Abstract
Vaccines are a near-integral part of every child’s growing up. Expectedly, each inoculation is a matter of concern and anxiety, notwithstanding the fact that vaccines are by and large safe. Much like commercial flying, a lot needs to go into making the process safe and reliable every time. Global efforts have been on to make vaccines, vaccination, and injection waste safe for all concerned. The Adverse Events Following Immunization (AEFI) surveillance system is a cornerstone of that process. This chapter takes an international perspective in understanding that experience. Developing countries such as India are in the process of setting up surveillance systems and are also a fertile ground for vaccine controversies. The controversies over the pediatric pentavalent vaccine is the most recent such example. Vaccinations are repeated acts making parents prone to hesitancy and in extreme cases frank resistance.
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References
WHO. State of the world’s vaccines and immunization. Geneva: World Health Organization; 2002.
Folb PI, Bernatowska E, Chen R, Clemens J, Dodoo ANO, Ellenberg SS, et al. A global perspective on vaccine safety and public health: the Global Advisory Committee on Vaccine Safety. Am J Public Health. 2004;94(11):1926–31.
WHO. Causality assessment of adverse events following immunization. Wkly Epidemiol Rec. 2001;76:85–92.
Kohl KS, Bonhoeffer J, Braun MM, Chen RT, Duclos P, Heikbel H, et al. The Brighton Collaboration: creating a global standard for case definitions (and guidelines) for adverse events following immunization. In: Henriksen K, Battles JB, Marks ES, Lewin D, editors. Advances in patient safety: from research to implementation, Concepts and methodology, vol. 2. Rockville, MD: Agency for Healthcare Research and Quality; 2005. p. 87–102.
Duclos P, Delo A, Aguado T, Bilous J, Birmingham M, Kieny MP, et al. Immunization safety priority project at the World Health Organization. Semin Pediatr Infect Dis. 2003;14(3):233–9.
Rauh L, Schmidt R. Measles immunization with killed virus vaccine. Am J Dis Child. 1965;109:232–7.
Shui IM, Baggs J, Patel M, Parashar UD, Rett M, Belongia EA, et al. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants. J Am Med Assoc. 2012;307(6):598–604.
Injection safety support. Available at http://www.gavialliance.org/support/nvs/ins/. Accessed 10 Dec 2011.
Staff training and education. Available at http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/vacc_admin.pdf. Accessed 31 Jan 2012.
Global Learning Opportunities for Vaccine Quality. Available at http://www.who.int/immunization_standards/vaccine_quality/gtn_index/en/. Accessed 7 Dec 2011.
WHO Collaborating Centre for International Drug Monitoring. Report from the WHO Collaborating Centre for International Drug Monitoring Activities July 2010–June 2011. Available at www.who-umc.org/graphics/25850.pdf. Accessed 23 Jan 2012.
Labadie J. Postlicensure safety evaluation of human papilloma virus vaccines. Int J Risk Saf Med. 2011;23(2):103–12.
Global vaccine safety blueprint project. Available at http://www.who.int/immunization_safety/activities/GVS_blueprint_project/en/index.html. Accessed 2 Feb 2012.
Who M. Surveillance of adverse events following immunization, field guide 3 for managers of immunization programmes. Geneva: World Health Organization; 1997.
Al Awaidy S, Bawikr S, Prakash KP, Al Rawahi B, Mohammed AJ. Surveillance of adverse events following immunization: 10 years’ experience in Oman. East Mediterr Health J. 2010;16(5):474–80.
Centers for Disease Control and Prevention (CDC). Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)—United States, 1991–2001. Morb Mortal Wkly Rep. 2003;52(1):1–24.
Lawrence G et al. Surveillance of adverse events following immunization in Australia 2004. Commun Dis Intell. 2005;29(3):248–62.
WHO. Supplementary information on vaccine safety, part 2: background rates of adverse events following immunization. Geneva: World Health Organization; 2000.
UNICEF Eastern and Southern Africa Regional Office. Combating anti-vaccination rumors: lessons learned from case studies in East Africa. Available at http://www.path.org/vaccineresources/files/Combatting_Antivac_Rumors_UNICEF.pdf(2003) Accessed 11 Mar 2012.
Gangarosa EJ, Galazka AM, Wolfe CR, Phillips LM, Gangarosa RE, Miller E, et al. Impact of anti-vaccine movements on pertussis control: the untold story. Lancet. 1998;351:356–61.
Kharabsheh S, Al-Otoum H, Clements J, Abbas A, Khuri-Bulos N, Belbesi A, et al. Mass psychogenic illness following tetanus-diphtheria toxoid vaccination in Jordan. Bull World Health Organ. 2001;79(8):764–70.
Bentsi-Enchill AD, Zongo I, Khamassi S, Pless R, Thombiano R, Tiéndrebéogo S, et al. Monitoring of adverse events during the 2003 mass vaccination campaign with a trivalent meningococcal A/C/W135 polysaccharide vaccine in Burkina Faso. Vaccine. 2007;25 Suppl 1:A72–8.
Government of India. AEFI Surveillance and Response: Operational Guidelines. New Delhi, Ministry of Health. 2010.
Simonsen L, Kane A, Lloyd J, Zaffran M, Kane M. Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bull World Health Organ. 1999;77(10):789–800.
IndiaCLEN Programme Evaluation Network. Assessment of injection practices in India (2002-2003). Available at http://www.ipen.org.in/index.php?option=com_content&task=view&id=50&Itemid=48. Accessed 16 Nov 2011.
National Family Health Survey, India; Fact Sheets. Available at http://www.nfhsindia.org/factsheet.html. Accessed 12 Jan 2012.
Government of India. Standard Operating Procedures (SOPs) for Adverse Events Following Immunization. Ministry of Health and Family Welfare, New Delhi. Available at http://www.whoindia.org/LinkFiles/Routine_Immunization_standard_operating_procedures.pdf. Accessed 1 Feb 2012.
Sharma P, Mukherjee R, Talwar GP, Sarathchandra KG, Walia R, Parida SK, et al. Immunoprophylactic effects of the anti-leprosy Mw vaccine in household contacts of leprosy patients: clinical field trials with a follow up of 8-10 years. Lepr Rev. 2005;76:127–43.
Tandon S, Kumar M. Process of a vaccine trial: case of anti-leprosy vaccine. Econ Pol Wkly. 2000;35(8/9):726–35.
Vishwanath K, Kirbat P. Genealogy of a controversy: development of an anti-fertility vaccine. Econ Pol Wkly. 2000;34(8 & 9):718–25.
Richter J. Clinical trials of immunological contraceptives. Available at http://www.finrrage.org/pdf_files/Conference%20Reports/ImmunologicalContraceptives.pdf Accessed 11 Feb 2012.
Hardon A. Contesting claims on the safety and acceptability of anti-fertility vaccines. Reprod Health Matters. 1997;10:68–81.
Bilton T et al. Health, illness and medicine. In: Introductory Sociology. Palgrave Macmillan, Basingstoke, Hampshire, UK; 2004.
Sankaranarayanan R. HPV vaccination: the promise & problem. Indian J Med Res. 2009;130:322–6.
PATH. Statement from PATH: HPV demonstration project in India. Available at http://www.path.org/news/pr110511-hpv-india.php. Accessed 1 Dec 2011.
Jesani A. Policy and global health: how can things change? Available at http://www.nuffieldbioethics.org/sites/default/files/files/Amar_Jesani.pdf. Accessed 21 Jan 2012.
Sarojini NB, Srinivasan S, Madhavi Y, Srinivasan S, Shenoi A. HPV vaccine: science, ethics and regulation. Econ Pol Wkly. 2010;45(27):27–34.
Sarojini N, Shenoi A, Srinivasan S, Jesani A. Undeniable violations, unidentifiable violators. Econ Pol Wkly. 2011;46(24):17–9.
WHO. Expert Panel Report. Report of a WHO ad hoc expert panel to review reports of serious AEFI following administration of pentavalent and other vaccines-Sri Lanka, 23 December 2008.
Lone Z, Puliyel JM. Introducing pentavalent vaccine in the EPI in India: a counsel for caution. Indian J Med Res. 2010;132:1–3.
Subcommittee on Introduction of Hib Vaccine in Universal Immunization Program, National Technical Advisory Group on Immunization, India. NTAGI Subcommittee recommendations on Haemophilus influenzae type b (Hib) vaccine introduction in India. Indian Pediatr. 2009;46:945–54.
John TJ, Muliyil J. Introducing pentavalent vaccine in EPI in India: issues involved. Indian J Med Res. 2010;132:450–5.
Shantha Bio hoping to re-introduce pentavalent vaccine by 2013. Hindu Business Line, 10 Feb 2012.
Jadhav S, Datla M, Kreeftenberg H, Hendriks J. The Developing Countries Vaccine Manufacturers’ Network (DCVMN) is a critical constituency to ensure access to vaccines in developing countries. Vaccine. 2008;26(13):1611–5.
Dyer O. WHO’s attempts to eradicate polio are thwarted in Africa and Asia. Br Med J. 2005;330:1106.
Dasgupta R, Chaturvedi S, Adhish V, Ganguly KK, Rai S, Arora NK, et al. Social determinants for effective implementation of polio eradication program. New Delhi: IndiaCLEN Program Evaluation Network; 2007.
Chaturvedi S, Dasgupta R, Adhish V, Ganguly KK, Sushant L, Srabasti S, et al. Deconstructing social resistance to pulse polio campaign in two North Indian districts. Indian Pediatr. 2009;46:963–74.
Bhattacharya S, Dasgupta R. A tale of two global health programmes: smallpox eradication’s lessons for the antipolio campaign in India. Am J Public Health. 2009;99(7):1176–84.
Arora NK, Chaturvedi S, Dasgupta R. Global lessons from India’s poliomyelitis elimination campaign. Bull World Health Organ. 2010;88:232–4.
Feek W. A drop of tension. J Health Commun. 2010;15(1):3–8.
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Dasgupta, R., Arora, N.K. (2013). An International Perspective on Vaccine Safety. In: Chatterjee, A. (eds) Vaccinophobia and Vaccine Controversies of the 21st Century. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7438-8_23
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