Abstract
India’s inaugural Advanced Vaccinology Course, hosted by the Child Health Foundation and the International Clinical Epidemiology Network, attracted approximately 55 EPI managers and privately-practicing physicians from across the country. The comprehensive course provided training in epidemiology, disease surveillance, and vaccine safety and regulation. Core lectures highlighted vaccination trends, challenges, and innovations specific to India; ‘Breakout Sessions’ and the ‘State-of-the-Art Lecture Series’ complemented core course material. Overall, the course aimed to provide an advanced education in classic and topical areas of vaccinology to ensure that India has the tools and skills required to safely manage and grow its national immunization program.
Vaccination schedules, coverage & challenges
There are many factors to consider when charting a national immunization schedule. According to Thomas Cherian (WHO, Geneva, Switzerland), optimizing the schedule involves attention to immunological determinants, such as vaccine type (live, nonlive) and antigen type (polysaccharide or protein); epidemiological determinants, including vulnerable stages for the child; programmatic considerations, such as opportunities to sync with delivery of other interventions; and safety issues, such as timing the vaccination to avoid natural risks. An appropriate immunization schedule will balance all of these factors to ensure that vaccination occurs early enough to safely protect against disease exposure, but not so early that the child’s nascent immune system struggles to mount a response.
According to Ajay Khera (Ministry of Health and Family Welfare, India), India’s national immunization program (NIP) currently includes seven vaccinations: diphtheria, tetanus, pertussis, measles, polio, BCG and hepatitis B Citation[1]. Despite this schedule, roughly 11.5 million children in India are not fully immunized, and 75% of these children live in just seven states Citation[2]. Cherian cited four key challenges to increasing vaccination coverage in India: uninformed or fearful populations; program management difficulties, especially accessing hard-to-reach populations; low use of data for planning and corrective actions; and faulty vaccine supply chains that can result in stockouts.
Khera commented further on the lack of fully immunized children in India, classifying them into two groups: partially immunized (‘drop outs’) or never immunized (‘left outs’). A study of four Indian states (Bihar, Uttar Pradesh, Jharkhand and West Bengal) during the period June 2010–May 2011 demonstrated that ‘drop outs’ comprised the greatest number of fully unimmunized children, which, the study concludes, indicates awareness and information gaps and operational issues. According to Khera, in each of the four states surveyed, at least 40% of respondents cite information gaps and safety concerns as the reason for incomplete coverage Citation[3].
India has yet to introduce vaccines that protect against Haemophilus influenzae type b (Hib), pneumococcal disease or rotavirus into its NIP (though there are plans to introduce pentavalent Hib vaccines into two states in late 2011). Given the challenges surrounding traditional EPI vaccines, India will have to make serious investments into its immunization system to prepare for and adequately deliver new vaccinations. According to Cherian, weak immunization systems are a threat to the introduction of new vaccinations everywhere, as are concerns regarding financial sustainability and the availability of data.
Vaccination program logistics & management
Delivering vaccinations requires extreme coordination across several operational areas, which Alan Hinman (Emory University, USA) classifies as cold chain storage and transport; sterilization and injection equipment; training and supervision; and monitoring, evaluation and feedback.
Satish Gupta (UNICEF, India) described cold chain as “the lifeline of the vaccine”. While vaccines vary in terms of their sensitivity to changes in temperature, Gupta noted that most vaccines tend to lose potency once exposed to heat above 8°C. Some vaccines also lose potency when exposed to freezing temperatures (HepB, TT, DPT) and instead must be stored at or above 2°C. Gupta discussed some technologies that help to determine whether a vaccine has been exposed to excessive heat, including vaccine vial monitors. According to Ajit Tamhane (Lisaline Lifescience Technologies, India), the vaccine vial monitors change color if the vaccine vial’s cumulative heat exposure renders it unsuitable for human administration.
Edward Hoekstra (UNICEF, USA) discussed vaccine injection procedures and challenges. According to the WHO, he said, all countries should use only autodisable syringes for immunization injections Citation[4]; these syringes are modified for inactivation after a single use. Statistics from the Indian Clinical Epidemiology Network suggest, however, that 32% of the 3–6 billion injections administered annually in India involve used equipment, increasing the risk of spreading blood-borne viruses such as HIV Citation[5]. In Gujarat in 2009, 60 people died due to hepatitis in 5 days; investigators traced this outbreak to the re-use of needles by health workers. Hoekstra also discussed measures for safe disposal of immunization waste, including the role of hub cutters, disinfection solution and organized disposal sites.
Effective human resources (HR) management is also fundamental to the success of a NIP. Dileep Mavalankar (IIM Ahmedabad, India) discussed the outcomes of a study of the HR situation in India’s NIP. The study focused on distilling the existing HR organizational structure and identifying the HR needs required to improve the managerial capacities of India’s NIP. The study found that there were only three immunization managers at the national level, none of whom had specific training in immunization. The study connected the poor HR management to immunization challenges, citing poor staff development, breakdowns in cold chain and false reporting. The study recommended a new management structure that calls for 18 managers at the national level and five to six at the state level; these mangers should have immunization training, junior support staff and periodic program reviews.
Kolanda Swamy (Department of Public Health and Preventive Medicine, Government of Tamil Nadu, India) presented on the health system in the state of Tamil Nadu, with a particular focus on its unique management structure. Since 1923, the state has had a separate Directorate of Public Health and Preventive Medicine, which is staffed at all levels by public health professionals. The Directorate is responsible for crafting the state’s immunization strategy, which includes drafting annual microplans that detail, among other elements, ‘fixed day, fixed place, fixed time’ campaigns to maximize vaccination coverage. Tamil Nadu boasts the highest percentage of fully immunized children of any state in India, an accomplishment that the state attributes to its dedicated Public Health Directorate, emphasis on good management and supervision, and political will.
Maintaining & communicating vaccination safety
Chandrakant Lahariya (WHO, India) discussed the basics of adverse events following immunization (AEFI), which he defined as “a medical incident that takes place after an immunization, causes concern, and is believed to be caused by the immunization” Citation[6]. He classified AEFI into four major categories: vaccine reactions (e.g., anaphylaxis); program errors (e.g., human error): coincidental occurrences (e.g., health consequence by chance); injection reactions (e.g., fainting due to fear of injection); and other. According to Lahariya, program errors are the most common cause of AEFI in developing countries, and managing AEFI is therefore critical to maintaining the public’s confidence in the NIP. AEFI surveillance in India began in 1988, with new guidelines distributed in 2010.
Steve Black (CDC, USA) reviewed the merits of AEFI surveillance systems, including spontaneous reporting systems, such as the Vaccine Adverse Events Reporting System in the USA. He highlighted the strengths of the system, which include rapid signal detection, large catchment and the relative inexpense of the operation. However, he noted that the general limitations of a spontaneous reporting system – including reporting biases, lack of an unvaccinated comparison group, and inconsistent data quality and completeness – render the system inadequate to establish causality and more suited to generating hypotheses.
Shamila Sharma (UNICEF, India) noted the importance of carefully and effectively communicating the risks of vaccination, pointing out that fear of AEFIs is often exaggerated by the media. Sharma noted that major barriers to the acceptance of vaccination programs include awareness, education and literacy, as well as religious and cultural issues. She recommended discussing vaccines in the context of ‘lives saved’, not ‘lives lost’, and noting that the benefits of vaccination “far outweigh their risks, which are minimal”, to avoid unnecessary alarm. Sharma also suggested that vaccination officials avoid providing categorical assurances, leaving information gaps, or providing highly technical and complicated material.
State-of-the-Art lecture series
International vaccination experts delivered ‘State-of-the-Art Lectures’ on cutting-edge topics in the field of vaccination. Walter Orenstein (Emory University, USA) discussed strategies to end polio, which – as of 2010 – is endemic in four countries: India, Pakistan, Afghanistan and Nigeria. He described the “new polio end game” in three stages: phased removal of Sabin viruses, beginning with highest risk (type 2); elimination of vaccine-derived poliovirus type 2 in parallel with eradication of last wild polioviruses by switching from trivalent oral polio vaccine to bivalent oral polio vaccine for routine EPI and campaign administration; and early introduction of inactivated poliovirus vaccine (IPV), at least in high-risk areas for vaccine-derived poliovirus, to provide type 2 protection. He discussed an “affordable IPV strategy”, which includes reducing the number of doses of IPV (e.g., two doses at 14 weeks and 9 months), reducing the size of each dose (e.g., give one-fifth of the dose intradermally), and reducing the cost of production (e.g., partner with developing world manufacturers).
David E Bloom (Harvard School of Public Health, USA) discussed a new approach to economic evaluations of vaccination. He argued that existing evaluations tend to adopt a narrow perspective that neglects a host of vaccination-mediated productivity gains, thereby potentially resulting in an underestimate of the value of vaccination. Bloom presented a framework that moved beyond narrow (or traditional) vaccination-mediated benefits, such as health gains, healthcare cost savings and care-related productivity gains, and includes broader categories such as outcome-related productivity gains, behavior-related productivity gains and community externalities. He argued that accounting for the broad set of benefits is critical to properly assessing the full value of vaccination. Insofar as policy makers rely on the results of these evaluations, new approaches to economic evaluations of vaccination could prove decisive regarding vaccine introduction decisions.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
References
- Indian Academy of Pediatrics. IAP Guide Book on Immunization. The Indian Academy of Pediatrics, Mumbai, India (2011).
- World Health Organization-UNICEF. WHO/UNICEF Estimated Coverage: 1980–2010. WHO, Geneva, Switzerland (2011).
- Government of India. Routine Immunization Monitoring. Delhi Government of India, India (2011).
- World Health Organization. WHO-UNICEF-UNFPA Joint Statement on the Use of Auto-Disable Syringes in Immunization Services. WHO, Geneva, Swizerland (1999).
- Arora NK, Pandey RM, Kumar H, Chaturvedi S, Devi R, Adhish V. Assessment of injection practices in India: IndiaCLEN Program Evaluation Network (IPEN) study. Presented at: Public Health Without Borders. San Diego, CA, USA, 25–29 October 2008.
- World Health Organization. Surveillance of Adverse Events Following Immunization: Field Guide for Managers of Immunization Programs. WHO, Geneva, Switzerland (1997).