All stakeholders — government, academia, industry, public health systems, health providers and the community — need to be engaged to formulate rational and relevant vaccine policies.
Vaccines are considered the greatest of public health strategies to prevent disease. The marked reduction of many infectious diseases from regions with good public health programmes argued the case. The eradication of smallpox was a triumph in this area. Nevertheless, there are many ongoing debates on vaccines and their use in India.
Public concern about vaccines dates back to the introduction of vaccine legislation in the mid-1800s. There are recent public apprehensions about vaccines; those who voice them are not against vaccination per se. Such concerns arise because vaccines differ from other medical interventions, as it involves healthy individuals being immunised to achieve a protective public health benefit. The public, empowered by the internet and sophisticated social media, want answers to their concerns. Their questions include safety, schedules, affordability, relevance, benefits, risks and funding. Several factors drive public anxiety: poor immunisation coverage of established inexpensive vaccines, push for newer expensive products, perceptions about the vaccine industry, conflicts of interest among decision makers, perceived pressures on institutions responsible for public policy, scepticism about scientific truths and perceived risks.
There have been several recent public-relations disasters for academia and the vaccine industry. A scientific publication, later discredited and retracted, documenting a link between the measles, mumps and rubella vaccine and autism tapped into a reservoir of public paranoia. The failure of the predicted swine flu pandemic to materialise combined with profits for vaccine and pharmaceutical industries, increased public mistrust of health authorities.
Many factors drive public perceptions. While scientific evidence and economic analysis have a major impact, a complex mix of psychological, socio-cultural and political factors also drives public discernment.
The scene in India
Vaccination programmes and policies in India have to contend with many complex issues.
Adverse effects: Vaccines are very safe and many studies have documented that their adverse effects are very rare or very minor. However, poor monitoring systems in our country do not allow for systematic surveillance. Adverse events after immunisation are strong factors that prompt rumours. Consequent public concern undermines the voluntary nature of vaccination programmes. Although the government does have some information, the lack of systematic data collection does not allow for robust defence of the programme.
Deaths: Sudden deaths after immunisation are not unheard of and occur very, very rarely. However, the system of investigation into such tragedies is non-uniform and many enquiries tend to absolve the vaccine and procedures. The denial of problems and post-hoc compensation for such tragedies put the whole programme at risk. Drastic changes in procedures in response to post-vaccination deaths, as in Tamil Nadu, compound the problems. The insistence that all children be brought to primary health centres for immunisation resulted in markedly reduced coverage. Rumour has it that an error by an individual resulted in far-reaching changes in policy and practice.
Vaccine supply: The sudden forced stoppage of essential vaccine production by government manufacturing facilities resulted in massive disruption to immunisation schedules and programmes. Squabbling among politicians, civil servants and experts did not instil public confidence. The subsequent judicial intervention, months later, restored manufacturing at these facilities but the disaster resulted in public distrust.
Private players: Liberalisation of the Indian economy has increased the number of private players in the vaccine industry. Many private players made a killing when government manufacturing was stopped. The government's neo-liberal agenda and the captive market for vaccines present an obvious business opportunity for exploitation. Consequently, the right-to-health-care argument has found enthusiastic support from the vaccine industry. The recent attempts to argue for expensive vaccines with limited protection (e.g. pneumococcal vaccine) for uncommon disorders fuelled speculation about the role of big business in pushing commercial interests.
International involvement: Many international financial institutions are more than willing to fund vaccine programmes. However, their focus tends to be on the newer and more expensive vaccines and for pre-production and monopolistic pricing arrangements. The high prices, often out of reach of poorer nations, make such ventures suspect.
Failed pandemic: The failure of the swine flu pandemic to materialise, after the initial hype and scare, played into the hands of the vaccine and pharmaceutical industry, which bagged massive contracts. While the post-mortem of the decision making process exonerated international health agencies, procedural lapses like failure to publically declare conflicts of interests among decision makers, resulted in adverse publicity and increased scepticism of health authorities.
Unethical trials: Deaths of young tribal girls enrolled in the human papillomavirus (HPV) vaccine trial in Andhra Pradesh resulted in suspension of the programme. Issues related to conflicts of interests and unethical nature of informed consent and recruitment procedures highlighted a callous approach of industry, non-governmental organisations and health authorities.
International disagreements: International disagreements add to public concerns. These include the American recommendation for the removal of thiomersal (a chemical to prevent biological contamination) from childhood vaccines, the French decision to withdraw the hepatitis B vaccine from school programmes, and the temporary Japanese suspension of the Haemophilus influenza B vaccine. The unwarranted controversies related to the tetanus vaccine and sterilisation in Mexico and the polio vaccine and HIV in Nigeria did not help the cause.
New reality: Deception employed to wage war (in Iraq), massive corruption within governments and collusion between business, politicians and bureaucrats has resulted in public suspicion of authority. Dialogue among consumers, via the internet, has facilitated the questioning of advice from traditional establishments. Media attempts for balanced coverage also allow highlighting of extreme views. Social media have allowed for the building of large virtual coalitions, which create a “social amplification of risk.” Vaccines have been so successful that low statistical risk takes on a different meaning. The internet, a vast archive of misinformation, mandates even greater need for public health education.
Polarised positions: Public concerns have resulted in public interest litigation and the use of the Right to Information Act to elicit information. The polarised positions of those for and against the new vaccines are obvious.
The vaccine industry and health authorities dismiss social context, economic concerns, human rights and political struggles as inconsequential. Scientists cite complex technical arguments, often based on non-Indian data, in support of new vaccines. They imply that all those who raise any objections are part of the anti-vaccine lobby. On the other hand, those against such initiatives emphasise the lack of good Indian data, selective citation of evidence and cast aspersions about business interests. The experts and the community, by their particular locations, differ on experience, perceptions, attitudes, and challenges. The absence, in the public domain, of information, evidence and policies, and the lack of transparency in decision making make it difficult for a rational and robust defence of either stand.
Traditional hierarchies, accepted for centuries, are being challenged in this new context and age. Increased cynicism and suspicion of authority is here to stay. Consequently, health establishments cannot dictate; they need to negotiate with communities and convince them of the need, rationale, efficacy and cost benefit of newer vaccine policies.
India can no longer ignore the elephant in the room, the limited data and the poor systems of information gathering, which do not allow for monitoring, generating evidence and rational policies. There is an urgent need to establish sentinel centres in order to determine the prevalence of the diseases and conduct large-scale trials to assess impact. Even though the vaccines may be efficacious, a detailed cost-benefit analysis from a public health perspective is mandatory for policy-making.
The current wave of public scepticism seen in many parts of the world has been described as a “crisis of confidence.” It mandates the restoration of public trust, essential for sustained vaccine coverage. Vaccine interventions and policies in the current socio-economic and political climate require much more than research evidence for implementation. Engagement with stakeholders and local politics, transparency in decision making, discussing uncertainties about risks and enhancing local ownership are crucial. Until then, arguments, based on polarised positions will continue with each side accusing the other of either obstructing progress or of making sound business investments at the cost of the nation's public health. There is a need for rigorous research to establish need, effectiveness and cost-benefit and for greater efforts at understanding factors that determine public trust. National policies need to be relevant, valid, accountable and participatory. Communication, dialogue and engagement with all stakeholders are crucial to building public trust, mandatory for successful vaccine programmes, and call for a revolution in policy-making.
(Professor K.S. Jacob is on the faculty of the Christian Medical College, Vellore. The views expressed in this article are personal.)