Vaccine Safety and Surveillance for Adverse Events Following Immunization (AEFI) in India
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Rationale: Assured quality vaccines and safe immunization practices are pre-requisite to successful immunization programs. All vaccines go through stringent safety checks during pre-licensure stage. Adverse Events Following Immunization (AEFI) Surveillance program is an integral part of routine immunization program in India to monitor the vaccine safety in the post licensure phase. Indian AEFI Program: National AEFI surveillance relies on passive surveillance and reporting by the health functionaries and practitioners. Vigorous strengthening of AEFI surveillance has resulted in manifold rise in absolute number of AEFI reports across several reporting units in the country in the last decade. Establishment of National AEFI Secretariat, National Technical Collaborating Centre, and development of risk communication strategy as well as quality management certification are some of the unique aspects of this public health program. All serious AEFI reports undergo a systematic causality assessment as per WHO-algorithm by trained committees. National AEFI surveillance system has forged formal linkages with national pharmacovigilance program, the regulators, and professional bodies. Challenges: The number of the reported serious AEFIs are still far less than the expected numbers. Although the AEFI committees at the district and state levels have been established, a large proportion are far from functional. Way forward: As the national immunization program introduces newer vaccines for different age groups and coverage improves, the issues of vaccine hesitancy and confidence are likely to be raised more often and the AEFI surveillance program will have to assume greater responsibility to comprehensively respond to the community concerns and sustain public confidence in vaccines.
KeywordsRoutine immunization program Vaccine safety Vaccine confidence AEFI committee
NKA, JJ and MKD conceptualized the manuscript. JJ and MKD reviewed the literature and drafted the manuscript. DP, SA, MKA and NKA reviewed the manuscript. NKA will act as guarantor for the paper.
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- 1.Centers for Disease Control and Prevention (CDC). Ten great public health achievements- United States, 1900–1999. MMWR Morb Mortal Wkly Rep. 1999;48:241–3. Available at : https://www.cdc.gov/mmwr/pdf/wk/mm6019.pdfDC MMWR. Accessed 2 Apr 2017.
- 2.WHO Immunization, Vaccines and Biologicals. World Immunization Week 2012. Available at : http://www.who.int/immunization/newsroom/events/immunization_week/en/. Accessed 2 Apr 2017.
- 3.CDC MMWR. Recommendations of the international task force for disease eradication. Centre for Disease Control and Prevention, Morbidity and Mortality Weekly Report; 1993;42:1–38. Available at : https://www.cdc.gov/vaccines/parents/vaccine-decision/index.html?s_cid=bb-vaccines-Child-HP03-NCIRD. Accessed 26 July 2017.
- 4.Miller ER, Haber P, Hibbs B, Broder K. Surveillance for adverse events following immunization using the vaccine adverse event reporting system (VAERS). In Roush SW, Baldy LM, editors. VPD surveillance manual, 5th ed. USA: Centre for Disease Control; 2011. p. 1–14. Available at : https://www.cdc.gov/vaccines/pubs/surv-manual/chpt21-surv-adverse-events.pdf. Accessed 2 April 2017.
- 8.Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. Available at: https://doi.org/10.17226/13164. Accessed 2 Apr 2017.
- 10.Anonymous. Retraction-Ileal-lymphoid-nodular hyperplasia, nonspecific colitis, and pervasive developmental disorder in children. Lancet. 2010;375:445. https://doi.org/10.1016/S0140-6736(10)60175-4.
- 12.Giannattasio A, Mariano M, Romano R, et al. Sustained low influenza vaccination in health care workers after H1N1 pandemic: a cross sectional study in an Italian health care setting for at-risk patients. BMC Infect Dis. 2015;15:329–36.Google Scholar
- 13.Jegede AS. What led to the nigerian boycott of the polio vaccination campaign? PLoS Med. 2007;4:0417-22. https://doi.org/10.1371/journal.pmed.0040073
- 15.Media report. WhatsApp rumours about vaccinations hamper India's drive to halt measles and rubella, The government plans to extend the campaign by a week to achieve targets: February 24, 2017. Available at: https://scroll.in/pulse/830129/rumours-about-measles-rubella-vaccine-hit-coverage. Accessed 2 Apr 2017.
- 16.States seek to allay fears over measles-rubella vaccine. January 29, 2017. Available at: http://www.thehindu.com/news/national/States-seek-to-allay-fears-over-measles-rubella-vaccine/article17110296.ece. Accessed 2 Apr 2017.
- 17.Integrated Child Health and Immunization Survey (INCHIS). Report- Rounds 1 & 2. 2016. Immunization technical support unit, Ministry of Health and Family Welfare, Government of India, New Delhi. Available at: http://www.itsu.org.in/integrated-child-health-immunization-survey-inchis-report-rounds-1-2. Accessed 2 Apr 2017.
- 19.WHO. Report Of the Sage working group on vaccine hesitancy. 2014. WHO, Geneva. Available at: http://www.who.int/immunization/sage/meetings/2014/october/1_Report_WORKING_GROUP_vaccine_hesitancy_final.pdf. Accessed 2 Apr 2017.
- 20.National Regulatory Authority of India meets WHO International Standards for Vaccine Regulations, WHO India NRA Press Release. WHO country Office for India, February 21, 2017. Available at: http://www.searo.who.int/india/mediacentre/events/2017/NRA2017/en/. Accessed 2 Apr 2017.
- 21.WHO. Vaccine safety basics: learning manual. 2013, WHO Press, Geneva. Available at: http://www.who.int/vaccine_safety/initiative/tech_support/Vaccine-safety-E-course-manual.pdf?ua=1. Accessed 2 Apr 2017.
- 22.WHO. Global manual on surveillance of adverse events following immunization, 2014. WHO Press, Geneva. Available at: http://www.who.int/vaccine_safety/publications/Global_Manual_on_Surveillance_of_AEFI.pdf. Accessed 2 Apr 2017.
- 23.Operational Guidelines for AEFI Surveillance in India. Revised edition 2011. New Delhi: Ministry of Health and Family Welfare; 2011.Google Scholar
- 24.Operational Guidelines for AEFI Surveillance in India. Revised 2015. New Delhi: Ministry of Health and Family Welfare; 2015.Google Scholar
- 25.WHO. Immunization, vaccines and biologicals. Fact sheets. Available at: http://www.who.int/immunization/newsroom/factsheets/en/. Accessed on July 25th 2017.
- 26.WHO. Causality Assessment of an Adverse Event Following Immunization (AEFI). user manual for the revised WHO classification, 2013. WHO Press. Available at: http://www.who.int/vaccine_safety/publications/aevi_manual.pdf. Accessed 25 July 2017
- 27.Results of causality assessment for reported AEFIs. Ministry of Health and Family Welfare, Government of India. Available at: http://mohfw.nic.in/right-information-rti/rti-act-for-ministry/departments-health-and-family-welfare/immunization. Accessed 25 July 2017.
- 28.Central AEFI Team Investigation Reports. Available at: http://mohfw.nic.in/right-information-rti/rti-act-for-ministry/departments-health-and-family-welfare/immunization/aefi-reports. Accessed 25 July 2017.
- 31.Communication Guidelines for HW for handling AEFIs. Available at: http://mohfw.nic.in/sites/default/files/2013%20Communication%20Guidelines%20for%20Building%20Vaccine%20Confidence%20around%20AEFI.pdf. Accessed 25 July 2017.
- 32.AEFI Media Communication Protocol. Available at: http://www.itsu.org.in/repository-resources/Aefi_media_communication_protocol.pdf. Accessed 25 July 2017.
- 33.Quality Policy for AEFI Surveillance Program. Available at: http://mohfw.nic.in/sites/default/files/AEFI%20Survellance%20Programme-Quality%20Policy%20and%20Objectives.pdf. Accessed 25 July 2017.
- 34.Press Information Bureau. Maximum Possible Marks to India in NRA Assessment. Ministry of Health and Family Welfare, Government of India. February 21, 2017. Available at: http://pib.nic.in/newsite/PrintRelease.aspx?relid=158598. Accessed 2 Apr 2017.
- 35.WHO. Global Vaccine Action Plan 2011-2020. Geneva: WHO Press; 2013. Available at: http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/. Accessed 2 Apr 2017.
- 36.Ministry of Health and Family Welfare, PIB Press Release Mission Indradhanush impact. Available at: http://pib.nic.in/newsite/PrintRelease.aspx?relid=160063. Accessed 25 July 2017.
- 37.New Vaccines in India’s Universal Immunization Program. Available at: http://www.thehindubusinessline.com/economy/policy/four-vaccines-added-to-indias-immunisation-programme/article6173880.ece and PCV introduction http://pib.nic.in/newsite/PrintRelease.aspx?relid=161763. Accessed 25 July 2017.
- 40.Peretti-Watel P, Larson HJ, Ward JK, Schulz WS, Verger P. Vaccine hesitancy: clarifying a theoretical framework for an ambiguous notion. PLOS Curr Outbreaks. 2015. Edition 1. https://doi.org/10.1371/currents.outbreaks.6844c80ff9f5b273f34c91f71b7fc289.
- 41.Global Polio Eradication Initiative. 8th meeting of the independent monitoring board. Wkly Epidemiol Rec. 2013;88:297–300.Google Scholar
- 42.National Family Health Survey – 4, India factsheet (2015–16). International I for Population Sciences. Available at: http://rchiips.org/NFHS/pdf/NFHS4/India.pdf. Accessed 2 Apr 2017.