Ethics and Vaccination

Transcription

1 Ethics and Vaccination Jason L. Schwartz, Ph.D., MBE Harold T. Shapiro Fellow in Bioethics University Center for Human Values Princeton University New Jersey Immunization Network 18 September 2013

2 Mandatory Vaccination New Jersey,

3 Topics in Vaccine Ethics 1) Ethical Issues in Vaccine Development and Regulation -- Priority-setting -- Research and development; clinical trials -- Risk/benefit assessments, regulation, post-licensure surveillance -- Vaccine recommendations; role of cost-effectiveness data 2) Ethical Issues in Vaccination Programs -- Financing and access -- Education and promotion providers, parents, etc. -- Risk controversies, safety, and compensation programs -- Mandatory vaccination policies children, HCWs, other groups -- Vaccination in the developing world; eradication programs -- Vaccines in pandemic/bioterrorism planning and response 3

4 Outline 1. Vaccine ethics context and general principles 2. Recent topics in vaccine ethics and policy -- Rotavirus vaccines, safety monitoring, and risk-benefit communication -- Non-medical exemptions from state vaccination requirements -- Provider responses to parental vaccine hesitancy and refusal 3. Concluding thoughts 4. Discussion, questions, comments 4

5 Outline 1. Vaccine ethics context and general principles 2. Recent topics in vaccine ethics and policy -- Rotavirus vaccines, safety monitoring, and risk-benefit communication -- Non-medical exemptions from state vaccination requirements -- Provider responses to parental vaccine hesitancy and refusal 3. Concluding thoughts 4. Discussion, questions, comments 5

6 Key Issues for Vaccine Ethics -- Administered to healthy individuals Ethics of prevention vs. ethics of treatment -- Children as primary recipients of most routinely administered vaccines Heightened sensitivity to risk Tradition of government interest and intervention in child well-being -- Herd immunity Individual and community consequences of vaccine acceptance/refusal -- Given to very large percentages of population Rare adverse events more likely to be visible Difficulty distinguishing temporal correlation from causation 6

7 Bioethics and Public Health Ethics Bioethics Focus on individual patient or research subject Rights of patient/subject, obligations of physician/researcher, patient-doctor relationship in treatment decisions Autonomy Public Health Ethics Focus on health of communities and populations Social Justice Vaccination combines elements of both fields 7

8 An Ethical Objective for Vaccination Maximize the net benefits of vaccines in preventing morbidity and mortality in all populations, while Minimizing exposure to severe vaccine-related adverse events, and Minimizing infringements on individual and parental decision-making prerogatives 8

9 Applying Ethical Frameworks and Principles to Vaccine Policy Bioethics Professional Ethics Public Health Ethics Political Philosophy Autonomy Beneficence Nonmaleficence Justice Professional Codes of Ethics (AMA, ANA, etc.) Effectiveness Proportionality Necessity Least Infringement Public Justification Harm Principle (J.S. Mill) And others 9

10 Outline 1. Vaccine ethics context and general principles 2. Recent topics in vaccine ethics and policy -- Rotavirus vaccines, safety monitoring, and risk-benefit communication -- Non-medical exemptions from state vaccination requirements -- Provider responses to parental vaccine hesitancy and refusal 3. Concluding thoughts 4. Discussion, questions, comments 10

11 Recent and Ongoing Vaccine Safety Allegations, Late 1990s-2013 MMR Thimerosal Size/Timing/Spacing of Recommended Schedule Combination Vaccines Aluminum Adjuvant Formaldehyde Foreign DNA Genetically Modified Vaccines 11

12 The First Rotavirus Vaccine RotaShield, Pediatrics, October

13 Intussusception and the July 1999 Suspension of RotaShield Administration MMWR, 16 July

14 CDC Perspective on RotaShield Basing decisions solely on the balance of the mortality or morbidity prevented by vaccination versus the mortality or morbidity caused by vaccination is insufficient. At a time when many parents express concern about the safety of vaccines and vaccine adverse events are the focus of increasing attention by the public, media, and US Congress, the wisdom of recommending a vaccine that causes a severe adverse reaction in an estimated 1 in 10,000 infants must be considered. Murphy, et al. JID 2003:187 14

15 Rotateq, Rotarix, and Intussusception Far larger pre-licensure trials to look for possible association with intussusception (60-70K) Heightened attention to possible association as part of safety surveillance activities Post-licensure, small association identified for both vaccines 15

16 Rotateq, Rotarix, and Intussusception CDC and ACIP: unambiguous statements that benefits of vaccination outweigh risks, June 2013 Estimated excess intussusception cases in one cohort through age 5 (18-88 surgeries; deaths) Estimated 169,949 ED visits prevented, 53,444 admissions, 14 deaths/cohort related to rotavirus Endorse further surveillance and provider/patient education; VIS updated (8/13) Unanswered questions remain, but importance of process -- open deliberation and dissemination of risk-benefit data to providers, parents, and international community. 16

17 Outline 1. Vaccine ethics context and general principles 2. Recent topics in vaccine ethics and policy -- Rotavirus vaccines, safety monitoring, and risk-benefit communication -- Non-medical exemptions from state vaccination requirements -- Provider responses to parental vaccine hesitancy and refusal 3. Concluding thoughts 4. Discussion, questions, comments 17

18 Resistance to Mandatory Vaccination Pennsylvania,

19 Vaccine Mandates, Vaccination Rates, and Health Disparities Morita JY, Ramirez E, Trick WE. Pediatrics 121, 3 (2008) pp. e547-e552 19

20 20

21 State Vaccination Exemption Criteria TYPE OF EXEMPTION(S) ALLOWED Philosophical, Religious & Medical (20) Religious & Medical (29) Medical only (2) Courtesy of Daniel Salmon

22 Are Mandates Really Mandates? Exemptions and their Ethical Implications Re: mandates as infringing upon parental autonomy Procedural steps to obtain exemption Often easier than documenting vaccination Difficult for states to assess sincerity of claimed religious or philosophical beliefs Overall: national non-medical exemption rate ~2-3%, but concern re: communities with higher rates Associations between exemptions and disease outbreaks among individuals and communities 22

23 Exemptions and the Problem of Free-Riders Argument: exemptors are free-riders Enjoy benefits associated with high vaccination rates (e.g., through herd immunity) Don t assume any of the costs/risks of vaccination themselves Self-defeating if too many choose this Risks of exemptors to the vaccinated (and those unable to be vaccinated contraindications/age) Outbreaks among exemptors Transmission to non-exemptors 23

24 The Future of Non-Medical Exemptions Numerous state proposals to make obtaining non-medical exemptions more difficult -- Relationship between difficulty of exemption process and exemption rates -- Ensuring parents understand risks of children remaining unvaccinated Others call for eliminating non-medical exemptions entirely, based on ethical and public health arguments Value of non-medical exemptions as pressure release valve for U.S. vaccine policy 24

25 Prudent Personal Belief Exemption Policies -- Marcuse, Archives of Pediatrics, December 2012: Prohibition policies drove alcohol consumption underground but failed to halt its consumption. Simple opposition to any form of PBEs will likely have the same effect. Well-crafted PBE policies can help to foster dialogue between parents and health care providers and sustain public support for immunization programs and for school entry mandates. 25

26 Outline 1. Vaccine ethics context and general principles 2. Recent topics in vaccine ethics and policy -- Rotavirus vaccines, safety monitoring, and risk-benefit communication -- Non-medical exemptions from state vaccination requirements -- Provider responses to parental vaccine hesitancy and refusal 3. Concluding thoughts 4. Discussion, questions, comments 26

27 Vaccination Hesitancy and Refusal 27

28 Dr. Bob s Alternative Vaccination Schedule 28

29 Responses to Vaccine Hesitancy and Refusal -- Documented Refusal forms (e.g., AAP) -- Providers dismissing children of parents who wish to delay or decline ACIP/AAP recommended vaccines -- Advocates argue: signals importance of on-time vaccination; protects health of other patients (waiting room risks, etc.) -- Critics respond: leaves unvaccinated children without advocacy ( vaccine-friendly physicians); results in clustering of unvaccinated children; ends opportunity for future discussion and changing minds. 29

30 Responses to Vaccine Hesitancy and Refusal Families with doubts about immunization should still have access to good medical care, and maintaining the relationship in the face of disagreement conveys respect and at the same time allows the child access to medical care. Furthermore, a continuing relationship allows additional opportunity to discuss the issue of immunization over time. -- American Academy of Pediatrics (emphasis added) 30

31 Outline 1. Vaccine ethics context and general principles 2. Recent topics in vaccine ethics and policy -- Rotavirus vaccines, safety monitoring, and risk-benefit communication -- Non-medical exemptions from state vaccination requirements -- Provider responses to parental vaccine hesitancy and refusal 3. Concluding thoughts 4. Discussion, questions, comments 31

32 Vaccine Ethics and Policy Looking Ahead -- Increasing attention to aggressive policies intended to ensure high vaccination rates: Limiting or eliminating non-medical exemptions Doctors dismissing patients Mandating HCW influenza vaccination as condition of employment Civil liability for intentionally unvaccinated individuals shown to who -- Even if compelling ethical justifications exist for these policies individually, do they advance vaccination efforts overall? 32

33 Vaccine Ethics and Policy Looking Ahead Importance of public confidence and trust in vaccines, vaccine policy, and vaccine policy-makers Balancing and prioritizing attention directed toward: Vocal, passionate critics of contemporary vaccine policy, and Parents/patients inclined to support vaccination but confused or concerned about aspects of vaccination activities and controversies they hear about Potential disadvantages of making aggressive enforcement policies the face of vaccination activities vs. making the positive case for value of vaccination for individuals and communities (using evidence). 33

34 Outline 1. Vaccine ethics context and general principles 2. Recent topics in vaccine ethics and policy -- Rotavirus vaccines, safety monitoring, and risk-benefit communication -- Non-medical exemptions from state vaccination requirements -- Provider responses to parental vaccine hesitancy and refusal 3. Concluding thoughts 4. Discussion, questions, comments 34

35 Ethics and Vaccination Jason L. Schwartz, Ph.D., MBE Harold T. Shapiro Fellow in Bioethics University Center for Human Values Princeton University New Jersey Immunization Network 18 September 2013