Adverse Event following Immunization
The Adverse Events Following Immunization (AEFI), vaccine safety and quality pillar, aims to support the MoHFW in establishing a functional AEFI surveillance system with a unified database of reports on vaccine safety. The overall goal of AEFI surveillance is to reduce morbidity and mortality due to AEFIs and minimize the negative impact of AEFIs on public health. The specific objectives are to:
- Promptly detect, report and respond to AEFIs;
- Identify unusually high rates of AEFI related to a specific vaccine lot / brand;
- Promptly address programmatic errors through implementation of corrective measures;
- Estimate serious AEFI rates in the population and compare these with local and global data; and
- Identify signals of unexpected adverse events and generate new hypotheses about these events that must be confirmed by planned studies and laboratory investigations.
The AEFI unit at ITSU also hosts the Secretariat for the National AEFI Committee. It provides techno-managerial support to MoHFW for improving surveillance and data support for analysis, follow up and feedback which is essential for policy and program development. The strategic focus of the unit is to:
- Provide techno–managerial support for effective functioning of the National AEFI Committee for design and review of policies and recommendations aimed at strengthening AEFI surveillance;
- Provide technical assistance to MoHFW and states to strengthen AEFI detection, reporting, investigations, monitoring, causality assessment and response to AEFIs including capacity-building activities and developing standard guidelines;
- Coordinate AEFI and vaccine safety surveillance activities with other vaccine pharmacovigilance stakeholders including CDSCO (Central Drugs Standards Control Organization), CBHI (Central Bureau of Health Intelligence), PvPI (Pharmacovigilance Programme of India), WHO-ICO NPSP(World Health Organization-India Country Office, National Polio Surveillance Project), UNICEF (United Nations International Children’s Emergency Fund), Indian Council of Medical Research (ICMR), and professional medical and national associations;
- Liaison with state, national and international agencies for expanding the vaccine safety database and conduct operational and implementation research for further improving AEFI surveillance; and
- Sustain confidence in immunization as an important public health intervention and develop evidence base for monitoring vaccine safety.
Evidence to Policy
The Evidence to Policy unit at ITSU focuses on strengthening the evidence base on the policies, practices and implementation of the Universal Immunization Programme. The unit aims to collate and analyze available data on disease burden, vaccine efficacy and safety and cost-effectiveness of vaccines to strengthen evidence-based decision making in immunization policy and program. In addition, the unit aims to collate and synthesize evidence on the changing epidemiology of Vaccine Preventable Diseases (VPDs) from various sources such as National Center for Disease Control (NCDC), Health Management Information System (HMIS) and other national sentinel surveillance sites, to measure the impact of the UIP and inform decision making for immunization policy. As the home of the secretariat to the National Technical Advisory Group on Immunization (NTAGI), the country’s apex advisory body on immunization, the work of the unit is a vital link between scientific evidence and immunization policy. Its main functions are listed below.
- Strengthen evidence base and develop data driven decision support tools to aid informed decision making on matters related to immunization policy and program.
- Support evidence generation to assess the case of new and underutilized antigens in UIP based on system readiness, avertable burden, program costs, and cost effectiveness. A new cross sectional survey called Integrated Child Health and Immunization Survey (INCHIS) has been designed to obtain nationally representative data on immunization coverage and child health. This survey will periodically collect data at a national level to measure progress related to immunization coverage, child health and its system determinants.
- Collate surveillance data on Vaccine Preventable Diseases in the country by engaging multiple stakeholders, such as the Integrated Disease Surveillance Programme (IDSP), NCDC, and WHO-NPSP to inform NTAGI decision making.
- Provide a platform for promoting dialogue and collaboration between national and international researchers, policy makers and other immunization action partners for strengthening evidence base on immunization policy and program.
Program Operation, Monitoring and Evaluation
The Program Operation, Monitoring and Evaluation (PO&ME) Unit aims to strengthen immunization operations, enhance the quality of data on immunization, especially the Mother and Child Tracking System (MCTS) and the Health Management Information System and develop immunization coverage improvement plans to support the Universal Immunization Programme. Its objectives are listed below.
- Developing Immunization Coverage Improvement Plans for four high priority states (Bihar, Madhya Pradesh, Rajasthan and Uttar Pradesh), with special focus on underserved areas.
- Establishing the centralized immunization data repository for monitoring program performance at the state, district, and sub-district levels and development of user-friendly and technology-supported solutions for data analysis and consolidation.
- Conducting Immunization Data Quality Assessment and developing state-specific Immunization Data Quality Improvement Plans in the high priority states.
- Strengthening the Mother and Child Tracking System that ensures name-based tracking of beneficiaries for improving access to health services for mothers and children.
- Supporting MoHFW and UNDP in developing a national monitoring and evaluation plan for UIP.
A two-tiered approach is being adopted for increasing visibility by rebranding Routine Immunization with a “Rights-based approach” repositioning it as “every child’s right”, and increasing awareness through social mobilization. The objective is to enhance awareness amongst the community regarding the RI schedule and adherence to timelines through a variety of media platforms/channels and collaborative ventures, increasing their knowledge and translating their intention to action.
Families and communities residing in rural areas
- Mobilize community for participation in advocacy and implementation and increase demand for services through frontline workers.
- Support states to ensure regular coordination/meetings between health care providers and village influencers for inactivated poliovirus vaccine (IPC).
- Promote involvement of the wider community and district networks – governmental, non-governmental civil society organizations and other active groups.
Hard to reach and underserved populations
- Collaborate and engage with the private sector to leverage their Corporate Social Responsibility (CSR) initiatives for immunization activities such as (1) adoption of villages and organizing health camps and (2) coordinating media visits to these villages for enhanced program visibility.
- Use mobile vans to make services available in these areas.
- Enhance mass media outreach in media dark areas of the states/district through government publicity channels.
Planning exercises are being undertaken with the states to develop state-specific Behavior Change Communication (BCC) action plans, based on evidence and tailored to address local needs and context (culture, etc.) to reach the target groups. This includes advocacy and social mobilization plans and capacity building plans. Government systems are being strengthened at the state level through capacity building of program managers to effectively plan, budget, implement, monitor and document communication interventions. At the same time, capacities of program managers are also being strengthened to effectively engage with the community and media for regular RI services and also during crisis situations.
The Strategic Communication unit is supporting states in detailing communication activities in their state program implementation plans (PIPs).
Coordination and Convergence
Support is being provided to states in engaging with institutions, community networks, youth clubs/ organizations and religious groups in a coordinated way to reach families and caregivers with planned messages and facilitate community dialogue on RI.
Importance of communication is being highlighted on several platforms with policy makers, including allocation of separate funds for RI communication.
Policy makers at the national level
- Apprise and regularly update policy makers about the situation on the ground after identifying demand side barriers to immunization service delivery at all levels.
- Emphasize immunization as an equity and rights based approach.
- Orient policy makers to be effective spokespersons.
- Negotiate for allocation of separate funds for RI communication.
Policy makers at the state level
- Advocate with states to institutionalize a reward and recognition system for well-performing health providers/ community mobilizers through public recognition of their work so that they feel pride in their work.
- Advocate with states to engage with local MLAs and MPs to utilize their funds to ensure that each and every child in their constituency is vaccinated.
- Mobilize state resources to organize camps in the constituencies of local MLAs and MPs and ensure their participation, helping create goodwill amongst the community.
The Strategic Communication unit would work with states to:
- Facilitate regular meetings to promote inter-sectoral synergies through convergence of RI with ICDS, Panchayati Raj Institutions for improved social mobilization;
- Strengthen delivery of interpersonal communication on RI using the social mobilization network for polio immunization (in SMNet states of UP and Bihar);
- Conduct orientation/ sensitization programs for Panchayat Raj Institutions (PRIs) on their roles and responsibilities in promoting RI; and
- Develop action plans for social mobilization activities, conducting community meetings, addressing refusals and operational bottlenecks at village/blocks and district levels.
A media engagement strategy has been developed through a hired media agency for informing, engaging and updating media personnel at each level in reporting RI related events.
Engage with the media, both print and electronic, at all levels (local, state, national and international), so as to:
- Enhance understanding of the media on the situational and strategic challenges facing the immunization program;
- Inform them about the sources of accurate scientific information and for accountable reporting and public empowerment;
- Increase sustained evidence-based and positive program coverage in the media on Routine Immunization and new vaccines; and
- Seek support from the media (health beat journalists from prominent national dailies - English, Hindi and vernacular) for scientific news reporting and human interest stories, op-ed articles from eminent technical and scientific experts, articles/stories on RI, dispelling myths/misconceptions around immunization, vaccine safety, and challenges /opportunities of new vaccines.
- Sustained, evidence-based and scientific reporting and coverage
- Create a strong positive public opinion on RI
- Placement of articles in leading newspapers written by eminent technical experts
- Capacity building of AEFI committee members to handle media
- Participation of technical experts on talk shows and other public platforms
Introduction of new vaccines
As India considers adding new antigens (e.g., rotavirus, pneumococcal, MMR, HPV, IPV/hexavalent, cholera, typhoid, and JE) the media needs sensitization so that positive and enabling environment could be created around the vaccine. For accomplishing this, the Strategic Communication unit will
- Garner support from the media through opinion pieces in leading newspapers,
- Orient media personnel for evidence-based and scientific reporting and coverage in the media, and
- Facilitate participation of technical experts on talk shows and other public platforms.
Engaging with Social Media
A social media agency would be hired to develop a strategy for a digital campaign for increasing immunization coverage, which will include planning, buying and tracking digital media. The agency will help raise awareness, pledge support for RI to help spread the message as well as take concrete actions. The RI campaign would be measured, monitored and evaluated on a regular basis by the agency both quantitatively and qualitatively.
Strategic Planning & System Design
For efficient planning and implementation of the immunization program, there is a need for greater coordination between MoHFW, state governments and other stakeholder working in the area of routine immunization. The Strategic Planning & System Design (SP&SD) unit of ITSU works with the Ministry of Health and development partners like GAVI-the Vaccine Alliance, WHO, UNICEF, other multilaterals donors, bilateral agencies and NGOs to address the design challenges in different aspects of the immunization program such as financing, infrastructure, service delivery, supplies and capacity building.
This cross functional unit assists MoHFW in setting goals through comprehensive multi-year planning, reviewing the availability and utilization of health infrastructure and its ability to absorb cross learning from different states and other stakeholders.
The unit also hosts the GAVI Secretariat as part of the grant for implementation of the GAVI-Health Systems Strengthening (HSS). The grant supports RI in 12 states to improve immunization coverage in India.
The main objectives of the SP&SD unit are listed below.
- Assist the Ministry of Health and Family Welfare in developing the national policy for vaccines and immunization, setting targets and preparing guidelines for effective program management.
- Undertake periodic review of the efficiency and effectiveness of the immunization program and guide the program to address constraints in system design and implementation mechanisms at national, state and district levels.
- Support MoHFW and coordinate with key stakeholders for roll-out of newer vaccines, approved by the Government of India, to be included in the RI program. These include IPV, MR, Rotavirus and adult JE vaccines.
- Financial planning for UIP.
- Support MoHFW in designing, piloting and nurturing innovative operational strategies.
- Collaborate with all stakeholders to advocate for increased commitment to immunization at all levels and develop new partnerships for synergies in effort.
Vaccine Logistic and Cold Chain Management
Vaccines are among the most cost-effective healthcare interventions available in the world today. As per the Coverage Evaluation Survey (CES 2009), 61 percent of children in India are fully immunized, leaving 39 percent either unimmunized or partially immunized. There are a variety of contributory factors to these missed children. Non-availability of some vaccines and syringes at session sites is one of the directly impacting elements. Availability is determined by the effectiveness of the vaccine logistics management system, from the national level up to the last cold chain point, in maintaining stock visibility across the supply chain, undertaking distribution planning, reducing wastage, and monitoring storage conditions. High wastage rates become important from a fiscal standpoint as newer and more expensive vaccines (such as Pentavalent, IPV and Rotavirus) are being explored for introduction into the national immunization program. Currently, vaccines are procured by the Government of India and supplied to states directly from the manufacturer. Under limited circumstances, buffer stocks from Government Medical Store Depots (GMSDs) are supplied to states. At the district level, a variety of vaccine management practices are being followed with inadequate distribution planning – resulting in both overstock scenarios and stock out conditions across storage points within a particular district. Also, reporting and recording formats (e.g. indent forms, stock registers and issue vouchers) are not standardized, resulting in an array of documents being used to document stock flows. The current system in the majority of states is paper based, without visibility of real-time stock levels.
The objectives of this unit are:
- Establishing a system for real-time vaccine logistics management across all cold chain points in the country;
- Establishing a reliable and dynamic temperature monitoring system to ensure vaccines are stored and transported under recommended temperature conditions;
- Development of national standard guidelines for vaccine logistics and cold chain; and
- Innovating and piloting new strategies to address vaccine delivery priorities through use of technology, strategic capacity building methodologies and global learning with the aim of Health System Strengthening.