Microsoft Word - 2. Research drug Article-Nurunnabi et al.-BJB Bangladesh Journal of Bioethics 2018; 9(3): 11-15 11 Mass Vaccination Programme: Public Health Success and Ethical Issues – Bangladesh Perspective Abu Sadat Mohammad Nurunnabi1, Miliva Mozaffor2, Mohammad Akram Hossain3, Sadia Akther Sony4 1. Internationally Trained Medical Doctors (ITMD) Bridging Program, The G. Raymond Chang School of Continuing Education, Ryerson University, Toronto, ON, Canada. Email: abu.nurunnabi@ryerson.ca (corresponding author) 2. Clinician Researcher, Biomedical Research Foundation (BRF), Dhaka, & Laboratory Consultant and Lecturer, Department of Biochemistry, Medical College for Women & Hospital, Uttara, Dhaka-1230, Bangladesh. 3. Professor and Head, Department of Microbiology and Mycology, National Institute of Preventive and Social Medicine (NIPSOM), Dhaka-1212, Bangladesh. 4. Program Manager, Department of Public Health and Informatics, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka-1000, Bangladesh. Abstract: Vaccines are responsible for many global public health successes, such as the eradication of smallpox and significant reductions in other serious infections like diphtheria, pertussis, tetanus, polio and measles. However, mass vaccination has also been the subject of various ethical controversies for decades. Several factors need to be considered before any vaccine is deployed at national programme like the potential burden of disease in the country or region, the duration of the protection conferred, herd immunity in addition to individual protection, vaccine-related risks, financing and the logistical feasibility of the large-scale vaccination. Moreover, several ethical dilemmas revolve around authority and mandates for vaccination, informed consent, benefits vs. risks, and disparities in access to vaccination. This review paper aims to elaborate the ethical issues involved in mass vaccination programme and present some additional challenges in the context of a resource-poor settings of public health in Bangladesh. Keywords: Ethical issues, vaccine, mass vaccination, immunization, EPI, public health, Bangladesh. Introduction: The invention of the vaccine is unarguably one of the greatest medical achievements in the past century. Vaccines have saved millions of lives, prevented significant morbidity and suffering, and even eradicated smallpox and significantly reduced other serious infections like diphtheria, pertussis, tetanus, polio and measles around the globe1. For an example, measles deaths decreased by 60% worldwide between 1999 and 2005, and polio, although missing the goal of eradication by 2005, has decreased significantly as there were fewer than 2,000 cases in 20062. Vaccines have become readily available in most parts of the world, yet debates continue as to the appropriateness of requirements for mass vaccinations, including legal mandates of vaccinations in public health practice and public health emergencies and more routinely Bangladesh Journal of Bioethics 2018; 9(3): 11-15 12 for school entry3. Vaccine ethics can be conceptualized as a set of issues at the intersection of public health policy, clinical ethics, and professional ethics4,5. Several factors need to be considered before any vaccine is deployed at national programme like the potential burden of disease, the duration of the protection conferred, herd immunity in addition to individual protection, vaccine-related risks, cost, and the logistical feasibility of the large-scale vaccination5. Moreover, several ethical and value-based debates revolve around authority and mandates for vaccination, informed consent, benefits vs. risks, and disparities in access to vaccination4. This review paper aims to elaborate those ethical issues involved in mass vaccination programme and present some of the additional challenges in the context of a resource-poor settings of public health sector in Bangladesh. Expanded Programme on Immunization (EPI) in Bangladesh: The World Health Organization (WHO) initiated the Expanded Programme on Immunization (EPI) in May 1974 with the objective to vaccinate children throughout the world. Ten years later, in 1984, the WHO established a standardized vaccination schedule for the original EPI vaccines for six serious infectious and fatal diseases: Bacillus Calmette-Guérin (BCG) for tuberculosis, DPT for diphtheria, pertussis and tetanus, oral polio vaccine (OPV) for polio myelitis, and measles for measles6. Since EPI was launched in Bangladesh on 7th April of 1979, in 1999, the Global Alliance for Vaccines and Immunization (GAVI) was created with the sole purpose of improving child health in the poorest countries by extending the reach of the EPI. The GAVI brought together a grand coalition, including the UN agencies and institutions (WHO, UNICEF, the World Bank), public health institutes, donors and implementing countries, the Bill and Melinda Gates Foundation and The Rockefeller Foundation, the vaccine industry, non- governmental organizations (NGOs) to accomplish the mission7. The creation of the GAVI has helped to renew interest and maintain the importance of immunizations in battling the world’s large burden of infectious diseases7. Some important update on EPI8: i) TT5 dose for WCBA started in 1993, ii) HepB vaccine introduced in 2003, iii) AD syringes introduced in 2004, iv) Pentavalent vaccine introduced in 2009, v) MR vaccine and measles vaccine second dose introduced in 2012, vi) PCV introduced in 2015, vii) tOPV to bOPV switched on 23 April 2016 and IPV to fIPV switched on November 2017, viii) HPV demonstration projects launched on 16 April 2016 in 4 upazillas and 1 zone under Gazipur district which is being completed in 2017, ix) TT switched to Td on March 2019. As a result of outstanding performance in improving the child immunization status, Bangladesh achieved GAVI Alliance Award in 2009 and 2012, which is given as a recognition to achieving the Millennium Development Goals (MDG), particularly in reducing child mortality9. Other mass vaccination programmes: There are several special mass vaccination programme launched and done through EPI Bangladesh Journal of Bioethics 2018; 9(3): 11-15 13 authority. Recently, the Human Papilloma Virus (HPV) vaccine has been introduced for the first time in Bangladesh in 2016 by the Ministry of Health and Family Welfare (MOHFW), with support from the GAVI10. This programme has run in a pilot basis for two years in Gazipur district and as it has become successful. Then the GAVI has become interested to provide support for national introduction of HPV vaccine soon10. Moreover, several mass vaccination programmes are arranged yearly, e.g. special measles campaign, mass vaccination in disaster and during humanitarian crisis, e.g. in Rohingya refugee camps, etc.8, as per decision of the Ministry of Health and Family Welfare, Government of the people’s Republic of Bangladesh. Ethical issues in mass vaccination: In spite of demonstration of individual and collective benefit and cost effectiveness of vaccination, one of the contemporary challenges in providing medical care for children is the increasing proportion of vaccination refusal, especially in the Western world11; however, vaccination rates in developing countries like Bangladesh are very impressive9. It is not a surprise that parents’ refusal to vaccinate their children can cause collective harm by raising unprotected, susceptible individuals in the community. Besides, with herd immunity compromised, devastating disease outbreaks may occur. In these settings, individuals are morally obligated to accept vaccination to prevent harm to others12. Apart from this, in a specific humanitarian crisis or in disaster, failure to provide a vaccine violates the principle of non-maleficence5. Moreover, only vaccines having proven effectivity and safety are to be considered for mass administration5. Such vaccines confer additional benefit through herd immunity apart from protecting people against specific diseases when administered on a large scale5,11. Looking at a long term investment in health care, the statistics illustrate the benefits and economics of vaccines and disease eradication. For an example, smallpox eradication has saved millions of lives over the decades, and millions of dollars in terms of quarantine and treatment13. From a human rights perspective, vaccination equitably promotes and protects public health which satisfy the notion of the Article 25 of the Universal Declaration of Human Rights as stated: “Everyone has the right to a standard of living adequate for the health and well-being of himself and his family … … … by progressive measures, national and international, to secure [its] universal and effective recognition.”5 However, access to vaccination is still not achievable universally. Racial or ethnic disparities in immunization programme is an ethical concern4,5,13. For example, in the United States, Blacks and Hispanics were significantly less likely to report receipt of nearly all preventive services like vaccination12,13. Even a few years back, immunization coverage in the hilly regions and some areas of our country (hard to reach areas) was below national average8. However, we could overcome the situation in a very short time. A new round of polarizing debates started up with the steps taken to make the HPV vaccine mandatory. Some religious conservatives were worried with the programme and they thought that the Bangladesh Journal of Bioethics 2018; 9(3): 11-15 14 availability of a vaccine against a sexually transmitted disease would threaten abstinence-based prevention messages before the vaccine was licensed, this concern created argument for the vaccine10,14. Abstinence is one of the approaches to HIV prevention taken by the Physicians’ organizations. Preventive measures include abstinence- based prevention massages like counseling adolescents and their families for being more responsible on sexual decision making including abstinence13,15. Some religious conservatives thought that the availability of the vaccine could affect the promotion of these messages10,13. Some advocacy groups agreed availability of the vaccines in public health systems; however, they did not agree on making the vaccine mandatory4,10,12,13. Their perspective was this decision of the state may lead to force a child to undergo an intervention that may be incompatible with her family’s religious values and beliefs15. The huge expense of vaccines starting from research to introduce a successful product in the market along with maintenance of its safety and efficacy is a debatable concern in public health in terms cost – as most of the developing countries have some other priorities like pure water supply or sanitation13. Moreover, just as a vaccine that works in one population might not be as effective in another population, so might adverse effects of a vaccine be specific to one population13. This raises another concern about hidden exploitation by the vaccine manufacturers. Once again, parental attitudes and concerns, as most parents expressed the desire for more information about the vaccine before they agree to vaccinate their children, is an essential topic to address16. Physicians and health authority should discuss openly and transparently about necessity of vaccination with parents – as the ultimate decision should be taken by their parents to ensure parental autonomy17,18. However, where the threat of widespread, serious infectious disease is imminent, individual liberties may be justifiably curtailed5,19. In such situation, national health authorities are morally obligated to do all that they reasonably can to implement evidence-based guidelines to avert preventable harm13,15. Conclusion: The benefits of vaccination extend beyond prevention of specific diseases in individuals. Vaccination makes good economic sense, as well as meets the need to care for the weakest members of societies. There may be situations where there is an ethically valid public health justification for restricting individual rights – both in circumstances where such actions benefit the community and in situations where the actions only benefit the individual. However, restrictions should only be placed after meeting certain conditions to ensure judicious use of this power. We conclude that a comprehensive vaccination programme is a cornerstone of good public health and will reduce inequities and poverty especially in a developing country like Bangladesh. References: 1. Andre FE, Booy R, Bock HL, Clemens J, Datta SK, John TJ, et al. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008;86(2):140-146. Bangladesh Journal of Bioethics 2018; 9(3): 11-15 15 2. Greenwood B. The contribution of vaccination to global health: past, present and future. Philos Trans R Soc Lond B Biol Sci. 2014;369(1645):20130433. 3. Amin ANE, Parra MT, Kim-Farley R, Fielding JE. Ethical issues concerning vaccination requirements. Public Health Rev. 2012;34:14. 4. Isaacs D. An ethical framework for public health immunisation programs. NSW Public Health Bull. 2012;23(5-6):111-115. 5. Moodley K, Hardie K, Selgelid MJ, Waldman RJ, Strebel P, Rees H, et al. Ethical considerations for vaccination programmes in acute humanitarian emergencies. Bull World Health Organ. 2013;91(4):290-297. 6. Hadler S, Cochi S, Bilous J, Cutts F. Vaccination Programs in Developing Countries. Chapter 55: Vaccines, 4th ed. Philadelphia: Elsevier; 2004. 7. Global Alliance for Vaccines and Immunizations (GAVI). Global immunization challenges [Internet]. Accessed May 15, 2018. Retrieved from: http://www.vaccinealliance.org/reference/globali mmchallenges.html 8. World Health Organization (WHO). HPV vaccine introduced in Bangladesh WHO South-East Asia Regional Office. 2017. [Internet]. Accessed May 16, 2018. Retrieved from: http://www.searo.who.int/bangladesh/HPVvacci nelaunch/en/ 9. Directorate General of Health Services (DGHS). Bangladesh EPI Coverage Evaluation Survey 2013. Dhaka: Expanded Programme on Immunization, DGHS; 2013:33. 10. Haseen F, Sony SA. Cervical cancer and ethical issues in HPV vaccination. Bangladesh J Bioethics. 2017;8(2):31-37. 11. Salmon DA, Omer SB. Individual freedoms versus collective responsibility: immunization decision making in the face of occasionally repeating values. Emerg Themes Epidemiol. 2006;3(1):1-3. 12. Dawson A. Vaccination and the prevention problem. Bioethics. 2004;18(6):515-530. 13. Ulmer JB, Liu MA. Ethical issues for vaccines and immunization. Nat Rev Immunol. 2002;2(4):291-296. 14. Salmon DA, Haber M, Gangarosa EJ, Phillips L, Smith N, Chen RT. Health consequences of religious and philosophical exemptions from immunization laws: individual and societal risks of measles. JAMA. 1999, 282(1):47-53. 15. Jacobs AJ, Arora KS. When may government interfere with religious practices to protect the health and safety of children? Ethics Med Public Health. 2018;5:86-93. 16. Holman DM, Benard V, Roland KB, Watson M, Liddon N, Stokley S. Barriers to human papillomavirus vaccination among US adolescents: a systematic review of the literature. JAMA Pediatrics. 2014;168(1):76-82. 17. Feikin DR, Lezotte DC, Hamman RF, Salmon DA, Chen RT, Hoffman RE. Individual and community risks of measles and pertussis associated with personal exemptions to immunization. JAMA. 2000;284(24):3145-3150. 18. Leask J, Kinnersley P, Jackson C, Cheater F, Bedford H, Rowles G. Communicating with parents about vaccination: a framework for health professionals. BMC Pediatr. 2012;12:154. 19. Gostin LO. Influenza A(H1N1) and pandemic preparedness under the rule of international law. JAMA. 2009;301(22):2376-2378. Author contributions: ASM Nurunnabi and M Mozaffor were involved in concept and design of the paper; ASM Nurunnabi, M Mozaffor, MA Hossain and SA Sony were equally involved in the literature search, review, compilation, manuscript writing and revision. Conflict of interest: There is no conflict of interest relevant to this paper to disclose.