Hrev_master [Healthcare in Low-resource Settings 2014; 2:2116] [page 53] Hepatitis B vaccine uptake assessment in India Mohan Bairwa Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India Dear Editor, Hepatitis B (Hep B) vaccine was introduced in the Universal Immunization Program (UIP) of 10 States of India in 2007-08. Following Hep B vaccine introduction, Lahariya and col- leagues conducted an assessment of Hep B vaccine debut from August to December 2009 to i) ascertain the reasons for reported low coverage; ii) identify operational and program- matic challenges; and iii) derive lessons for further scale up of Hep B and other newer vac- cine introductions. Two districts, one nearest and other farthermost to State headquarter were selected from five evaluation States [Punjab (PB), Madhya Pradesh (MP), West Bengal (WB), Karnataka (KA) and Tamil Nadu (TN)].1 In the assessment, data were collected through a comprehensive desk review, 143 respondent interviews, a series of cold chain storage observations and immunization site observations of 36 sessions. Lower coverage and higher drop outs were identified of three doses of Hep B vaccine (Hep B3) and three doses of diphtheria, tetanus, and poliomyelitis (DPT) vaccine (DPT3) during the study period. The main reasons behind this were shortage of vaccine, improper or incomplete data recording and reporting, lack of awareness amongst health workers, and not opening of vaccine vials to keep vaccine wastage low. Birth dose administration has been docu- mented in KA, TN and WB of the 5 states included in the assessment. Other two states (PB and TN) concerned about vaccine wastage and adverse events following immunization. The incomplete recording and reporting of the birth dose, along with limited knowledge amongst health care providers about age for Hep B birth dose, was an additional ground behind it. No proper reporting formats were in place to record Hep B vaccine; therefore, it is assumed as equal to respective DPT doses cov- erage by field workers. Amongst 36 session sites visited, the vac- cine stocks and stores were replenished by push mechanism, leading to nil stock position commonly in 56% state and district levels as well as 60% primary health centre level stores. Of the ten private sector paediatricians inter- viewed, three provided Hep B birth dose and five provided coverage reports to the govern- ment. There is no provision to supply routine immunization vaccines to private practitioners by government, which was the reason behind non-reporting of vaccine coverage from private sector. The study documented major lessons were good central and state level oversights, clear policy communications and dissemination of guidelines, quality and timely trainings, effec- tive monitoring and supervision prior and dur- ing early stage of introduction, and improve- ment in recording and reporting. While small sample size and purposive sam- pling were the limitations of the study, state selection according to geographic distribution considering wide geographic, cultural and socioeconomic differences, and comprehen- sive assessment at all levels from field workers to state program managers were the strengths of study. Of the 25 million infants born every year in India, more than 4% live with the lifetime risk of developing chronic Hep B infection. About 4% Indian population were HBsAg positive and over 100,000 Indians die annually because of Hep B-related illnesses.2 Approximately 100 million Hep B carriers live in the member countries of the WHO South-East Asia Region. Despite availability of 95% effective Hep B vac- cine, it was not included in UIP for nearly 2 decades till 2002-03 in selected districts.3 Evaluation of newer health interventions plays a crucial role in improving implementation of health programs at field level, however, it is not commonly practiced in India.4 Most of the program evaluations are neither properly doc- umented nor published in India. The study at stake is a robust evaluation of new vaccine introduction among five major States. The authors report that findings were not only shared with national program managers for immediate corrective measures in early 2010 but also used for further scale up of Hep B vac- cine in all 35 States of India in 2011-12. Two short reviews done in 2004 and 2007 provide assessments of pilot introduction of Hep B vaccination in India; still, the reports were not widely disseminated. This article summarizes and analyses the findings of two previous assessments with the current one and provides comprehensive recommenda- tions and lessons along with limitations of such assessment.1 India has a big private sec- tor for immunization services delivery. However, private sector is assessed in very few program evaluations in India. The private pedi- atricians were included in the present assess- ment which is a refreshing approach and sug- gested consideration of their significant par- ticipation in health programs as well as pro- gram evaluations.The assessment outlined the findings and programmatic lessons including poor stock management, incomplete recording and reporting, perceived high cost and concern towards wastage of vaccine in multi-dose vial, lesser participation of private sector, and poor knowledge of Hep B vaccination schedule amongst healthcare providers. These factors may have been contributed to comparatively low coverage of Hep B vaccine. Later on, the Government of India corrected the majority of issues identified, showing that recommenda- tions based upon robust methodology help in improving program performance. There is a number of vaccine introductions in India since adoption of Hep B vaccine in 10 states of the country. Measles second dose was introduced in 2010; Hep B vaccination scaled up in the entire country in 2011-12, and Haemophilus Influenzae type b (Hib) as pentavalent vaccine was introduced in 2 states in late 2011.5-7 Pentavalent vaccine protects from Hep B along with diphtheria, pertussis, tetanus, and Hib. In Kerala and TN, it has been launched in 2011.8 Majority of lessons from this evaluation con- tributed to planning new vaccine introductions in India. The government of India issued well- defined guidelines, changed policy use of opened vials in subsequent immunization ses- sions, conducted quality trainings prior to the vaccine introduction, and increased supervi- sion and monitoring in vaccine introductions.1 A post-introduction evaluation of pentavalent vaccine introduction in Tamil Nadu and Kerala states documented major experience and noted that the challenges identified in the Hep B vaccine introduction were not present in pentavalent vaccine introduction.9 The pentavalent vaccine has been further scaled up to Gujarat, Haryana, Karnataka, Goa, Jammu, Kashmir and Puducherry in 2012-13 and there is plan for countrywide roll out in 2014.8 Similarly, India has developed an indigenous rotavirus vaccine, which is likely to Healthcare in Low-resource Settings 2014; volume 2:2116 Correspondence: Mohan Bairwa, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi 110029, India. Tel: +91.97188.35447. E-mail: drmohanbairwa@gmail.com Key words: hepatitis B vaccine, health program, newer health interventions. Note: the opinions expressed by the author do not necessarily reflect the opinions of the All India Institute of Medical Sciences, New Delhi, India. Received for publication: 25 December 2013. Revision received: 12 August 2014. Accepted for publication: 26 September 2014. This work is licensed under a Creative Commons Attribution 3.0 License (by-nc 3.0). ©Copyright M. Bairwa, 2014 Licensee PAGEPress, Italy Healthcare in Low-resource Settings 2014; 2:2116 doi:10.4081/hls.2014.2116 No n c om me rci al us e o nly [page 54] [Healthcare in Low-resource Settings 2014; 2:2116] be considered for possible introduction in Indian UIP. A number of states in India plan to introduce the vaccine in their state immuniza- tion programs.10 Thus, such evaluation may help in widely spreading programmatic bene- fits and improving program performance in India. Vaccine introductions are not that differ- ent from the introduction of other health inter- ventions. India aims to achieve Millennium Development Goal 4 and national goals of reducing child mortality and a number of new initiatives are being already implemented and planned for improving child survival in India, under the National Rural Health Mission (NRHM).11 The lessons from this evaluation are potential for being used for scale up of other health interventions. One of the major challenges in health pro- grams in India is the limited focus on evalua- tions and correctives measures. However, the scenario is apparently changing now and num- bers of evaluations are being conducted including common review missions in NRHM.12,13 The robust evaluation used for pro- grammatic corrections is likely to benefit pro- gram implementation in the country and show health impact. References 1. Lahariya C, Subramanya BP, Sosler S. An assessment of hepatitis B vaccine intro- duction in India: lessons for roll out and scale up of new vaccines in immunization programs. Indian J Public Health 2013;57: 8-14. 2. Verma R, Khanna P, Prinja S, et al. Hepatitis B vaccine in national immuniza- tion schedule: a preventive step in India. Hum Vaccines 2011;7:1387-8. 3. Government of India. Operational guide- lines for Hepatitis B introduction in UIP in India, 2009. New Delhi: Ministry of Health and Family Welfare, Government of India; 2009. 4. Dandona L, Raban MZ, Dandona R. Analysis of evaluations of health system/policy interventions in India. Natl Med J India 2011;24:263-8. 5. Gupta SK, Sosler S, Lahariya C. Introduction of Haemophilus influenzae type b as liquid pentavalent (DPT+HepB+Hib) vaccine in 2 States of India. Indian Pediatr 2012;49:707-9. 6. Verma R, Khanna P, Bairwa M, et al. Introduction of a second dose of measles in national immunization program in India: a major step towards eradication. Hum Vaccines 2011;7:1109-11. 7. Gupta SK, Sosler S, Haldar P, et al. Introduction strategy of a second dose measles containing vaccine in India. Indian Pediatr 2011;48:379-82. 8. Bairwa M, Pilania M, Rajput M, et al. Pentavalent vaccine: a major break- through in India’s universal immunization programme. Hum Vaccines 2012;8:1314-6. 9. WHO. Post introduction evaluation of pen- tavalent (DPT+HepB+Hib) vaccine in Tamil Nadu and Kerala, India, report 2012. New Delhi: World Health Organization Country Office for India Publ.; 2013. 10. Government of India. Press information bureau note on indigenous rotavirus vac- cine in India. New Delhi: Government of India Publ.; 2013. 11. Government of India. National rural health mission. Available from: www.nrhm.gov.in 12. Government of India. Sixth common review mission of NRHM. Available from: http://nrhm.gov.in/monitoring/common- review-mission/6th-common-review-mis- sion-crm.html 13. Lahariya C, Dhawan J, Pandey RM, et al. Inter-district variations in child health sta- tus and health services utilization: lessons for health sector priority setting and plan- ning from a cross-sectional survey in rural India. Natl Med J India 2012;25:137-41. Letter to the Editor No n c om me rci al us e o nly