.cc/V6FK-MUPJ] (Isr.); Meeting Summary of the Advising Committee Regarding Infectious Diseases and Vaccines, Using Children Enrolment to Kindergarten to Improve Childhood Vaccination Rates and Integrating the HPV Vaccine to School Vaccination Program, Ministry of Health (Jan. 30, 2013), http://www.health.gov.il/Services/Committee/IDAC/Documents/CMV11022013.pdf [https://perma.cc/T38JHUQF] (Isr.); Vaccination Program for Children, Adults and Health Staff, State Comptroller of Israel (2014), http://www.mevaker.gov.il/he/Reports/Report_248/c51ffb79-e3a9-49b3-9654-8054462506ba/214-ver-4.pdf [https://perma.cc/38KC-TVXB] (Isr.). In 2009, the Law for Economic Efficiency was enacted. Law for Economic Efficiency (Legislative Amendments to Implement the Economic Program), 2009-2010 SH No. 2203 (Isr.) (2009). Article 61(2)(d) of this law included Amendment 113 to the Social Security Law [Consolidated Version], 1995, S.H. 1522, p. 210 (Isr.). The amendment, which was included in art. 68 (d) of the Social Security Law, ordered the reduction of allowances for children who were not vaccinated according to the vaccination program adopted by the Ministry of Health. A petition that was filed in the High Court of Justice to declare the amendment as unconstitutional was refused. See generally HCJ 7245/10 Adalah v. Minister of Welfare & Soc. Aff. (June 4, 2013) (Isr.). In 2013, this amendment was canceled, through Amendment 147 to the Social Security Law. See Law for the Change of National Priorities (Legislative Amendments for the Achievement of Budgetary Goals for the Years 2013 and 2014), 2013, SH No. 2405 (Isr.). Following the severe measles outbreak Israel has been experiencing since March 2018, a new legal initiative is now under consideration: Bill for Amendment of the Public Health Ordinance (No. 34) (National vaccination policy and vaccination incentives) (5786/20/P) (2018) (Isr.), https://main.knesset.gov.il/activity/legislation/laws/pages/lawbill.aspx?t=lawsuggestionssearch&lawitemid=2075056 [https://perma.cc/3U56-JR2Z] (transferred to the Committee for preparation to second and third reading). Among other things the bill obligates a refusing parent to sign a refusal declaration and to be informed about vaccines. It also authorizes the MHI to close an educational institute in a case of an outbreak or to forbid the entrance of non-vaccinated children to the institute.

248 For the authority of the Ministry of Health Director General to take measures for the protection of the public from an infectious disease, see infra note 249.

249 The Public Health Ordinance, 1940, authorizes the Ministry of Health Director General to declare a mandatory vaccination in circumstances where there is a risk to the public owing to an infectious disease. Nevertheless, this authority was invoked rarely and was never invoked for routine child vaccinations. See Michal, Alberstein & Nadav, Davidovich, Therapeutic Jurisprudence and Public Health: Israeli Perspectives, 26 Bar Ilan L. Stud. 549, 577 (2010)Google Scholar (Isr.) Nevertheless, following the current measles outbreak this authority was invoked three times. In all cases the MHI forbid non-vaccinated children from entering kindergartens. See Means Yasur Beit Or, Due to Concern About Measles: 120 Unvaccinated Students Were Removed From The School In Hadera, Israel Today (June 20, 2019), https://www.israelhayom.co.il/article/667001 [https://perma.cc/2LPZ-JKHM]; Means Yasue Beit Or, Children Not Vaccinated Against Measles Were Banned, Israel Today (Dec. 25, 2018), https://www.israelhayom.co.il/article/618829 [https://perma.cc/4ZWG-A5SS]; Ido Efrati, The Ministry of Health Prohibits Children Who Are Not Vaccinated Against Measles Into Gardens In A Community Setting, Haaretz (Jan. 15, 2019), https://www.haaretz.co.il/news/health/1.6845555 [https://perma.cc/N837-7WWZ].

250 Vaccine Injuries Insurance Law, 5750-1989, art. 4(A) (Isr.); Polio Victims Compensation Law, 5767-2007, art. 2 (Isr.).

251 See Vaccine Injuries Insurance Law, 5750-1989, art. 4(A) (Isr.).

252 Polio Victims Compensation Law, 5767-2007, art. 2 (Isr.).

253 See Vaccine Injuries Insurance Law, 5750-1989, art. 2 (c) (Isr.); Polio Victims Compensation Law, 5767-2007, art. 2 (Isr.).

254 See Vaccine Injuries Insurance Law, 5750-1989, art. 7 (Isr.); Polio Victims Compensation Law, 57-67-2007, art. 10(a) (Isr.).

255 CA 2781/93 Ali Da'aka v. Carmel Hosp. 53(4) PD 526 (Aug. 8, 1999) (Isr.).

256 See CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶¶ 26-27 (Rivlin, J.), Nevo Legal Database (by subscription, in Hebrew) (Isr.); CA 2781/93 Ali Da'aka v. Carmel Hosp. 53(4) PD 526, 564 (Aug. 8, 1999) (Isr.).

257 CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶ 33 (Rivlin, J.); CA 2781/93 Ali Da'aka v. Carmel Hosp. (Aug. 8, 1999) (Isr.).

258 CA 1303/09 Kadosh v. Bikur Holim Hosp. (Mar. 5, 2012), ¶ 48 (Rivlin, J.).

259 National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-26 (2012).

260 See Truman v. Thomas, 611 P.2d 902 (1980).

261 National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-11(a)(2) (2012).

262 42 U.S.C. §§ 300aa-1 to 300aa-34.

263 42 U.S.C. § 300aa-26.

264 42 U.S.C. § 300aa-11(a)(2).

265 42 U.S.C. § 300aa-22 (c).

266 Jaime Staples King & Benjamin W. Moulton, Rethinking Informed Consent: The Case for Shared Medical Decision-Making, 32 Am. J.L. & Med. 429, 437-445 (2006).

267 Lawrence, Schlam & Joseph, P. Wood, Informed Consent to the Medical Treatment of Minors: Law and Practice, 10 Health Matrix 141, 148-150 (2000)Google Scholar. (Note that, while Schlam & Wood criticize the extent of the parental informed consent doctrine and raise an exception, such exploration is beyond the scope of this article.).

268 42 U.S.C. § 300aa-26 (a).

269 Administrative Procedure Act, 5 U.S.C. §553 (2018). Though not necessarily the complications added to the process by judicial review and other sources. But see Jeffrey, S. Lubbers, The Transformation of the U.S. Rulemaking Process - For Better or Worse, 34 Ohio N.U. L. Rev. 469, 471, 481-82 (2008)Google Scholar (explaining additional complications added to the process by judicial review and other sources).

270 42 U.S.C. §§ 300aa-26 (b)(1).

271 42 U.S.C. § 300aa-26(b)(2); see also Advisory Commission on Childhood Vaccines (ACCV), Health Res. & Servs. Admin. (Feb. 2019), https://www.hrsa.gov/advisory-committees/vaccines/index.html [https://perma.cc/K244-7FA9]. The Committee “advises and makes recommendations to the Secretary of Health and Human Services on issues relating to the operation of the National Vaccine Injury Compensation Program (VICP).” Id. Members include healthcare providers, attorneys, including those representing families with vaccine injuries, and parents of children compensated for vaccine harms. Advisory Commission on Childhood Vaccines (ACCV) Roster, Health Res. & Servs. Admin. (2019), https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/accvroster.pdf [https://perma.cc/3XWG-8JN5].

272 Vaccine Information Statements (VISs), Ctrs. for Disease Control and Prevention (Apr. 5, 2019), https://www.cdc.gov/vaccines/hcp/vis/index.html [https://perma.cc/8ZRJ-XDUY].

273 See, e.g., MMR (Measles, Mumps, and Rubella) VIS, Immunization Action Coalition (Aug. 15, 2019), http://www.immunize.org/vis/vis_mmr.asp [https://perma.cc/CT4E-K94Y].

274 Vaccine Information Statements (VISs), supra note 272.

275 42 U.S.C. § 300aa-26(d)(2).

276 42 U.S.C. § 300aa-26(c).

277 Vaccine Information for Parents, Patients, and Health Care Providers, Alaska Dep't of Health and Soc. Servs., http://dhss.alaska.gov/dph/Epi/iz/Pages/parents.aspx [https://perma.cc/ZD3PHKYR] (last visited Jan. 19, 2019).

278 Laws and Regulations, Immunization Branch, Cal. Dep't of Pub. Health (May 15, 2018). https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Immunization/laws.aspx [https://perma.cc/H8Y6-938N].

279 Vaccine Information Statements, Disease Outbreak Control Div., Haw. Dep't of Health (Apr. 2019), http://health.hawaii.gov/docd/for-healthcare-providers/vaccine-resources/vaccine-information-statements [https://perma.cc/ND3H-WR46].

280 Vaccine Information Statements, Or. Health Auth., https://www.oregon.gov/oha/ph/PreventionWellness/VaccinesImmunization/Pages/vis.aspx [https://perma.cc/2ZNJ-CGBC] (last visited Jan. 19, 2019).

281 Vaccine Administration and Clinical Guidance, Mass. Dep't of Pub. Health, https://www.mass.gov/service-details/flu-information-for-healthcare-and-public-health-professionals [https://perma.cc/HKR2-TCDH] (last visited Jan. 19, 2019).

282 Vaccine Information Statements, N.Y. State Dep't of Health (Apr. 2016), https://www.health.ny.gov/prevention/immunization/vms.htm [https://perma.cc/C7LK-ZQJJ].

283 Important Vaccine Information Statement (VIS) Facts, Mich. Dep't of Health and Hum. Servs. (2019), https://www.michigan.gov/documents/mdch/newerVIS_1212_180697_7.pdf [https://perma.cc/RA6K-MWS6]. The additional text on Michigan's VIS reads: “To allow medical care provider(s) accurate immunization status information, an immunization assessment, and a recommended schedule for future immunizations, information will be sent to the Michigan Care Improvement Registry. Individuals have the right to request that their medical care provider not forward immunization information to the Registry.” See, e.g., Varicella (Chickenpox) Vaccine: What You Need to Know, Mich. Dep't of Health and Hum. Servs. (2019) https://www.michigan.gov/documents/_1Chickenpox_153512_7.pdf [https://perma.cc/ZD2P-D58G].

284 See Talking to Vaccine Hesitant Parents, Louisiana Dep't of Health, http://ldh.la.gov/index.cfm/page/3676 [https://perma.cc/M3HK-SRR8] (last visited Oct. 16, 2019) (discussing proper documentation practices when parents refuse vaccination for their child). That page contains a link to the “Refusal to Vaccinate Form.” Decision Not to Vaccinate My Child, Louisiana Dep't of Health (2016), https://www.immunize.org/catg.d/p4059.pdf [https://perma.cc/AD8R-ZJMN]; Vaccine Documentation/Consent Form, Kansas Dep't of Health and Environment (2014), http://www.kdheks.gov/immunize/imm_manual_pdf/Documentation_Consent_Form_English.pdf [https://perma.cc/Q4UJ-YY9W].

285 See, e.g., Requirements to Administer Influenza Vaccination, Md. Dep't of Health (Sept. 27, 2012) https://health.maryland.gov/pharmacy/docs/BOP-Forms/Requirements%20to%20Administer%20Influenza%20Vaccination%20092712.pdf [https://perma.cc/ZF4B-HNVP] (requiring pharmacists who administer influenza vaccinations to obtain signed consent from patients).

286 Examples include Indiana and Tennessee. See, e.g., Refusal to Vaccinate Form, Ind. St. Dep't of Health (2002), https://www.in.gov/isdh/files/Refusal_to_Vaccinate_Form.pdf [https://perma.cc/QW3QAVJ7]; see also Tennessee Influenza Vaccination Consent or Declination Record, Tenn. Dep't of Health, https://www.tn.gov/content/dam/tn/health/documents/SampleFacilityFluForm.pdf [https://perma.cc/YE92-UHYM] (last visited Jan. 19, 2019).

287 Truman v. Thomas, 611 P.2d 902, 904 (1980).

288 Id. at 288-289.

289 Id. at 292-293.

290 In a recent article hosted by the American Academy of Pediatrics, a doctor reminded other doctors that failure to get (or document) informed refusal for not vaccinating can lead to liability. James P. Scibilia, Document ‘Informed Refusal' Just as You Would Informed Consent, AAP News (Oct. 30, 2018), http://www.aappublications.org/news/2018/10/30/law103018?fbclid=IwAR2_CT4jUhYBAlPSYOJ81tD4HmHDb0ERSaBDxKQ1r3YL0KK4cUQ8dd3CDM [https://perma.cc/5UY8-UQRH]. The article is written as if referring to an actual case, but an email to the author did not produce a recent case on point. Instead, the author mentioned that he “believe[d] it occurred in the 80s and may have involved an out of court settlement … I believe Kaiser had a similar case, settled out of court, about 10 [years] ago.” Email from James P. Scibilia, Pediatrics, Heritage Valley Health System, to Dorit R. Reiss, Professor of Law, U.C. Hastings College of the Law (Dec. 5, 2018, 19:05 PST) (on file with author). We have found no such case in the 1980s. Furthermore, the scenario described could not have happened then, since infants were not vaccinated with pneumococcal vaccines until the 2000s. See Pneumococcal Disease, Epidemiology and Prevention of Vaccine-Preventable Diseases, Ctrs. for Disease Control and Prevention (Apr. 15, 2019), https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html#vaccines [https://perma.cc/TFA6-ZG65]. We therefore assume the situation is hypothetical; nonetheless, the article still reflects the state of the law as set by Truman v. Thomas.

291 Dorit, Rubinstein Reiss & Lois, A. Weithorn, Responding to the Childhood Vaccination Crisis: Legal Frameworks and Tools in the Context of Parental Vaccine Refusal, 63 Buff. L. Rev. 881, 892-93, 968-69 (2016)Google Scholar.

292 Id. at 915-18.

293 Univ. of Cal. Press, Regents of the Univ. of Cal., Public Health Law and Ethics: A Reader, 424-425 (Lawrence O. Gostin and Lindsay F. Wiley eds., 3d ed. 2018); see also Jesse McKinley, Measles Outbreak: N.Y. Eliminates Religious Exemptions for Vaccinations, N.Y. Times (June 13, 2019), https://www.nytimes.com/2019/06/13/nyregion/measles-vaccinations-new-york.html [https://perma.cc/7JJVF9C6].

294 Evan Simko-Bernardski, Maine Bars Residents from Opting Out of Immunizations for Religious or Philosophical Reasons, CNN (May 27, 2019), https://www.cnn.com/2019/05/27/health/maine-immunization-exemption-repealed-trnd/index.html [https://perma.cc/6NRU-3MLY].

295 See Colo. Rev. Stat. § 25-4-903 (2019) (allowing exemptions for medical reasons, religious beliefs, and personal beliefs); see Minn. Stat. § 121A.15 (2019) (allowing exemptions for medical reasons and “conscientiously held beliefs”); see also Nili Karako-Eyal, Beyond the Ethical Boundaries of Solidarity: Increasing Vaccination Rates through Mandatory Education to Solidarity, 6 Tex. A&M L. Rev. 345, 355 (claiming that “lenient states” like Colorado and Minnesota “only require that parents sign a statement indicating their religious or personal opposition to vaccination”).

296 Reiss and Weithorn, supra note 291, at 917.

297 See infra, text accompanying notes 312-21. For a detailed discussion of such requirements, see Karako-Eyal, supra note 295, at 355-359 (2019).

298 See Varun, K. Phadke et al., Association Between Vaccine Refusal and Vaccine-Preventable Diseases in the United States: A Review of Measles and Pertussis, 315 J. of the Am. Med. Ass'n 1149, 1150-55 (2016)Google Scholar (noting that the risk of an outbreak increases when there are more unvaccinated children in an area).

299 Allison v. Merck & Co., 878 P.2d 948, 961 (Nev. 1994).

300 Id. at 948.

301 42 U.S.C. §300aa-11 (2012).

302 Allison, 878 P.2d at 961.

303 Driving and Transportation, Epilepsy Foundation (Oct. 23, 2013), https://www.epilepsy.com/living-epilepsy/driving-and-transportation [https://perma.cc/VR6Y-KGHM].

304 See id.; see also, e.g., California Driver Licensing Laws, Epilepsy Foundation (Aug. 2014), https://www.epilepsy.com/driving-laws/2008336 (“The Department of Motor Vehicles may consider the following elements when evaluating a person with a seizure disorder … the individual's compliance with a prescribed medical regimen.”).

305 City of Newark v. J.S., 652 A.2d 265, 268 (1993). Similar laws exist in a number of states. See Oscar A. Cabrera, et al., Express Tuberculosis Control Laws in Selected U.S. Jurisdictions, Ctrs. for Law & the Public's Health 1, 26-51 (2008), http://www.cdc.gov/phlp/docs/Centers_Report-Express_TB_Control_Laws-Final.pdf [https://perma.cc/XK5S-BH6H].

306 See Tuberculosis, World Health Organization (Sept. 18, 2018), http://www.who.int/news-room/fact-sheets/detail/tuberculosis [https://perma.cc/2AGU-UZB7] (“People with active TB can infect 10-15 other people through close contact over the course of a year.”).

307 Vaccine-Preventable Adult Diseases, Ctrs. for Disease Control and Prevention (May 2, 2016), https://www.cdc.gov/vaccines/adults/vpd.html [https://perma.cc/BGH8-BC7S] (“Vaccine-preventable diseases cause long-term illness, hospitalization, and even death.”).

308 See, e.g., How Far Americans Live from the Closest Hospital Differs by Community Type, Pew Research Ctr. (Dec. 12, 2018), https://www.pewresearch.org/fact-tank/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type [https://perma.cc/NQ67-8NBR] (“Rural Americans live an average of 10.5 miles from the nearest hospital, compared with 5.6 miles for people in suburban areas and 4.4 for those in urban areas …”).

309 See, e.g., Epilepsy and Driving, Epilepsy Foundation (Aug. 26, 2015), https://www.epilepsy.com/article/2015/8/epilepsy-and-driving [https://perma.cc/W5P4-DZ3D] (discussing restrictions on people with epilepsy for getting a driver's license).

310 Dorit Rubinstein Reiss, Rights of the Unvaccinated Child, in 73 Stud. in L., Pol., and Soc'y 83, 89 (Austin Sarat ed., 2017).

311 Reiss and Weithorn, supra note 291, at 961-962.

312 Karako-Eyal, supra note 295, at 355-359

313 Id. at 355-56.

314 Denise, F. Lillvis et al., Power and Persuasion in the Vaccine Debates: An Analysis of Political Efforts and Outcomes in the United States, 1998-2012, 92 Milbank Q. 475, 502 (2014)Google Scholar.

315 Wash. Admin. Code § 246-105-050 (2015) (“Before a child may attend a school or child care center, a parent must provide proof of immunization status using the following documentation … [a] place to indicate whether the parent is claiming a medical, religious, personal, or philosophical exemption. This must include … [a] statement signed and dated by a health care practitioner stating that he or she has provided the parent information about the benefits and risks of immunization to the child as a condition of obtaining a medical, religious, personal, or philosophical exemption.”). The California law was later repealed. Cal. Health & Safety Code § 120365 (b)(1) (West 2015) (repealed 2016) (“A signed attestation from the health care practitioner that indicates that the health care practitioner provided the parent or guardian of the person who is subject to the immunization requirements of this chapter … with information regarding the benefits and risks of the immunization and the health risks of the communicable diseases … to the person and to the community. This attestation shall be signed not more than six months before the date when the person first becomes subject to the immunization requirement for which exemption is being sought.”).

316 Or. Rev. Stat. § 433.267(1)(c)(B) (2015) (“(i) A signature from a health care practitioner verifying that the health care practitioner has reviewed with the parent information about the risks and benefits of immunization that is consistent with information published by the Centers for Disease Control and Prevention and the contents of the vaccine educational module approved by the authority pursuant to rules adopted under ORS 433.273; or (ii) A certificate verifying that the parent has completed a vaccine educational module approved by the authority pursuant to rules adopted under ORS 433.273.”).

317 Denise, Lillvis, Managing Dissonance and Dissent: Bureaucratic Professionalism and Political Risk in Policy Implementation, 41 L. & Pol'y 310, 310 (2019)Google Scholar.

318 Karako-Eyal, supra note 295, at 357-58.

319 Id. at 356.

320 Id. at 358.

321 Id. at 359.

322 See Y., Tony Yang & Ross, D. Silverman, Legislative Prescriptions for Controlling Nonmedical Vaccine Exemptions, 313 JAMA 247 (2015)Google Scholar.

323 See, e.g., Nina R. Blank et al., Exempting Schoolchildren from Immunizations: States with Few Barriers Had Highest Rates of Nonmedical Exemptions, 32 Health Aff. 1282, 1282 (2013). Though scholars do point to the limits of this approach, and the fact that making exemptions harder to get will not affect those with strong safety concerns about vaccines. Eileen Wang et al., Nonmedical Exemptions from School Immunization Requirements: A Systematic Review, 104 Am. J. Pub. Health e62, e80, e81-82 (2014).

324 See Truman v. Thomas, 611 P.2d 902 (1980).

325 See Ross, D. Silverman, No More Kidding Around: Restructuring Non-Medical Childhood Immunization Exemptions to Ensure Public Health Protection, 12 Annals Health L. 277, 294 (2003)Google Scholar.

326 Id.

327 See Truman, 611 P.2d at 904.

328 Silverman, supra note 325, at 294.

329 42 U.S.C. § 300aa-11(a)(2)(A) (2012). On the program, see Nora, Freeman Engstrom, A Dose of Reality for Specialized Courts: Lessons from the VICP, 163 U. Pa. L. Rev. 1631 (2015)Google Scholar. Design defect claims against manufacturers cannot, under Supreme Court jurisprudence, be brought in state courts at all, but there is no similar limit on informed consent suits against providers. Bruesewitz v. Wyeth, 131 S. Ct. 1068, 1082 (2011).

330 See Engstrom, supra note 329, at 1672, 1696.

331 See id. at 1673. Westlaw, Lexis, and Google searches turned up no cases of parties who went to civil courts using a theory of informed consent after rejecting VICP settlement.

332 Karako-Eyal, supra note 30, at 934-35.

333 See supra Section IV.A; Isr. Ministry of Health, The Guide to Vaccines Injection (2014), https://www.health.gov.il/PublicationsFiles/TadrichHisunim_21072014.pdf [https://perma.cc/H9YC-66WF] [hereinafter Guide to Vaccines Injection (2014)]; Isr. Ministry of Health, The Vaccines Guide (2017), https://www.health.gov.il/UnitsOffice/HD/PH/epidemiology/td/docs/tadrich_Chisunim.pdf [https://perma.cc/9HMB-6UFX] [hereinafter Vaccines Guide (2017)].

334 Unfortunately, we could not find an empirical study exploring the practice of informed consent to vaccination in Israel. EBSCO and ProQuest searches, as well as google searches, using a variety of terms turned up no such studies. Appeal to researchers in this field yielded no results as well.

335 See Vaccines for Babies and Children, Isr. Ministry of Health, supra note 33.

336 Id.

337 Circulate 57/97: Providing Information to Women Giving Birth During Hospitalization, Isr. Ministry of Health (Sep. 16, 1997), https://www.health.gov.il/hozer/mr57_1997.pdf [https://perma.cc/G7QP-DJX9].

338 Id.

339 Id.

340 Id.

341 Circulate 17/99: Providing Information to a Women Giving Birth During Hospitalization, Isr. Ministry of Health (Apr. 12, 1999), https://www.health.gov.il/hozer/mr17_1999.pdf [https://perma.cc/K25A-J9TA].

342 Id.

343 Id.

344 Id.

345 Id.

346 Id.

347 Id.

348 For comparison, see the information presented in the WHO website regarding infectious Hepatitis B. See Hepatitis B, World Health Org. http://www.who.int/news-room/fact-sheets/detail/hepatitis-b [https://perma.cc/K27X-EUEU].

349 Circulate 17/99, supra note 341.

350 See Guide to Vaccines Injection, supra note 333.

351 See Tipat Halav – Family Health Centers, State of Isr. Ministry of Health, https://www.health.gov.il/English/Topics/Pregnancy/health_centers/Pages/family_health_centers.aspx [https://perma.cc/C36E-2L7J].

352 See Vaccines Guide (2017), supra note 333; Guide to Vaccines Injection (2014), supra note 333.

353 Vaccines Guide (2017), supra note 333.

354 Guide to Vaccines Injection (2014), supra note 333.

355 Id.

356 Id.

357 Id.

358 Id.

359 Id.

360 Id.

361 Id.

362 Isr. Ministry of Health, Childhood Vaccines (2017), https://www.health.gov.il/PublicationsFiles/alon_hisunim.pdf [https://perma.cc/7QE9-7HPW] [hereinafter Childhood Vaccines (2017)]. The pamphlet is available in Hebrew and Arabic.

363 Id.

364 Id.

365 Id.

366 Id.

367 Id.

368 Id.

369 Id.

370 Id.

371 Id.

372 Id.

373 Id.

374 Id.

375 Id.

376 Id.

377 Id.

378 Efficacy and Effectiveness, The Immunisation Advisory Centre (Apr. 2017) http://www.immune.org.nz/vaccines/efficiency-effectiveness [https://perma.cc/7KW6-QY5M].

379 Childhood Vaccines (2017), supra note 362.

380 Vaccines for Babies and Children, Isr. Ministry of Health, supra note 33.

381 Childhood Vaccines (2017), supra note 362.

382 Vaccines for Babies and Children, Isr. Ministry of Health, supra note 33.

383 Id.

384 See Isr. Ministry of Health, Guidelines on Parental Consent to the Vaccination of Their Child in School (June 17, 2018), https://www.health.gov.il/hozer/17062018.pdf [https://perma.cc/6NJM-9KHL].

385 Id.

386 The phrase “the general press” is the exact phrase used in the guidelines. Id. Although the guidelines don't clarify what this phrase means, it likely means “commonly read, major newspapers.”

387 Id.

388 Circulate 0083: Parental Declaration Regarding the Health of a Child and Consent to the Provision of Student Health Services, Isr. Ministry of Education (Apr. 20, 2018), http://apps.education.gov.il/Mankal/Horaa.aspx?siduri=93 [https://perma.cc/R98C-XR7Y].

389 Id.

390 Id.

391 See Circulate 0083, supra note 388.

392 Id.

393 Id.

394 Id.

395 Isr. Ministry of Health & Natali Education and Training Unit, Students' Health Services at Schools (2017-2018), https://www.health.gov.il/PublicationsFiles/school_health_services.pdf [https://perma.cc/ARK7-J9S7].

396 Id.

397 Id. The form is also available in Arabic on the Natali Healthcare Solutions website. See Students' Health Services at Schools (2017-2018), http://www.natali.co.il/_Uploads/dbsAttachedFiles/horearabic.pdf [https://perma.cc/V3BD-GZXC].

398 Id.

399 Id.

400 Dept. of Public Health Nursing, Information Sheet for Parents Before the Administration of Infl. TIV (2016), https://www.health.gov.il/Subjects/KidsAndMatures/school/vaccines/Documents/Influ-parents.pdf [https://perma.cc/ECE7-GZKK] [hereinafter Infl. TIV Information Sheet]; Dept. of Public Health Nursing, Information Sheet for Parents Before the Administration of MMRV (2016), https://www.health.gov.il/Subjects/KidsAndMatures/school/vaccines/Documents/mmrv-parents.pdf [https://perma.cc/N24N-4KZR] [hereinafter MMRV Information Sheet]; Dept. of Public Health Nursing, Information Sheet for Parents Before the Administration of Tdap (2016), https://www.health.gov.il/Subjects/KidsAndMatures/school/vaccines/Documents/Tdap-parents.pdf [https://perma.cc/U747-WE2E] [hereinafter Tdap Information Sheet]; Dept. of Public Health Nursing, Information Sheet for Parents Before the Administration of Tdap-IPV (2016), https://www.health.gov.il/Subjects/KidsAndMatures/school/vaccines/Documents/Tdap-IPV-parents.pdf [https://perma.cc/N5WJ-6733] [hereinafter Tdap-IPV Information Sheet]; Dept. of Public Health Nursing, Information Sheet for Parents Before the Administration of HPV (2019), https://www.health.gov.il/Subjects/KidsAndMatures/school/vaccines/Documents/HPV-school.pdf [https://perma.cc/S39S-VYX3] [hereinafter HPV Information Sheet]. Both the sheets and the Parental Declaration regarding the health of a child and consent to the provision of student health services are in Hebrew. An interview with Bella Elran, Assistant to the National Inspector of Public Health, revealed that the Ministry of Health and the Ministry of Education believe that the responsibility for the translation of these documents into Arabic rests with the schools. Accordingly, there are no versions of these documents in Arabic on the websites of the Ministry of Health and the Ministry of Education. See Interview with Bella Elran, Assistant to the National Inspector of Public Health – Epidemiology (Aug. 16, 2018).

401 Circulate 12/2015: Students' Health Services (2015), Isr. Ministry of Health (Sep. 4, 2015), https://www.health.gov.il/hozer/bz12_2015.pdf [https://perma.cc/V65T-UQB3].

402 See, e.g., HPV Information Sheet, supra note 400.

403 Id.

404 Id.

405 See, e.g., Tdap Information Sheet, supra note 400.

406 See information sheets for TIV, MMRV, Tdap, Tdap-IPV, and HPV, supra note 400.

407 HPV Information Sheet, supra note 400.

408 Tdap Information Sheet, supra note 400; Tdap-IPV Information Sheet, supra note 400.

409 Infl. TIV Information Sheet, supra note 400; MMRV Information Sheet, supra note 400.

410 See, e.g., Infl. TIV Information Sheet, supra note 400.

411 Id.

412 See, e.g., Vaccines of Children and Babies, Isr. Ministry of Health, https://www.health.gov.il/Subjects/pregnancy/Childbirth/Vaccination_of_infants/Pages/default.aspx [https://perma.cc/NZ49-DLLS]; Description of Vaccines for Children and Babies, Isr. Ministry of Health, https://www.health.gov.il/Subjects/pregnancy/Childbirth/Vaccination_of_infants/Pages/vaccines_babies.aspx [https://perma.cc/NQ4F-BUDJ]; Vaccines for Babies and Children – Questions and Answers, Isr. Ministry of Health, https://www.health.gov.il/Subjects/pregnancy/Childbirth/Vaccination_of_infants/Pages/questions_answers.aspx [https://perma.cc/28ST-ZZKA]; There is No Connection Between Vaccination and Autism, Isr. Ministry of Health, https://www.health.gov.il/Subjects/pregnancy/Childbirth/Vaccination_of_infants/Pages/No_conection_autism.aspx [https://perma.cc/BR69-Y5ZM]; How Vaccination Works, Isr. Ministry of Health, https://www.health.gov.il/Subjects/pregnancy/Childbirth/Vaccination_of_infants/Pages/Immune_activity.aspx [https://perma.cc/M9EA-QTL6]; Protect Your Child from Influenza – Vaccinate Them Every Year in the Fall or in the Winter, Isr. Ministry of Health, https://www.health.gov.il/Subjects/pregnancy/Childbirth/Vaccination_of_infants/Pages/flu_children.aspx [https://perma.cc/XA9E-GG38]; Flu Vaccine Provided in Schools – Questions and Answers, Isr. Ministry of Health, https://www.health.gov.il/Subjects/pregnancy/Childbirth/Vaccination_of_infants/Pages/flu_school.aspx [https://perma.cc/U2FU-NYQZ]. Most of the information regarding vaccination found in the IMH website is also presented in Arabic and English.

413 See, e.g., Infl. TIV Information Sheet, supra note 400.

414 Id.

415 For example, the MMRV information sheet uses the phrase: “Long term immunity,” without providing explanation to this phrase. MMRV Information Sheet, supra note 400.

416 U.S. Dep't of Health and Human Services, 2019 Recommended Vaccinations for Infants and Children, Ctrs. for Disease Control and Prevention (Feb. 5, 2019), https://www.cdc.gov/vaccines/schedules/easy-to-read/child-easyread.html#table-child [https://perma.cc/8UC3-PLLK].

417 U.S. Dep't of Health and Human Services, Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, Ctrs. for Disease Control and Prevention (Feb. 22, 2019), https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf [https://perma.cc/NQ6J-RPSR].

418 See, e.g., id.

420 Fernando Stein & Karen Remley, American Academy of Pediatrics Emphasizes Safety and Importance of Vaccines, American Academy of Pediatrics (Jan. 10, 2017) https://www.aap.org/enus/about-the-aap/aap-press-room/Pages/American-Academy-of-Pediatrics-Emphasizes-Safety-and-Importance-of-Vaccines.aspx [https://perma.cc/TSY2-ECXW].

421 Id. See also Childhood Immunization Support Program, AAP Immunization Resources Best Practices, American Academy of Pediatrics (Aug. 2013), https://www.aap.org/enus/Documents/immunization_nvac_standard7.pdf [https://perma.cc/L23M-2FZR].

422 See National Vaccine Program Office, National Vaccine Advisory Committee (NVAC), U.S. Dept. of Health & Human Services (May 23, 2018), https://www.hhs.gov/nvpo/nvac/index.html [https://perma.cc/AGE7-VGGD].

423 Childhood Immunization Support Program, AAP Immunization Resources Best Practices, supra note 421.

424 National Vaccine Advisory Committee, Dept. of Health and Human Services (May 23, 2018), https://www.hhs.gov/vaccines/nvac/index.html [https://perma.cc/3L9B-7JGD].

425 Childhood Immunization Support Program, Best Practices, supra note 421.

426 Id. The standard ends with a recommendation that professional encourage patient and parents to report adverse events and additional sources to obtain information that we omitted for brevity.

427 Id.

428 Id.

429 Id.

430 All webpages link to the CDC's VIS home page. See Vaccine Information Statements, supra note 272.

431 Instructions for Using VISs, Ctrs. for Disease Control and Prevention (Apr. 5, 2019), https://www.cdc.gov/vaccines/hcp/vis/about/required-use-instructions.html [https://perma.cc/B4LR-9DD8].

432 Id.

433 The Immunization Action Coalition, Immunization Action Coalition (Sept. 8, 2019), https://www.immunize.org/aboutus [https://perma.cc/Q9UB-A94B].

434 Id.

435 Instructions for Using VISs, supra note 431. The IAC website has translations of VISs into are large number of languages. See Vaccine Information Statements, Immunization Action Coalition (Aug. 27, 2019), https://www.immunize.org/vis [https://perma.cc/V8UT-JD82].

436 You Must Provide Patients with Vaccine Information Statements, Immunization Action Coalition, http://www.immunize.org/catg.d/p2027.pdf [https://perma.cc/B8TL-NQM8].

437 Id. The IAC also has a supplemental document on VISs. Documenting Vaccination, Immunization Action Coalition (Oct. 2, 2019), http://www.immunize.org/askexperts/documenting-vaccination.asp [https://perma.cc/6BFZ-BMKH].

438 Your Child's First Vaccines, Ctrs. for Disease Control and Prevention (Nov. 5, 2015), https://www.immunize.org/vis/multi_vaccine_infants.pdf [https://perma.cc/AG56-W26F].

439 Id.

440 Id. Emphasis in the original.

441 Id.

442 Id.

443 Id.

444 Id. Emphasis in the original.

445 Id.

446 Id.

447 Id.

448 Id. Emphasis in the original.

449 Id. Allergic Reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/index.html (last visited Jan. 8, 2019).

450 Id. The National Vaccine Injury Compensation Program's website is at https://www.hrsa.gov/vaccine-compensation [https://perma.cc/CT7N-WUUE].

451 Id.

452 Id.

453 See Ctrs. for Disease Control and Prevention, DTaP (Diphtheria, Tetanus, Pertussis) Vaccine (Aug. 8, 2018), https://www.immunize.org/vis/dtap.pdf [https://perma.cc/8BREGDJD].

454 It is dated May 17, 2007. Nat'l Ctr. for Immunization and Respiratory Diseases, Vaccine Information Statements for Currently Available Vaccines, Ctrs. for Disease Control and Prevention (April 5, 2019), https://www.cdc.gov/vaccines/hcp/vis/vis-dates.html [https://perma.cc/U4KU-6C54].

455 It is dated February 12, 2018. Id.

456 The current version is dated December 2, 2016. Id.

457 Nat'l Ctr. for Immunization and Respiratory Diseases, DTaP (Diptheria, Tetanus, Pertussis) VIS, Ctrs. for Disease Control and Prevention (April 5, 2019), https://www.cdc.gov/vaccines/hcp/vis/vis-statements/dtap.html [https://perma.cc/F26Q-MSVE] [hereinafter DTaP VIS]; Nat'l Ctr. for Immunization and Respiratory Diseases, MMR (Measles, Mumps, & Rubella) VIS, Ctrs. for Disease Control and Prevention (April 5, 2019), https://www.cdc.gov/vaccines/hcp/vis/vis-statements/mmr.html [https://perma.cc/BDC6-CTXF] [hereinafter MMR VIS]; Nat'l Ctr. for Immunization and Respiratory Diseases, HPV (Human Papillomavirus) VIS, Ctrs. for Disease Control and Prevention (April 5, 2019), https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv.html [https://perma.cc/9P36-77YD] [hereinafter HPV VIS].

458 DTaP VIS, supra note 457.

459 See supra note 457.

460 MMR VIS, supra note 457.

461 Nat'l Ctr. for Immunization and Respiratory Diseases, MMRV (Measles, Mumps, Rubella & Varicella) VIS, Ctrs. for Disease Control and Prevention (Aug. 15, 2019) https://www.cdc.gov/vaccines/hcp/vis/vis-statements/mmrv.html [https://perma.cc/A55H-PU6F].

462 See supra note 457.

463 DTaP VIS, supra note 457 (“DTaP is not licensed for adolescents, adults, or children 7 years of age and older. But older people still need protection. A vaccine called Tdap is similar to DTaP. A single dose of Tdap is recommended for people 11 through 64 years of age. Another vaccine, called Td, protects against tetanus and diphtheria, but not pertussis. It is recommended every 10 years. There are separate Vaccine Information Statements for these vaccines.”).

464 See supra note 457.

465 See supra note 457.

466 HPV VIS, supra note 457.

467 Global Advisory Committee on Vaccine Safety, Safety Update of HPV Vaccines, World Health Org. (Jul. 14, 2017) http://www.who.int/vaccine_safety/committee/topics/hpv/June_2017/en/ [https://perma.cc/8HSP-9WTW].

468 DTaP VIS, supra note 457; MMR VIS, supra note 457.

469 See supra note 457.

470 See supra note 457.

471 The formula followed these guidelines: How to Use the SMOG Readability Formula on Health Literacy Materials, Readability Formulas, http://www.readabilityformulas.com/articles/how-to-use-smog-readability-formulas-on-health-literacy-materials.php [https://perma.cc/PE5D-TNFZ].

472 DTaP VIS, supra note 457.

473 Adam E. M. Eltorai et al., Readability of Invasive Procedure Consent Forms, 8 Clinical and Translational Science 830, 830 (2015).

474 See supra notes 145–149 and accompanying text.

475 Vaccine Information Statements, supra note 272.

476 Your Child's First Vaccines, supra note 438.

477 DTaP (diphtheria, tetanus, pertussis) VIS: Up-to-date translations, Immunization Action Coalition, http://www.immunize.org/vis/vis_dtap.asp [https://perma.cc/78DX-96VQ].

478 The CDC released an interim VIS for the HPV vaccine on October 30, 2019, and an interim VIS for the MMR vaccine on July 15, 2019, so the translations currently available through the Immunization Action Coalition are slightly out of date. “CDC states that it is acceptable to use out-of-date VIS translations since there have not been significant content changes in the interim version compared with the previous VIS.” HPV (Human Papillomavirus) VIS: Out-of-date translations, Immunization Action Coalition, http://www.immunize.org/vis/vis_hpv.asp [https://perma.cc/G2RT-GABP]; MMR (Measles, Mumps, Rubella) VIS: Out-of-date translations, Immunization Action Coalition, http://www.immunize.org/vis/vis_mmr.asp [https://perma.cc/CT4E-K94Y].

479 Nat'l Ctr. for Immunization and Respiratory Diseases, Facts About VISs, Ctrs. for Disease Control and Prevention (April 5, 2019), https://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html [https://perma.cc/5Y73-7WSX] [hereinafter Facts About VISs].

480 Terry C. Davis et al., supra note 46.

481 Childhood Immunization Support Program, supra note 425; see also Facts About VISs, supra note 479.

482 National Vaccine Childhood Injury Act, 42 U.S.C. § 300aa-26 (2012).

483 Terry C. Davis et al., supra note 46.

484 State of Isr., Ministry of Health, Childhood Vaccines, supra note 362.

485 Terry C. Davis et al., supra note 46.

486 42 U.S.C. § 300aa-26 (2012).

487 See supra notes 287–290 and accompanying text.

488 See supra notes 49–50 and accompanying text.

489 Childhood Vaccines (2017), supra note 362.

490 Id.; MMRV Information Sheet, supra note 400.

491 Childhood Vaccines (2017), supra note 362.

492 MMRV Information Sheet, supra note 400.

493 Childhood Vaccines (2017), supra note 362.

494 Id.

495 See, e.g., MMRV Information Sheet, supra note 400.

496 Guide to Vaccines Injection (2014), supra note 333.