Transitioning Immunization Into the Health Care System: Strengthening Routine Immunization in India

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Introduction

India has the largest birth cohort in the world (27 million children) but lags other countries of similar gross national income per capita on immunization coverage ( Exhibit 25.1 ). A third of the world’s roughly 27 million unimmunized children live in India. The proportion of children under 2 years of age who are fully immunized has increased by 1% a year and is estimated at 64% nationally, based on the latest Annual Health Survey. Coverage varies significantly, from 45% in Uttar Pradesh, a poorly performing large state, to more than 85% in Kerala and Telangana. Although rural India has traditionally lagged urban India in vaccination, recent evidence suggests that for most states, the rural–urban coverage gap is closing, possibly because of the National Rural Health Mission.

The past 3 years have seen significant change in the routine immunization program along three dimensions—system strengthening, coverage improvement, and introduction of new vaccines. Here we report on these improvements and the lessons learnt by the Immunization Technical Support Unit (ITSU), a public–private partnership established to assist the Universal Immunization Programme (UIP).

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Background: India’s Universal Immunization Programme

The Expanded Programme on Immunization was launched in India in Jan. 1978 to reduce mortality and morbidity from vaccine-preventable diseases. Gradually, over the next few years, newer vaccines such as the tetanus toxoid vaccine for pregnant mothers, the polio vaccine, and the measles vaccine were added. As a signatory to the UNICEF declaration on the occasion of the United Nation’s 40th anniversary, India launched the UIP in Oct. 1985. The UIP’s goal was to extend immunization services to cover 85% of all children and 100% of pregnant women by 1990. Yet nearly two decades later, full immunization in India has reached only 64%. In contrast, Bangladesh and Nepal have achieved coverage rates of routine immunization of 80% or more.

The UIP has suffered from several challenges over the years. Foremost was a severe human resource deficit, both in quantity and quality. The immunization cells at both national and state levels were poorly staffed and lack adequately trained personnel. The program also needed strengthening and reevaluation in tracking coverage, monitoring and evaluation, estimating vaccine demand, vaccine logistics, and preventing and handling adverse events following immunization.

However, the program has had important successes, notably the elimination of polio in 2012 and maternal and neonatal tetanus in 2014. The Pulse Polio program, which was coordinated by the World Health Organization’s National Polio Surveillance Programme, was funded entirely by the Ministry of Health and Family Welfare (MoHFW) of the Government of India, and in 1990–2010, the budget allocated to polio was nearly twice what was spent on routine immunization. The success against polio has made it possible to raise political awareness about immunization and confidence in the health system, both at the center and in the states. Although many had predicted that India would be the last country to eliminate polio, the Indian experience is now an exemplar of how to run and maintain a high-quality immunization and surveillance effort. However, the campaign strategy to tackle polio came at the cost of building ongoing systems to deliver routine vaccines and is poorly suited to an effort in which front-line health workers must track immunizations and deliver them every week without high-intensity demand generation and community mobilization.

The list of antigens covered by the UIP has remained largely unchanged since it was introduced in 1985, including BCG, inactivated polio vaccine (IPV)/oral polio vaccine (OPV), DPT, MMR, and rotavirus. The only two additions since 1985 were antigens to protect against hepatitis B and Haemophilus influenzae type b (Hib), introduced as part of the pentavalent vaccine (which also covers diphtheria, pertussis, and tetanus) in 2011 and now being scaled up nationwide in a phased manner.

Cold chain capacity has been a challenge as well. The basic infrastructure for the procurement, supply, and delivery of vaccines in the UIP system has been largely unchanged in 25 years. Cold chain infrastructure and logistics management capacity are limited in many states, even for routine UIP vaccines. Despite systematic efforts to identify gaps and address vaccine logistics management, problems persist. Vaccine logistics are a particular challenge in a large program like the UIP. There are no data systems with information on the quantity of vaccines kept in the 27,000 cold chain points across the country or the temperature at which vaccines are stored. Freezing is a persistent problem. A recent study reported that at state and regional vaccine stores, 11% and 26% of the test boxes were exposed to subzero temperatures, respectively. The percentages were greater for peripheral stores and during transportation, indicating that maintaining vaccine temperatures remains a challenge. Freezing of a vaccine can lead to loss of potency and cause lower immunogenicity and greater likelihood of local reactions.

As part of the effort to address these challenges, ITSU was launched in 2012, designated the “Year of Strengthening Routine Immunization” by the Government of India. ITSU began as a partnership involving MoHFW, the Public Health Foundation of India, and the Bill & Melinda Gates Foundation. Its objectives were to strengthen UIP efforts to improve routine immunization coverage by providing support and technical assistance in the following areas: human resources, monitoring and evaluation and data support, cold chain and vaccine logistics management, bringing evidence to inform policy, and strategic planning and coordination and strategic communications. In 2013, ITSU was designated as an arm of the MoHFW and tasked with providing the technical and management expertise required to design, create, implement, and institutionalize a stronger immunization program. ITSU also serves as an in-house think tank and strategic planning unit at MoHFW to innovate, demonstrate, and document best practices to the states for further scale-up and oversee the full execution of program improvement measures, using program management best practices rooted in a sustainability strategy. The 60-plus staff at ITSU have augmented the limited technical capacity at the UIP.