Need for caution
FOR almost a century now vaccination has been promoted by governments across the world as an indispensable public health measure to reduce incidence and associated mortality and morbidity from infectious diseases. In fact, use of vaccines and ability to control infectious diseases are looked upon as major public health success stories. Since the past couple of decades, cost-effectiveness has also been added to its list of merits.
India’s immunization programme is considered to be one of the largest in the world in terms of quantities of vaccines used, number of beneficiaries, the numbers of immunization sessions organized, the geographical spread and diversity of areas covered. An Expanded Programme on Immunization (EPI) was launched here in 1978 to initially control six diseases: diphtheria, pertussis, tetanus, poliomyelitis, typhoid and childhood tuberculosis. In 1985 the programme was universalized and renamed as Universal Immunization Programme (UIP); measles vaccine was included and typhoid vaccine was discontinued. The UIP was introduced in a phased manner from 1985 to cover all districts in the country by 1990, targeting all infants with the primary immunization schedule and all pregnant women with tetanus toxoid immunization. In 1992, the UIP became a part of the Child Survival and Safe Motherhood Programme (CSSM), and in 1997, it became an important component of the Reproductive and Child Health Programme (RCH). Intensified polio eradication activities were started in 1995-96 under the Polio Eradication Programme. Over the past decade there have been moves to introduce vaccines for more diseases into the UIP schedule, including combination vaccines such as pentavalent vaccines.
It is not widely known that there has been opposition to vaccination almost since its inception, such as to smallpox vaccination in England, United States and India in mid-late 1800s. In more recent times in developed countries there has been either questioning of or opposition on grounds of safety and efficacy of certain vaccines. Vaccination policies have also given rise to ethical problems, such as those of informed consent, mandatory vaccination, quarantine, etc. It is looked upon as an issue where measures required to promote public health conflict with basic human rights and liberties. It is also felt that as more and more vaccines are being developed, priority setting seems unavoidable. Hence, this requires ethical reflection, including evaluation of public risk of different diseases, reflection on value assumptions in cost-effectiveness analyses, and levels of effectiveness that must be attained with a particular vaccine.
In developing countries such as India, foremost among the concerns has been the vertical, campaign-based strategies adopted for immunization since the mid-1980s, to improve coverage and/or target a specific disease. The concern with such campaign strategies is to do with their undermining of provision of routine services – immunization and other medical and health services – through a comprehensive primary health care system. Concerns are gradually enlarging to a more critical, evidence-based evaluation of immunization on criteria such as impact on coverage, quality of services, reporting of adverse effects following immunization, effectiveness, costs, introduction of vaccines for more infectious diseases such as influenza-malaria-cervical cancer, and strategies for production of vaccines. Such concerns have led to calls for a national vaccine policy within the ambit of a national health policy, based on principles of public health and comprehensive primary health care, in order to enable rational and evidence-based decisions regarding immunization. Such a draft national vaccine policy has been prepared and recommended by concerned public health practitioners, researchers and activists.1
Through the following two sections this article attempts to lay out some not so widely discussed issues in immunization – such as the information base for introduction of vaccines and/or adoption of immunization and of alternative public health approaches to tackle infectious diseases.
The first outlines the problem of deployment of scientific data, by examining the polio eradication initiative (popularly known here as pulse polio programme) and some other vaccines for childhood diseases. In January 2012, it was announced that the polio eradication initiative had been successful and a year had gone by without any reported polio cases.
Since the inception of the Polio Eradication Initiative in India in 1996, a disproportionately large amount of human and material resources have been invested in immunization against this single disease – polio, as against that for routine immunization. At that time polio eradication was not a priority for developing countries, including India, and there were considerations other than its public health importance in adopting this strategy. It simply had to be implemented as part of the Global Polio Eradication Initiative. In fact the National Commission on Macroeconomics and Health records that even before the benefits of the national immunization programme could be realized, this polio eradication initiative was launched. The NPSP (National Polio Surveillance Project) and a network of 148 polio laboratories were set up solely for identification and surveillance of polio. Tens of thousands of workers were trained to investigate cases of polio and manage pulse polio immunization activities. Apart from such extreme verticalization of a health programme, there are other extremely serious problems with the polio eradication initiative.
Many of the scientific assumptions of the ‘eradication’ programme regarding the persistence of wild type polio-viruses in the environment and their ability to mutate, the ability of the attenuated vaccine viruses to revert, were all inadequate to begin with, and have since been shown to be incorrect by a host of findings. It is beyond the scope of this paper to discuss in detail the findings of all the surveillance and genetic studies. Polioviruses are considered to be among the most rapidly evolving viruses. And it is amply clear now that polioviruses derived from the oral polio vaccine can acquire highly modified genetic structure by mutation and by genetic exchanges with vaccine viruses or wild polioviruses (WPV) or even with other non-polio enteric viruses (NPEV). These virus strains derived from the vaccine virus can survive for long periods of time, by prolonged excretion, and/or by natural transmission, and may cause poliomyelitis in humans. They may make their way through narrow breaches and evolve into transmissible pathogens, even in adequately immunized populations. Hence, a vaccine programme might inadvertently initiate an out-break of poliomyelitis, similar to natural outbreak. Low coverage and poor hygiene are conducive to such an occurrence.
Based on such findings, the very idea of ‘eradication’ of polio by wiping out the poliovirus was questioned, and experts had argued for a shift to control of poliomyelitis. In fact, as early as 1997, virologists had expressed serious concerns and argued against ‘marketing polio vaccination to poor countries as an "eradication" campaign’; they pointed out that to succeed the eradication effort should take a balanced approach as part of a larger campaign to improve health and sanitation. WHO was warned of these problems several years ago but it dismissed these concerns.
What we thus see is that even though all the problems were known, yet WHO and the government promoted the programme as a grand humanitarian task, and vast amounts of resources, financial and human, were used up solely for this programme. When polio cases continued to be reported well after the deadline of 2005, one of the measures adopted was to increase the pulse polio doses. The ‘pulse polio’ dose has been repeatedly administered (till last year at least 10-12 times a year since 2007 in some states). There has been excessive dosing of children in India with oral polio vaccine (OPV), at times exceeding more than 25 doses in the first five years of age. This is unheard of in the history of polio eradication in the West.
The point remains that in spite of such inadequacies in the ‘science’, how is it that there are no cases of polio, as reported by the government? There have been repeated changes in the definition of polio cases since 1996 – out of the thousands of cases of acute flaccid paralysis (AFP) reported only those with wild poliovirus detected in their stools are classified as polio cases. This leaves out a large number of cases of paralysis that would qualify to be classified as polio by the older definition based on clinical signs. In addition, there is obfuscation of the numbers actually afflicted by polio by use of multiple terms such as confirmed wild polio virus (WPV) cases, compatible cases, discarded cases, vaccine derived polio virus cases, and so on.2
Examination of the data collected by the National Polio Surveillance Programme shows that there has been an alarming increase in the number of children afflicted by paralysis since the beginning of this ‘eradication’ programme. It has steadily increased from 8103 in 2000 to 60,851 in 2011; the non-polio AFP rate in this period climbing from 1.99 to 12.74 (all figures from www.npspindia.org). It is imperative that a public health programme looks beyond paralytic polio and shows concern about the rising paralysis rates, and undertakes a complete epidemiologic investigation to ascertain the reasons for such an increase.
However, in their obsession with ‘polio eradication’, WHO and the government have turned a blind eye to this increase in paralysis rate across the country, as well as to the incidence of paralytic polio in children who had received more than three doses of the oral polio vaccine. There is neither any environmental surveillance, nor even adequate surveillance and follow-up of all paralysis cases in India as claimed by the implementing bodies. So we do not know the reasons for such an increase, nor about the nature of (polio) viruses that are present in the environment that children here are being exposed to. Given the present knowledge regarding evolution and mutation of the polioviruses, there is the possibility of an iatrogenic basis for paralysis. The possibility of ‘overdose’ of the OPV and variants of WPV and not just WPV causing paralysis needs to be examined.
Apart from these serious unresolved issues regarding the science of polioviruses and polio vaccines, the other problems prevailed – namely the pernicious effect the programme has had on the already emasculated health services of many states. It is acknowledged in official circles and in review reports that there has been decrease in routine immunization and other services due to the concentration on the pulse polio programme. In addition, while the general impression sought to be created is that the eradication programme receives generous external funds, it is only partially true. National resources from governments, NGOs and private sector, at the national, state, district and local community levels to cover petrol, social mobilization, training and other costs have matched external contributions. For instance: up to 2009, the Indian government paid up to 46% of the total costs incurred on the polio eradication campaigns by a combination of bilateral grants, domestic budgetary allocations, and loans from World Bank. Not only has the original concept of pulse polio immunization as a supplementary immunization activity (fixed doses of oral polio drops to be given to children in target group twice a year, 4-8 weeks apart, in addition to routine doses) been lost sight of by WHO and the other implementing bodies, the supplementary immunization became the sole immunization in most parts of the country. The issues of malnutrition, sub-optimal sanitation, concomitant diarrhoeal infections and, along with these, routine immunization for the other childhood diseases, remain neglected in favour of a vaccine technology as the sole strategy for addressing a single infectious disease. We see that since the turn of the century vaccines for several other infectious childhood diseases, such as pneumococcal disease, are now being advocated by WHO and other experts, irrespective of their public health need, in spite of insufficient information regarding their effectiveness, and their potential to cause adverse effects.3
What we see thus is not merely irrational scientific practices, such as promoting measures irrespective of their need, desirability, and effectiveness. There is also an inadequate information base for their efficacy, effectiveness, and usefulness, and on safety. In other words, there is a tendency to apply imperfect, costly, halfway technologies even before they have been proven to be safe or effective, and underplay adverse effects.
This raises the question of what are the barriers to having rational evidence and need based vaccine strategies. This in turn takes us to issues of political economy of vaccine production. There are a large number of vested interests (politely referred to as stakeholders) in the form of governments, sections of scientists, vaccine manufacturers, UN institutions such as WHO and UNICEF, and the World Bank. These interests have seamlessly aligned with the paternalism of multilateral aid, development, and philanthropic agencies, in the name of using science and technology to address the poverty and health problems of developing countries.
There now exists a supra-national corporation of all these interests called Global Alliance for Vaccines and Immunization (GAVI), announced at the 2000 World Economic Forum in Davos. GAVI is touted as a major public-private partnership of all the ‘stakeholders’ in immunization. A close ally of GAVI is the IFFIm – International Finance Facility for Immunization, a new ‘international development institution’ designed to make funds available for GAVI projects. In October 2006 the IFFIm launched a supranational bond to raise funds from potential investors, with the World Bank as its treasury manager. This is being projected as a new way of funding international development, and addressing ‘the seemingly intractable problems of poor nations with a tried and true model from the world of business’ (www.iff-immunisation.org). The point to ponder over is whether a rational vaccine policy is possible in the present national and international socio-political order?
From a public health perspective, yet another question can be posed: Is immunization the only scientific way to mitigate the effects of infectious childhood diseases? Is immunization the only preventive measure? Can there be alternative approaches?
Conventional categories of causes of death suggest that about 70% of the deaths of children (aged 0-4 years) worldwide are due to diarrhoeal illnesses, acute respiratory infection, malaria, and immunizable (vaccine preventable) diseases. Such classifications do not identify malnutrition as a cause of child mortality, despite the long-standing recognition of the synergism between malnutrition and infectious diseases. Resistance to infection is determined by a great many interrelated factors, but one of the most significant variables is the nutritional status of the host. The interaction between nutrition and infection has been described as synergistic, with malnutrition reducing resistance to infection, and infection in turn, negatively affecting nutritional status.
Time trends in the prevalence of under-nutrition among preschool children show that under-nutrition is a major problem among preschool children in India. Surveys by the National Nutrition Monitoring Bureau (NNMB) (1990-1991 to 2000-2006) and National Family Health Survey (NFHS) (1993-1994 to 2005-2006) surveys revealed that though there was a declining trend, the problem of under-nutrition is still alarming in India. As per the NFHS-I data (1993-1994), prevalence of under-nutrition in India was 53.4. 1n 1998, it reduced to 47.0 and 46% in 2005; however, the rate of change was discouraging. The NFHS surveys show that the levels of child malnutrition in India are exceptionally high and little progress has been achieved since 2000.
The NFHS-3 presents data on three commonly used measures of child malnutrition; stunting (deficit in height-for-age), wasting (deficit in weight-for-height), and the proportion of underweight (weight-for-age) children. According to this, 46% of below three year children are underweight, 38% were stunted and 19% were wasted. NFHS reports also show that the prevalence of under-nutrition is more among the rural children. According to the National Institute of Nutrition data for 2002, the extent of moderate to severe under-nutrition tended to increase with decrease in average monthly per capita income (PCI), from about 31% in HHs with PCI of or above Rs 900, to 53% in HHs with PCI less than Rs 300.
An epidemiological method was developed in the mid-1990s to estimate the percentage of child deaths (aged 6-59 months), which could be attributed to the potentiating effects of malnutrition in infectious disease. Using UNICEF estimates of underweight prevalence, the results from 53 developing countries with nationally representative data on child weight-for-age indicated that 56% of child deaths were attributable to malnutrition’s potentiating effects, and 83% of these were attributable to mild-to-moderate as opposed to severe malnutrition. For India, 67% of the child deaths were attributable to potentiating effects of malnutrition and of these 74% could be attributed to mild-to-moderate malnutrition.4 Such findings suggest that even mild-to-moderate malnutrition is as serious a health problem as severe malnutrition.
Given the above relation between malnutrition, infection, mortality, and the high prevalence of malnutrition among children in India, the point to ponder is: what would be a rational, effective way to tackle childhood infectious diseases – immunization to specific diseases or addressing the larger problem of malnutrition? In fact the extent of malnutrition could be much larger than the above given estimates – a section of concerned expert opinion warns that we have become a republic of hunger; that chronic hunger and starvation are major public health problems in the country. India is reported to have the largest number of malnourished children in the world. In such a situation, how effective will immunizations be in preventing morbidity and mortality due to infectious diseases?
How should the problem of widespread malnutrition and hunger be addressed – through just another set of nutrition programmes, targeted approach of food distribution or through more redistributive measures, broad structural changes and social justice?
The fascinating history of public health, since its origins in the massive social upheaval accompanying the coming of industrial capitalism in the West, and the way governments addressed such public health problems, and continue to do, hold some answers and lessons.5 They indicate that while causality and etiology help provide a theory and framework to design preventive programmes and action, yet in their final resolution it is political philosophies that ultimately matter.
Decades of aid and technical assistance to the ‘developing’ countries such as India have failed to achieve what a small island country has done over the same decades without such aid, and despite a 45-year old US- imposed trade-economic embargo. Cuba’s record in the area of infectious diseases is particularly noteworthy – they are not a major cause of death here as in so many developing countries. A number of common infectious diseases have been eliminated altogether, often for the first time in any country – poliomyelitis in 1962, neonatal tetanus in 1972, diphtheria in 1980, measles in 1993, pertussis in 1994, rubella and mumps in 1995.
In 1962, ‘vaccination days’ were established to reach the entire population, against the advice of external health officials. This method proved to be effective in eliminating polio and became the basis of the global polio eradication initiative of WHO and company, although in a completely attenuated form. Malaria has been eradicated, and dengue fever successfully reduced by an immense campaign with popular participation. There was a reduction of tuberculosis infections from around 30 to 5 per 100,000 from the 1970s to 1991, when it increased to 15 per 1 lakh because of difficult living conditions. However, the trend has been reversed since then.
Cuba now has the second lowest infant mortality in the Americas – 5.8 per 1000 live births in 2004, comparable to that of Canada (5.4), and USA (7.1); whereas in terms of GNP per capita Cuba compares with countries like Bolivia and Brazil (less than 10,000). The prevalence of low birth weight in 2004 was 5.4%. In 2005 the maternal mortality rate was 29 per 100,000 LBS. Yet, in national and international public health discourse there is little discussion and objective evaluation of the Cuban achievements. There is plentiful evidence to show that fifty years ago Cuba moved in the direction of health for all: by addressing then currently fashionable ‘social determinants of health’, by giving political priority to health, and through a comprehensive effective public health approach that meets WHO definitions of primary health care.
1. Y. Madhavi, et al., ‘Evidence Based National Vaccine Policy – Policy Document’, Indian Journal of Medical Research 131, 2010, pp. 617-628.
2. C. Sathyamala, et al., ‘Polio Eradication Initiative in India: Deconstructing the Global Polio Eradication Initiative’, International Journal of Health Services 35(2), 2005, pp. 361-383.
3. J.M. Puliyel and Y. Madhavi, ‘Vaccines: Policy for Public Good or Private Profit?’ Indian Journal of Medical Research, January 2008, pp. 1-3.
4. D.L. Pelletier, et al., ‘The Effects of Child Malnutrition on Child Mortality in Developing Countries’, Bulletin of the World Health Organization 73(4), 1995, pp. 43-48.
5. C. Hamlin, ‘Could You Starve to Death in England in 1839? The Chadwick-Farr Controversy and the Loss of the "Social" in Public Health’, American Journal of Public Health 85(6), 1995, pp. 856-866.