National Immunization Program: Historical and Contemporary Perspectives

Transcription

1 National Immunization Program: Historical and Contemporary Perspectives Manish Chaturvedi, R. Roy and S. Mukherjee Department of Community Medicine, School of Medical Sciences & Research, Sharda University, Greater Noida, India ABSTRACT Immunization is one of the most cost effective public health interventions and largely responsible for reduction of under-5 mortality rate. Annually, the country has approximately 29 million pregnant women and a birth cohort of approximately 26 million infants. The country is home to onethird of the world s unimmunized children. There are a number of reasons why India lags behind its own goals for immunization coverage. They include huge population with relatively high growth rate, geographical diversity and some hard to reach populations, lack of awareness regarding vaccination, inadequate delivery of health services, inadequate supervision and monitoring, lack of micro-planning and general lack of inter-sectoral coordination, and weak vaccine preventable diseases (VPD) surveillance system. In this article, the authors discuss the history of National Immunization Program, improvements with time, guidelines for Medical Officers for immunization, newer approaches for improvement of immunization coverage, introduction of new vaccines and the vaccines in queue. Successful acute flaccid paralysis (AFP) surveillance network should serve as platform for an efficient integrated disease surveillance system. Keywords : Immunization; Vaccine preventable diseases; Strategies; Performance Introduction The Universal Immunization Programme (UIP) in India is one of the largest Programmes in the world, in terms of quantities of vaccine used, number of beneficiaries, number of immunization sessions organized and the 25

2 National Immunization Program: Historical and Contemporary Perspectives geographical spread and diversity of areas covered. 1 Annually, the country has approximately 29 million pregnant women and a birth cohort of approximately 26 million infants. 2 Table 1 elaborate the district level household surveys findings. TABLE 1. District Level Household Surveys Findings One hundred seventy six (72%) districts surveyed showed a decrease in full immunization rates over the five years; average decrease 15.4% (varied from 0.1% to 64.2%) Sixty six (27%) districts surveyed showed an increase in full immunization rates over the five years; average increase 9.4% (varied from 0.1% to 41.1%) Two districts showed no change in full immunization rates Initiation of National Program for Immunization The success of smallpox eradication in the mid-1970s drew attention to the immunization programme in India. The Expanded Program for Immunization (EPI) in India was launched in The ambit of EPI was increased with the inclusion of measles vaccine in Considering the limitations of this shortsighted program like urban restriction, no cold chain maintenance and lack of vaccine supply, the program was launched again with wider focus and reduced shortcomings as Universal Immunization Program (UIP). The aim of UIP was to cover all districts in the country by 1990, in a phased manner and target all infants with the primary immunization and all pregnant women with tetanus toxoid immunization. In the same year, measles vaccine was added at 9 mo of age, but typhoid vaccine was dropped from the program. 3 Pulse Polio Program: A Success Story India launched the pulse polio immunization program in 1995 as a result of WHO Global Polio Eradication Initiative. Under this program, all children under five years are given two doses of OPV at 2 instances every year till the eradication of Polio. The campaign proved to be successful, and the incidence of polio in India has decreased dramatically to zero since Routine Immunization In India through routine immunization (RI) vaccines are given for six vaccine preventable diseases viz. tuberculosis, polio, diphtheria, pertussis, tetanus and measles. Table 2 shares the reasons of low immunization coverage. A specific Immunization Strengthening Project (ISP) was designed to run from , to strengthen routine immunization, 26

3 Source: Immunization Handbook for Medical Officers Fig. 1. History of Immunization Program improve effort for polio eradication and to give recommendations for strategic framework development. 5 After putting up a good show in its first decade ( ) with coverage of RI reaching 70-85%, there has been deterioration in the performance of UIP. The coverage of different vaccines has fallen by 15 to 20%. Loevinsohn et al. reviewed several studies for low coverage of routine immunization and found no association globally between polio eradication efforts and a decrease in funding for routine immunization or a decrease in routine immunization coverage but raised concerns about TABLE 2. Reasons for Low Immunization Coverage 1. Failure to provide immunization 2. Drop-outs 3. Unreached population 4. Resistant population 5. Missed opportunities 27

4 National Immunization Program: Historical and Contemporary Perspectives shifting the time of primary health workers from duties such as routine immunization to support polio eradication campaigns. 6 Addition of Newer Vaccines in the UIP For almost 2 decades, no new vaccine was introduced in UIP due to problems in poor coverage of routine immunization and no definite cost benefit analysis done in the country. However, other important vaccines of public health importance were added in a phased manner with Hepatitis B and now Haemophilus influenzae type b (Hib) as pentavalent vaccine. Since 2006 onwards, Hepatitis B, second dose of measles, Japanese encephalitis (JE) vaccine and Hib vaccine have been introduced. Hepatitis B vaccine was initially introduced in 10 states and then extended to whole country. The Japanese encephalitis (JE) vaccine has been introduced in 111 districts in 15 states having a high disease burden of JE. In December 2011, pentavalent vaccine [containing vaccine against diphtheria, pertusis, tetanus (DPT), Hepatitis B and Haemophilus influenzae type B (Hib)] was introduced in two states with high coverage of routine immunization (RI): Tamil Nadu and Kerala. Recently, the Government has decided to introduce it in 6 more states: Gujarat, Karnataka, Haryana, Goa, J&K and Pondicherry. 7 New Vaccines in Queue for Addition in UIP Technological advances have today provided an opportunity to further reduce childhood mortality due to other infectious diseases which can be averted with immunization. However, their introduction under the UIP have been delayed due to lack of conclusive evidence of their relevance to India, largely due to a lack of systematic, quality surveillance including laboratory confirmation throughout the country. These new vaccines are for pneumococcal, rotavirus, typhoid, rubella, meningococcal and (H1N1) influenza. The varicella, influenza, human papilloma virus (HPV), cholera, typhoid conjugate, mumps measles rubella as combination vaccine (MMR), inactivated polio and rota virus vaccines are licensed in the country and available for use in the private sector but are not currently part of the Universal Immunization Programme. Newer Approaches for Surveillance of Vaccine Preventable Diseases Recently, 11 centers across the country have been identified for laboratory supported surveillance for vaccine preventable diseases with special reference to potential vaccines in collaboration with the Indian Council of Medical Research (ICMR). In another recent initiative, name and telephone 28

5 TABLE 3. Specific Details of Vaccines of Routine Immunization Program 29

6 National Immunization Program: Historical and Contemporary Perspectives TABLE 3. contd... Source: Immunization Handbook for Health Workers, MOHFW 9 30

7 TABLE 4. Cold Chain Equipments 10 TABLE 5. Temperature Monitoring Gadgets 9 based tracking of pregnant mothers and children through a web enabled system has been introduced. The initiative intends to make sure that all pregnant mothers and children receive full continuum of care including complete vaccination. India has also joined the global post-marketing surveillance network for reporting adverse event following immunization (AEFI) associated with new vaccines and Maharashtra is the participating state. 7 Cold Chain: Tiers, Equipments and Gadgets All vaccines require a storage temperature in the range of +2 to +8 degree celsius, except for oral polio vaccine which can be stored in frozen state (- 25 to -15 degree celsius) at all stores except primary health center (PHC)/ community health center (CHC) / Health post where it should be stored at +2 to +8 degree celsius; cold chain being the most important component to ensure that quality vaccine is reached to each and every child immunized. This is also important in light of new costly vaccines introduction and also 31

8 National Immunization Program: Historical and Contemporary Perspectives Fig. 2. How to utilize domestic refrigerators at a clinic for storagre of vaccines of routine immunization Source: Handbook on Immunization for Medical Officers, NIHFW, MOHFW thrust on reduction and elimination of certain diseases like measles, tetanus etc. Successful Universal Immunization Program (UIP) requires a robust cold chain system to supply potent vaccines to the target children. The cold chain equipments and temperature monitoring gadgets are elaborated in Tables 4 and 5. India has five tier cold chain store systems to cater 30 million children vaccinations viz. Government Medical Supply Depots (GMSD), State vaccine store, Regional/Divisional vaccine stores, District store and PHC/CHC stores. 4 The current emphasis of Government of India (GOI) is to replace present cold chain equipments with chloro-flouro carbons (CFC) free equipments. The GOI is going to open National Cold Chain and Vaccine Management Resource Centre (NCCVMRC) in the National Institute of Health and Family Welfare. The center will provide trainings for cold chain maintenance; operationalize management information system (NCCMIS), remote maintenance of temperature with the help of data loggers, will coordinate the trainings at National Cold Chain Training Centre (NCCTC) located at State Health Transport Organization (SHTO), Pune. 10 Figure 2 demonstrates how different vaccines and diluents are to be kept in various compartments of the refrigerator. It is to be noted that no other material including food or drinking water is to be kept in the fridge 32

9 Fig. 3. Grading of vaccine vial monitor where vaccines are stored. It is mandatory to note the temperature of the fridge twice daily with a dial thermometer and remedial action to be taken if the temperature inside the refrigerator becomes higher than the desired temperature. The WHO has suggested through their policy document that Multidose vials from which at least one dose has been removed may be at risk of contamination of the vial septum. These vials should never, therefore, be allowed to be submerged in water (from melted ice for example) and the septum should remain clean and dry. NOTE: Well-sealed icepacks should be used in vaccine carriers and water should not be allowed to accumulate where the vials are stored. The physical appearance of the vaccine may remain unchanged even after it is damaged. The loss of potency due to either exposure to heat or cold is permanent and cannot be regained. To know about the potency loss due to heat exposure, a vaccine vial monitor (VVM) was introduced, to ascertain the potency of the same. 33

10 National Immunization Program: Historical and Contemporary Perspectives A VVM is a label containing a heat-sensitive material which is placed on a vaccine vial to register cumulative heat exposure over time. The combined effects of time and temperature cause the inner square of the VVM to darken gradually and irreversibly. Before opening a vial, check the status of the VVM. Promotion of Safe Injection Practice Unsafe injection practices pose serious health risks to recipients, health workers, and the general public. A recent INCLEN study demonstrated that 73.9% of injections given in the immunization programme were deemed to be unsafe. WHO estimates that in the South-East Asia region unsafe injections contribute to 31% of new cases of HIV, 59% of hepatitis B and 92% of hepatitis C. In India out of 25 million infants born every year, over 1 million run the lifetime risk of developing chronic hepatitis B virus infection. The community members and children are at risk of contracting deadly diseases, such as hepatitis B, hepatitis C and HIV as well as other types of infections. The provision of auto disable syringes by the Government of India and the implementation of Central Pollution Control Board (CPCB) outlined waste management procedures are attempts to improve injection safety in the immunization program. Guidelines were given for the safe disposal of immunization waste like store plastic part of syringes and unbroken empty vials in red bag and then treat them with 1% bleaching powder for 30 min. 5 Adverse Event Following Immunization An adverse event following immunization (AEFI) is defined as a medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization. AEFIs, particularly when they are not properly managed, represent a genuine threat to the immunization program and, in some cases, to the health of the beneficiaries. These are categorized into five types: vaccine reaction, program error, coincidental, injection reaction and unknown. As most adverse events are caused by program errors, one can minimize the chances of occurrence of an adverse event following immunization by adhering to the following procedures: 1. Use a separate site for each vaccine. 2. Use auto-disable syringes for all immunization injections. 3. Use new disposable syringe for each reconstitution. Never reuse it. 4. Always check the label for the name of vaccine/diluent, expiry date 34

11 and VVM before use. 5. Shake the T series and Hep-B vaccine vials before drawing the dose. 6. Reconstitute vaccines only with diluents supplied by the manufacturer for that vaccine 7. Record the time of reconstitution of vaccine on the vial label. 8. Use Measles and BCG vaccine within 4 h and JE within 2 h of reconstitution. If they could not be used with in stipulated time then discard the reconstituted vials, irrespective of number of doses remaining in the vials. Otherwise, there is risk of contamination with bacteria leading to toxic shock syndrome, a deadly and completely avoidable adverse event. 9. Never carry and use reconstituted vaccine from one session site to another. 10. Do not store other drugs or substances in the ice-lined refrigerator (ILR). These refrigerators are only meant for vaccines. 11. After injection, do not attempt to re-cap or bend the needle. 12. Ask the beneficiaries to wait for half an hour after vaccination to observe for any AEFI. 13. Leave the list of children vaccinated in a session with the Anganwari Worker (AWW) / Accredited Social Health Activist (ASHA) and request them to be alert and report AEFIs. 14. Share contact details of self and PHC. Intensification of Routine Immunization Government of India has declared as Year of Intensification of Routine Immunization. There were various interventions done to improve the RI, there are few of the strategies are described on the basis of each state: a. Strengthening Communication and Social Mobilization Six states with high population contribute to 80% of 8.1 million unimmunized children in the country; 52% of the total unimmunized children reside in Uttar Pradesh and Bihar alone. The Social Mobilization Network (SM Net) was created in 2003 to work in the northern state of Uttar Pradesh (UP) for strengthening routine immunization and to support polio eradication. Interpersonal communication and inter-sectoral communication channels were strengthened. b. Regular Program Review Regular meetings conducted at all levels viz. State, District, and block 35

12 National Immunization Program: Historical and Contemporary Perspectives level to review the progress and lacunae. c. Cold Chain Strengthening and Maintenance Effective Vaccine Management (EVM) exercise will be conducted in all priority states to assess and strengthen cold chain and vaccine management system. d. Teeka Express to Facilitate Alternative Vaccine Delivery (AVD) Teeka express, a four wheeler mobile service delivery mechanism is to provide services to underserved populations, tribal, hard to reach areas, urban and peri-urban areas and migrant population. This will also serve to brand immunization services and improve visibility of immunization programme. e. Strengthening RI Monitoring and Supervision Strengthening data quality and use of data for action: Currently, three information systems for RI exists [Health management information system (HMIS) for reporting, (RIMS) for local data analysis and use, and Mother and child tracking system (MCTS) for tracking beneficiaries]. There is a need for convergence of data generated from these systems for action. 7 f. Institutionalizing AEFI and VPD Surveillance National AEFI secretariat to monitor operations of AEFI surveillance system and provide support to states for investigation, causality assessment and feedback will be established at Ministry of Health and Family Welfare (MoHFW). All members will be trained in reporting, case investigation & management and causality assessment. Maharashtra state has set up Post Marketing surveillance system to be expanded to other states. g. Immunization Weeks to Cover All the Left Outs and Drop-Outs h. Operational Research Studies Operational research studies will be planned during in the areas of evaluation of Medical officer (MO) training in immunization; cold chain assessments; studies on vaccine freezing and injection safety studies. 2 Performance Measurement The performance of UIP is measured in terms of the vaccination coverage attained and dropout rates of children. Coverage rates, particularly of the first series of antigens as per the immunization schedule (i.e., BCG, DPT and HepB), are used as a proxy measure of access to immunization services. Alternatively, the trend of dropout rates is indicative of the 36

13 strength of the system including the quality of services and utilization. DTP3 (3rd dose of DTP vaccine) is used to indicate coverage of RI. Global Immunization Vision & Strategy (GIVS) target is to achieve 90% coverage at national level and > 80% coverage at district level. 7 Thus, the UIP system must be district-based in terms of inputs, outputs and monitoring/evaluation. In 2002, WHO, UNICEF, and other partners introduced the concept of Reaching Every District, which was the first step toward achieving more equitable coverage. This approach has started yielding good results wherever it was introduced. Today when we are going to get the certification for polio eradication, the experiences learned from Pulse Polio Program, the strategy can recast as Reaching Every Child. 11 There is a felt need for an institutional and country wide VPD surveillance system in India. CDC run integrated disease surveillance program (IDSP) based surveillance system, along with other systems (National Police Surveillance Project, Indian Council of Medical Research) need to be strengthened from district onwards to capture information on all VPDs to generate strong evidence base for policy decisions guiding introduction of new and underutilized vaccines. REFERENCES 1. Khera A, Gupta A, Gogia H, Rao S. India s National Immunization Program; 2. Strategic framework for Intensification of Routine Immunization (IRI) in India, Immunization division, MOHFW, GOI; National Vaccine Policy, MOHFW, New Delhi, 03: Multiyear strategic plan ; MOHFW, WHO & UNICEF: Loevinsohn B, Aylward B, Steinglass R, et al. Impact of targeted programs on health systems: A case study of the polio eradication initiative. Am J Public Health. 2002;92: Vashishtha VM, Kumar P. 50 years of immunization in India: Progress and future. Indian Pediatr. 2013:50: Handbook on immunization for medical officers, MOHFW,14: Immunization Handbook for Health Workers, MOHFW,GOI:2011: National Cold Chain Assessment India, MOHFW, WHO & UNICEF: Vandelaer J, Bilous J, Nshimirimana D. Reaching every district (RED) approach: A way to improve immunization performance. Bull WHO. 2008;86:a-b. 37