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Thursday, October 17, 2019

Towards an administrative framework for building public trust in vaccination

by Siddhartha Srivastava.

In January 2019, the Delhi government published a notification mandating the administration of the Measles-Rubella (MR) vaccine to all children between 9 months to 15 years of age. The vaccine was meant to be delivered as a booster shot irrespective of the previous vaccination status of the child. The notification did not provide any information with respect to the manner in which the MR campaign was to be carried out. Instead, it stated that since the "Measles-Rubella (MR) campaign is a National Policy like the Pulse Polio Programme...no consent is required from the beneficiaries/their parents". This led to widespread panic among parents who eventually filed a petition before the Delhi High Court challenging the notification. The notification was challenged on the grounds that the express consent of the parents was not a requirement for administering the booster shot.

In response to the challenge, the Delhi High Court ordered a stay on the administration of the MR vaccine in the city and directed the Delhi government to ensure that express parental consent was obtained before the measles vaccine could be administered to children. The court also directed the Delhi government to publish advertisements with respect to the procedure of administration of the vaccine as well as information with respect to the side-effects of the booster dose such that parents can provide their informed consent for vaccination.

Background

The judgment comes at a time when there has been widespread opposition to the introduction of the MR campaign in several states across India. Punjab, Karnataka, Kerala, Tamil Nadu and New Delhi have all witnessed vaccine hesitancy in different forms in relation to the administration of the MR vaccine. While the judgment poses significant questions about the role of individual consent in the delivery of public health goods by the state, this article is limited in scope to proposing a streamlined administrative framework for vaccination in India, one that contains internal controls to discourage vaccine hesitancy. Using the MR campaigns conducted in three different Indian states as case studies, we offer insights into the establishment of a proposed administrative framework such that the gains from immunisation are not offset by the growing threat of vaccine hesitancy in the country.

Methodology

We examine MR campaigns conducted by the state governments of Delhi, Tamil Nadu and Kerala by using primary and secondary legal sources:

  1. Notifications/circulars issued by central and state governments with respect to the implementation of the MR campaign (see, here and here).
  2. Judgments arising out of litigation against vaccination campaigns and vaccine liability (see, here and here).
  3. Legal papers and journal articles on mechanisms to deal with issues of vaccine hesitancy.
  4. News articles reporting cases of vaccine hesitancy in the chosen states.

We reviewed these materials with a view to understand the current framework of vaccine administration in these states with a specific focus on the processes present in these frameworks (or lack thereof) to deal with vaccine hesitancy. We compare India's approach to vaccine administration to that of the United Kingdom, Canada, Australia and the United States. Accordingly, we attempt to derive best practices that can contribute to a model administrative framework for vaccine delivery specific to India with inherent checks and balances to address vaccine hesitancy. (see, here, here, here and here).

Analysis

A study of the MR campaigns undertaken in Delhi, Tamil Nadu and Kerala suggest that vaccine opposition in these states can be broadly attributed to the following causes:

  1. Shared beliefs about safety, efficacy, potency and manner of delivery: Parents in Delhi are apprehensive about the effects of a booster dose of the MR vaccine given that their children have already been vaccinated for measles.
  2. Difficulty in accessing and understanding credible scientific information on vaccination: With the internet having become a repository of health-related information and in the absence of a framework for regulation/monitoring of such content, South Indian states such as Tamil Nadu and Kerala have witnessed the spread of erroneous, non-scientific information regarding vaccines over the internet and other media. Widespread misinformation and rumour-mongering on the internet, especially social media, has been a common characteristic of the MR campaigns across the country.
  3. Difficulty in accessing and understanding the legal/regulatory framework governing vaccination: Parents in Delhi and Kerala have raised concerns about scattered and often incomplete rules framed by state governments to undertake the actual administration of the MR vaccine.
  4. Reliance on religious, cultural and personal beliefs rather than proven facts and evidence: Opposition to the introduction of the MR campaign in Delhi, Kerala and Tamil Nadu suggests that vaccine hesitancy is not uniform across communities in each state but tends to occur in specific clusters (such as specific religious communities or groups that believe in non-traditional medicine). The identification of vaccine hesitant subgroups is imperative to understand the causes of their hesitancy and develop targeted interventions to increase vaccine uptake.

Towards a Trust Based Framework

Keeping in mind the causes of vaccine hesitancy in India, it may be helpful to design an administrative framework to streamline vaccine delivery with built-in checks for tackling vaccine hesitancy. The presence of an administrative machinery may be useful in addressing the public trust deficit in vaccination, in terms of:

Building greater credibility around vaccines: The administrative framework must be approved by a body of public health experts including vaccination professionals in order to allay fears relating to potency, efficacy and safety of the dose being administered. The United States Advisory Committee on Immunisation Practices (ACIP) and the United Kingdom Joint Committee on Vaccination and Immunisation (JCVI) are examples of such expert committees that provide recommendations for vaccine administration and monitoring. The ACIP is subject to the Federal Open Meetings Act of the United States which requires all meetings of the ACIP to be carried out in public as a trust building measure. In India, the National Technical Advisory Group on immunization (NTAGI) advises the central government on technical issues related to vaccination. The meetings of the NTAGI are close-door and infrequent. NTAGI sub-groups and expert advisory groups are constituted on an ad-hoc basis to address specific issues, and industry representatives are invited to present data but do not participate in discussions. Therefore, there is an urgent need for the functioning of the NTAGI to be made more transparent. Moreover, in addition to advising on the technical aspects of vaccination, there is a critical need for the NTAGI to consider issues such as vaccine access and coverage, safety, and hesitancy more frequently. Measures recommended by the NTAGI to strenghten monitoring and supervision, reduce immunisation drop-out rates and improve VPD and AEFI surveillance should be more heavily advertised with a view to address the fears of the public.

Formalising an awareness/communication strategy for vaccines: The administrative framework should contain strict rules for engaging with the public. This includes provisions for ensuring frequent awareness campaigns, dialogue with members of different communities, public campaigns by doctors, vaccinators and other public health experts, media outreach through public figures etc. Rules for engagement with the public during the introduction of new vaccines, changes in immunisation schedules and experimental vaccine trials can prove useful in reducing public fear at the outset. A compelling example of the effect of a well-formulated communication strategy can be found from within India itself in it's pulse polio campaign of the late 1990s. Targeted communication played an important role in raising awareness and building trust in the polio campaign with popular media figures and sports personalities advocating the benefits of vaccination over various media such as film, television, radio and print.

Formalising the procedure for vaccine delivery: Organised and accessible rules of procedure with respect to time, place and manner of vaccination can strengthen public confidence in vaccines. Specific information with respect to vaccine description, quality, indications, contraindications, side effects, dosage, age group, manner and place of delivery, catch-up immunisations etc. can provide a measure of certainty to parents and make them more comfortable in engaging with vaccination campaigns of the government. For example, each state in the US has it's own set of immunisation laws and regulations. These laws are procedural in nature and set out the administrative mechanisms through which schools, universities, pharmacists, and health-care facilities etc. are required to administer the various vaccines prescribed by the ACIP. In India, we find that the exact mechanism/process of vaccine delivery changes constantly based on where the vaccine campaign is being carried out and the nature of the campaign itself. For example, certain states prescribe that immunisation take place only in schools while others allow for vaccination at schools, public health centres, home-visits etc. As such, there is a need for consistency in the procedures followed to administer vaccines, one which can be addressed by having a set of codified procedural rules for vaccination in each state.

Monitoring, evaluation and reporting: The administrative framework may specify reporting requirements. Requirements with respect to monitoring and reporting the incidence of vaccine preventable diseases, coverage rates and adverse effects following vaccination (AEFIs) can assist in the formulation of stronger mitigation strategies for vaccine preventable diseases. Australia has adopted a national surveillance system that reports instances of adverse events following immunisation from state and territory registries as well as data sent directly from consumers, health professionals and vaccine manufacturers. These reports are regularly reviewed by the regulator and referred as required to expert committees, such as the Advisory Committee on Vaccines, to ensure ongoing safety assessments. In India, an AEFI surveillance framework has been in place since 1998. The national AEFI guidelines provide a set of standards for undertaking the investigation and assessment of cases reported as AEFIs. All states and districts are required to constitute AEFI committees, which assist in streamlining AEFI surveillance at the local level. However, the number of serious AEFIs reported in India are still far lesser than expected numbers. A large number of AEFI committees established at the state and district level are not functional, as a consequence of which there is insufficient real-time AEFI data being generated and stored accross the country. Recent reports suggesting the presence of the polio type 2 strain in oral samples of polio vaccines expose the inadequacies in our current monitoring and evaluation systems while further making the case for a standardised administrative framework for vaccine delivery.

Establishing a mechanism for accountability: The administrative machinery should include a mechanism for empowering communities to question vaccination practices, introduction of new vaccines, reasons for the occurrence of AEFIs etc. This will be a useful departure from the current practice of placing blame on state governments, without having any recourse to an institutional/administrative mechanism for grievance redressal. In order to ensure accountability, more than 15 countries around the world have instituted compensation mechanisms for vaccine related incidents. In these countries, compensation is dispersed either through courts or a compensation scheme pay-out for individuals that have suffered injury or death following vaccination. Even in India, consumer protection forums have considered and indeed ordered compensation for vaccine-related injuries and deaths in the past. However, an institutional apparatus similar to the US (which lists the nature of vaccine-related injuries that can be compensated under the National Childhood Vaccine Injury Act and requires the claimant to show a demonstrable link between the vaccine and the injury) can help provide a platform for vaccine accountability while at the same time evading frivolous claims.

Providing positive incentives for vaccination: Various countries seek to achieve their vaccination mandates by conditioning benefits, such as access to public/private services, on compliance with state vaccination requirements. Mandatory vaccination for enrollment in public schools falls within this category. However, rather than benefits, it is viable to condition incentives on compliance. For example, The Patient Protection and Affordable Care Act (ACA) of the United States requires insurers to fully cover the cost of recommended vaccines, relieving consumers of the entire expense of vaccination. The proposed administrative framework may contain additional incentives in order to discourage vaccine hesitancy in different subgroups in India.

Given the recent declaration of the WHO that vaccine hesitancy is one of the top 10 global health threats in 2019, and amidst the resurgence of measles outbreaks in different parts of the world, it is imperative that we start developing, implementing and evaluating measures to better address the complex problem of vaccine hesitancy. A well formulated and transparent administrative machinery can be a useful starting point for addressing this problem and fully realising the gains from immunisation in India. Moreover, the presence of such a framework can also act as a foundation for engaging in separate debates around the viability of individual consent vis-a-vis mandatory compliance with respect to legal/ administrative interventions designed to deliver public health goods.

References

Gopichandran, Vijayprasad, Public trust in vaccination: an analytical framework, Indian Journal of Medical Ethics, 2017.

Kumar et al., Vaccine hesitancy: understanding better to address better, Israel Journal of Health Policy Research, 2016.

Nadimpally et al., An idea whose time has come: compensation for vaccine-related injuries and death in India, Indian Journal of Medical Ethics, 2017.

Jarret et al., Strategies for addressing vaccine hesitancy - a systematic review, Vaccine, 2015.

 

The author is a researcher at the National Institute of Public Finance and Policy. The author thanks Prof. Ajay Shah, Dr. Renuka Sane and Mr. Shubho Roy for their useful comments and guidance.

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