Immunization in India: Past, Present, and FutureCHAPTER 1

Successful immunization strategy for the country goes beyond vaccine coverage in that self-reliance in vaccine production, creating epidemiological database for infectious diseases and developing surveillance system are also integral parts of the system. It is apparent that the present strategy focuses on mere vaccine coverage.2

4The history of vaccine research and production in India is almost as old as the history of vaccines themselves. During the latter half of the 19th century, when institutions for vaccine development and production were taking root in the Western world, the British rulers in India promoted research and established about 15 vaccine institutes beginning in the 1890s. Prior to the establishment of these institutions, there were no dedicated organizations for medical research in India. Haffkine's development of the world's first plague vaccine in 1897 (which he developed at the Plague Laboratory, Mumbai, India, later named the Haffkine Institute) and Manson's development of an indigenous Cholera vaccine at Kolkata during the same period bear testimony to the benefits of the early institutionalization of vaccine research and development in India. Soon, Indian vaccine institutes were also producing tetanus toxoid (TT), diphtheria toxoid (DT), and diphtheria, pertussis, and tetanus toxoid (DPT). By the time Indians inherited the leadership of the above institutions in the early 20th century, research and technological innovations were sidelined as demands for routine vaccine production took priority. However, after independence, it took three decades for India to articulate its first official policy for childhood vaccination, a policy that was in alignment with the WHO's policy of “Health for All by 2000” (famously announced in 1978 at Alma Atta, Kazakhstan). The WHO's policy recommended universal immunization of all children to reduce child mortality under its Expanded Programme of Immunization (EPI).

In line with Health for All by 2000, in 1978 India introduced six childhood vaccines [Bacillus Calmette-Guérin (BCG), TT, DPT, DT, polio, and typhoid] in its EPI. Measles vaccine was added much later, in 1985, when the Indian government launched the Universal Immunization Programme (UIP) and a mission to achieve immunization coverage of all children and pregnant women by the 1990s. Even though successive governments have adopted self-reliance in vaccine technology and self-sufficiency in vaccine production as policy objectives in theory, the growing gap between demand and supply meant that in practice, India had to increasingly resort to imports. In fact, Government of India had withdrawn indigenous production facilities for oral polio vaccine (OPV) that existed earlier in Coonoor, Tamil Nadu and at Haffkine Institute in Mumbai for trivial reasons. At Coonoor after making several 5batches of good quality OPV, one batch of OPV had failed to pass the neurovirulence test. This happens with all manufacturers, and if a facility has to be closed down for such reason there would have been no OPV in the world today. Thus, OPV has been imported in India for last several years. Similarly, decision of production of inactivated polio vaccine (IPV) in the country was revoked more than two decades ago for no known reasons. Many vaccine manufacturing units have suspended production or closing down in recent years for minor reasons. One wonders who is benefitting by the closure of facilities for manufacturing vaccines in public sector.

The vaccination coverage at present with EPI vaccines is far from complete despite the long-standing commitment to universal coverage. Though the reported vaccination coverage has always been higher than evaluated coverage, the average vaccination coverage has shown a consistent increase over the last two decades as shown in Figure 1. While gains in coverage proved to be rapid throughout the 1980s, taking off from a below 20% coverage to about 60% coverage for some vaccine-preventable diseases (VPDs), subsequent gains have been limited (Fig. 1).

7In CES 2009, the reasons for poor immunization coverage have been found to be: did not feel the need (28.2%), not knowing about vaccines (26.3%), not knowing where to go for vaccination (10.8%), time not convenient (8.9%), fear of side effects (8.1%), do not have time (6%), wrong advice by someone (3%), cannot afford cost (1.2%), vaccine not available (6.2%), place not convenient (3.8%), auxiliary nurse midwife (ANM) absent (3.9%), long waiting time (2.1%), place too far (2.1%), services not available (2.1%), and others (11.8%).²

An urgent need at present is to strengthen routine immunization coverage in the country with EPI vaccines. India is self-sufficient in production of vaccines used in UIP. As such the availability of the vaccine is not an issue. For improving coverage, immunization needs to be brought closer to the communities. There is need to improve immunization practices at fixed sites along with better monitoring and supervision. Effective behavior change communication would increase the demand for vaccination. There is certainly a need for introducing innovative methods and practices. In Bihar, “Muskan ek Abhiyan” an innovative initiative started in 2007 is a good example, where a partnership of government organization, agencies, and highly motivated social workers has paid rich dividends. Full vaccination coverage, a mere 19% in 2005 but zoomed to 49% in 2009.⁴

Globally, new vaccines have been introduced with significant results, including the first vaccine to help prevent liver cancer, hepatitis B vaccine, which is now routinely given to infants in many countries. Rapid progress in the development of new vaccines means protection being available against a wider range of serious infectious diseases. There is a pressing need to introduce more vaccines in EPI. The last couple of decades have seen the advent of many new vaccines in the private Indian market. In fact, most vaccines available in the developed world are available in India. However, most of these vaccines are at present accessible only to those who can afford to pay for them. Paradoxically, these vaccines are most often required by those that cannot afford them. Government of India has included many new vaccines in last decade. This includes birth dose of hepatitis B, pentavalent vaccine, measles, mumps, and rubella (MMR) in place of measles vaccine at 9 months and of late rota virus vaccine and pneumococcal vaccines in selected states in phased manner.8

India, along with ten other WHO South East Asia Region member countries, have resolved to eliminate measles and control rubella/congenital rubella syndrome (CRS) by 2020. In this direction, Ministry of Health & Family Welfare has initiated measles-rubella (MR) vaccination campaign in the age group of 9 months to less than 15 years in a phased manner across the nation. The campaign aims to cover approximately 41 crore children. Expanding coverage with these vaccines and introducing new vaccines which are cost effective in the Indian scenario are required. In 1995, following the Global Polio Eradication Initiative of the WHO (1988), India launched Pulse Polio immunization program with Universal Immunization Program which aimed at 100% coverage. Both Oral Polio Vaccine (OPV) and IPV are administered as part of the National Immunization Schedule. While OPV continues to be administered at birth (0 dose), then at 6, 10, and 14 weeks; fractional dose of IPV is administered at 6 and 14 weeks. In due course, OPV will be phased out completely, and only IPV will be administered (either as a standalone vaccine, or as part of a multivalent vaccine). Introduction of monovalent and bivalent OPV into the polio eradication strategy has shown dramatic results with no polio cases being reported since 13 January 2011. Second dose of MR is also introduced at 16–24 months of age. Several areas in the national immunization program need a revamp. Vaccine production by indigenous manufacturers needs to be encouraged to bring down the costs, reduce dependence on imports, and ensure availability of vaccines specifically needed by India (e.g. typhoid) and custom made to Indian requirements (rotavirus and pneumococcal vaccines). The recent vaccination-related deaths signal a need for improving immunization safety and accountability and strengthening of an adverse event following immunization (AEFI) monitoring system. Finally setting up a system for monitoring the incidence of vaccine preventable diseases and conducting appropriate epidemiological studies is necessary to make evidence-based decisions on incorporation of vaccines in the national schedule and study impact of vaccines on disease incidence, serotype replacement, epidemiologic shift, etc. Several of the above mentioned issues have been addressed by National Vaccine Policy⁵ and mechanism such as National Technical Advisory Group on Immunization (NTAGI) is 9likely to facilitate evidence-based decisions on new vaccines. Global Vaccine Action Plan (GVAP)⁶ signed by 144 member countries of the WHO has also given a call to achieve the decade of vaccines vision by delivering universal access to immunization. The GVAP mission is to improve health by extending by 2020 and beyond the full benefits of immunization to all people, regardless of where they are born, who they are or where they live. It has also called for development and introduction of new and improved vaccines and technologies.

Immunization is considered among the most cost-effective of health investments. In the United States, cost-benefit analysis indicates that every dollar invested in a vaccine dose saves US $2 to US $27 in health expenses.⁷ There has been improvement in last few years: introduction of newer antigens in UIP (hepatitis B, second dose of measles, Japanese encephalitis, and pentavalent vaccine in many states), framing of National Vaccine Policy, support to indigenous vaccine industry, and acknowledging the need to intensify routine immunization (RI) are steps in right direction.⁸ We now need to step up our efforts to strengthen all components of UIP (vaccination schedule, delivery and monitoring, and VPD/AEFI surveillance), overcome all barriers (geographical, politico-social, and technical) and invest heavily in research and development (R&D) to achieve immunization's full potential and a healthier nation.

The other additions in UIP through the way are IPV, rotavirus vaccine (RVV), and measles-rubella (MR) vaccine. Four new vaccines 10have been introduced into the country's UIP, including injectable polio vaccine, an adult vaccine against Japanese encephalitis and pneumococcal conjugate vaccine (PCV).

Vaccines against rotavirus, rubella, and polio (injectable) will help the country meet its millennium development goals four targets that include reducing child mortality by two-thirds by 2015, besides meeting meet global polio eradication targets. An adult vaccine against Japanese encephalitis will also be introduced in districts with high levels of the disease. The recommendations to introduce these new vaccines have been made after numerous scientific studies and comprehensive deliberations by the NTAGI, the country's apex scientific advisory body on immunization.

Pneumococcal conjugate vaccine protects children against severe forms of pneumococcal disease, such as pneumonia and meningitis. Currently, the vaccine is being rolled out to approximately 21 lakh children in Himachal Pradesh and parts of Bihar and Uttar Pradesh in the first phase. This will be followed by introduction in Madhya Pradesh and Rajasthan next year, and eventually be expanded to the country in a phased manner.

Out of all the causes of diarrhea, rotavirus is a leading cause of diarrhea in children less than 5 years of age. It is estimated that rotavirus cause 872,000 hospitalizations; 3,270,000 outpatient visits and estimated 78,000 deaths annually in India. RVV was introduced in 2016 in a phased manner, beginning with four states initially and later expanded to seven more states making it a total of 11 states by end of 2018, where RVV was available in the country. The vaccine has been further expanded to 17 more states. RVV is now available in 28 states/union territories (UTs), namely, Andhra Pradesh, Haryana, Himachal Pradesh, Jharkhand, Odisha, Assam, Tripura, Rajasthan, Tamil Nadu, Madhya Pradesh, Uttar Pradesh, Manipur, Daman and Diu, Gujarat, Bihar, Sikkim, Arunachal Pradesh, Chhattisgarh, Maharashtra, Dadra and Nagar Haveli, Goa, Chandigarh, Nagaland, Delhi, Mizoram, Punjab, Uttarakhand, and Andaman and Nicobar Islands. The vaccine is expected to be available in all 36 states/UTs by September 2019.

India also still lacks a robust system to track VPDs. Vaccination coverage varies considerably from state to state, with the lowest rates in India's large central states. Differences in uptake are geographical, regional, rural-urban, poor-rich, and gender-related. We now need to step up our efforts to strengthen all components of UIP (vaccination schedule, delivery and monitoring, and VPD/AEFI surveillance), overcome all barriers (geographical, politico-social and technical) and invest heavily in R&D to achieve immunization's full potential and a healthier nation.⁸