The problem

IT has been 35 years since 1977, when the world observed the last recorded case of naturally occurring smallpox. We had finally defeated a disease that had devastated mankind for centuries. It was a critical victory for the many doctors, scientists and health workers who laboured tirelessly to eradicate this terrible disease. It clearly demonstrated what a resolute immunization campaign could accomplish with support from the global community and local governments. However, most of all, it was a validation of one of greatest advances in modern medicine – vaccines.

In a sense, 2012 has the potential to be an equally important milestone. As of January, it has been more than 12 months since India recorded its last case of poliomyelitis. If 2012 passes without this record being disturbed, India – and the rest of the world – would have made significant progress toward eradicating only the second human disease ever. As with smallpox, the primary tool that is being employed is a highly effective vaccine. It is because of their tremendous public health value that the famed economist Jeffrey Sachs once called vaccines and other similar health interventions ‘weapons of mass salvation.’

This potentially defining advance in the battle against polio comes, coincidentally, at a moment of reckoning for vaccines and immunization. In May 2011, the Decade of Vaccines Collaboration was launched at the World Health Assembly. With a variety of stakeholders – ranging from United Nations agencies to multilateral bodies, national governments to philanthropic institutions – this effort hopes to maximize the power and potential of vaccines over the next decade, and expand the full benefits of immunization to everyone.

The next five to seven years will also see a rapid expansion in the number of vaccines that will become available to medical practitioners and public health programmes. This is particularly remarkable, as many of these new vaccines will protect against diseases that have not yet been fully controlled by other prevention and management strategies. Taken together with global efforts such as the Decade of Vaccines Collaboration, the next 10 years could see more progress than any previous decade towards addressing several pressing public health concerns. We now have an opportunity here in India to contribute to and dramatically impact global immunization efforts. At the same time, many challenges will need to be overcome within the country.

Efforts to address child health take on a new sense of urgency looking at the striking health statistics. Each year, the world loses eight to nine million children less than five years of age; India accounts for a disproportionate one-fifth of these deaths. Diarrhoea and pneumonia are the leading causes of death in the country, together accounting for nearly one-third of all child deaths. Pneumonia is responsible for more than 300,000 deaths among children less than five years of age. Equally astounding is the fact that more than 120,000 Indian children in the same age group die from diarrhoea related causes each year. The country with the second greatest burden is Nigeria, which has less than 50,000 deaths per year. China, with a population larger than India’s, loses only 27,000 children to diarrhoea.

There are also specific immunization challenges that need to be addressed. India has the largest number of unimmunized children in the world. Full immunization coverage currently stands at approximately 60 per cent. It has been encouraging to see the government pour so many resources into addressing these worrying figures. However, more needs to be done. It is, therefore, appropriate that the government has called 2012 the ‘Year of Intensification of Routine Immunization.’

Also troubling is the fact that many newer vaccines are currently available through largely private health providers. As a result, it is often only the richest among us who can afford to protect their children with these powerful and proven tools. This is unacceptable for one of the fastest growing economies in the world. It is an especially unfortunate reality when one considers that Indian vaccine manufacturers produce a majority of the low-cost, high-quality vaccines used in internationally funded immunization programmes throughout Asia and Africa. It is an injustice of the highest magnitude that vaccines manufactured in India are saving countless lives around the world, while these same lifesaving vaccines are denied to India’s poor.

Historically, as countries grow wealthier, they have more resources to invest in public health programmes, including immunization and other prevention or treatment interventions. There is significant positive movement in this direction in India. In recent years, there have been several discussions around the availability of data needed for decision-making. Experts increasingly agree that there are sufficient data to justify the introduction of some of these newer vaccines. As such, India recently initiated plans to expand the Universal Immunization Programme (UIP) by introducing the second dose of the measles vaccine, as well as the pentavalent vaccine, a combination vaccine that protects against five causes of disease – diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type b (Hib).

India is lucky in that it has a strong and innovative scientific community. For example, several promising vaccine candidates are being developed by Indian companies that could potentially protect Indian children against one of the leading causes of severely dehydrating diarrhoea – rotavirus. One of these vaccines could be available within the next one or two years. Studies have demonstrated that rotavirus vaccines would reduce the high burden of diarrhoeal disease in India.

How will India utilize, tweak and deploy these technologies? The answers will define the future of immunization in the country, and elsewhere. As Sam Pitroda, policymaker and advisor to the prime minister on innovation, describes in an interview in this issue, India’s great quest is to migrate from an ecosystem that has not allowed it to be a ‘big inventor of vaccines’ to realizing the ‘interesting promise that now exists for indigenously developed vaccines.’

Indeed, there are countless opportunities for innovation. Using text messages to send immunization reminders to parents and potentially using the Unique Identification (UID) database to track vaccine recipients are just a couple of examples that have been considered in recent years. Utilizing these kinds of technologies will only help to extend the lifesaving benefits offered by increasing access to existing and new vaccines.

For the people who read Seminar, vaccines are often taken for granted. It is easy to miss their game changing potential. In fighting and reducing the burden of infectious diseases, vaccines are among the most effective interventions available. Some calculate they prevent six million deaths globally each year. The annual return on investment is estimated to be between 12 and 18 per cent – better than the best interest rate a bank can guarantee!

Even these numbers may be too low. As the economist Bibek Debroy asks in his contribution to this volume, ‘Why is immunization important?’ He answers the question by elegantly linking this basic public health intervention to its wider socioeconomic impact. ‘Immunization,’ he writes, ‘… is more than an end on its own. Reduced under-five and infant mortality has correlation with levels of economic development and with India’s promised demographic dividend.’ If vaccines are not made available for vaccine preventable diseases, children could experience both mortality and morbidity. These consequences have both an emotional and financial impact on the family and potentially drain scarce resources in society.

It is not just a question of economics, though. Immunization and vaccination are fundamental to several aspects of our lives, including the communities we comprise and how we travel. Increasing international travel means that disease and infection can travel further and more quickly. Bacteria and viruses, after all, do not need visas to cross borders. There is the point of view, expressed recently by Princeton University academic Petra Klepac suggesting that a country aiming to achieve herd immunity may benefit by the success of a neighbour that has near universal immunization, as this would reduce the risks from visitors. In addition, many vaccines that are now available, including Hib, pneumococcus and rotavirus vaccines, have a strong, ‘herd effect’. Thus, even in communities where only 50 to 60 per cent of the population is immunized, a majority of the disease will disappear.

Given this, India’s future polio challenges are less likely to be domestic than emanating from other South Asian countries that may still not have controlled the polio virus. There are other examples as well. The hosts of the Haj pilgrimage require devout Muslims who visit the holy city of Mecca to give evidence of certain vaccinations. Likewise, in January 2013, millions of visitors from across India and other parts of the world will gather in Allahabad for the Mahakumbh. It is important that appropriate vaccines are provided to this population in order to prevent epidemics of disease from occurring.

It only takes one case to raise an alarm. In 2000, the United States was declared free of measles. Five years later, a lone teenaged visitor from Romania, unvaccinated against the disease, arrived in the state of Indiana. She triggered America’s worst measles outbreak in more than a decade.

A global threat of this scale requires a global response. Here the mandate and actions of the GAVI Alliance merit attention. As Seth Berkley, the recently appointed CEO of the global partnership, explains in an interview for this issue, ‘GAVI has contributed to significant increases in immunization coverage among children in poor countries. The result is that many developing countries now have similar immunization rates as richer countries or, in some cases, have even surpassed them. But reaching the last 10-15 per cent of children is very hard. Often they are among the poorest of the poor.’

The greatest need for immunization is felt among the ‘poorest of the poor’, as Berkley says. Here in India, the tribal communities are among the most difficult to access and immunize. In my work in the United States, I found a grim and poignantly similar situation while living among the White Mountain Apache and Navajo people, a Native American community residing predominantly in the states of Arizona and New Mexico.

I first went to the White Mountain Apache community in the early 1980s and researched a diarrhoea epidemic caused by rotavirus. Children were suffering and the numbers were so large that the hospital at the reservation could not cope. It was truly a health emergency. The team I led sought to improvise and demonstrate that a majority (more than 90 per cent) of cases of dehydration as a result of diarrhoea could be treated with a modest mixture of salts and sugar known as oral rehydration salts (ORS). This simple intervention can be the difference between life and death for a child with diarrhoea. The situation that I experienced on the reservation was reminiscent of what I experienced in India during my medical training.

Today there are two efficacious rotavirus vaccines that are licensed and approved for use in many countries around the world. Several Indian companies are currently evaluating indigenously developed vaccine candidates. It is critical to ensure these vaccines reach those who need them most, whether Native American children in Arizona or young residents in a remote Gond village in Chhattisgarh.

It was among the Native American people as well that I studied the implications of Hib meningitis. Thousands of children die each year from meningitis, and a significant proportion (30 to 40 per cent) of those who are lucky enough to survive can develop severe neurological complications. My work among the Apache and Navajo populations contributed to the evaluation and the subsequent licensure of a Hib conjugate vaccine called PedvaxHIB. After that vaccine was introduced, Hib meningitis more or less vanished from among the White Mountain Apache and Navajo people, and later from the United States altogether. I believe strongly that this can be achieved in India as well.

In this context, I very much appreciate Altaf Lal’s analysis on how emerging powers such as Brazil, China, and India approach immunization decisions and make choices about introducing new vaccines through national immunization programmes. It is informative as well as educative. These countries could learn from each other, and other low and medium income countries could learn from them.

Unfortunately, the success of vaccines has also bred complacency. I ascribe this to several of the controversies that have dogged immunization programmes. Polio programmes in countries as far apart as Nigeria and India were affected and delayed due to misperceptions about the polio virus among some religious groups. In India, thankfully, these were addressed with help from faith-based leaders from the community. This has not been an isolated case. Misinformation around vaccines has been a cause for concern across the world. In a few countries, such misinformation has led to a fall in vaccine coverage and caused a re-emergence of diseases such as pertussis and measles and resulted in thousands of deaths.

Part of the reason for such arguments is some posit the debate in ‘either/or’ terms, and see critical issues as either black or white. In reality, vaccines are most effective when used as a part of a comprehensive approach. As N.K. Ganguly, the noted public health specialist and former Director-General of the Indian Council of Medical Research (ICMR), says, ‘Although vaccines are a critical component of disease prevention strategies, vaccines alone cannot tackle the high burden of diseases, especially in developing and highly populated countries. There is a growing need to deploy a combination of available strategies. A weak health system coupled with enormous population, spread over diverse geographical regions, makes achieving these goals difficult. Comprehensive disease prevention interventions that include strategies to protect, prevent, and treat high burden diseases are needed, along with improvements in the health system.’

When the World Health Organization introduced the Expanded Programme on Immunization (EPI) in 1974, it essentially attempted to push the use of a set of vaccines in poor and developing countries that had weak public health infrastructure. There was a feeling that if numbers were reached, and more and more children were vaccinated, the wider goal of disease control would automatically be achieved. This hasn’t quite fallen into place. Vaccines cannot entirely substitute for a weak or absent public health infrastructure. A comprehensive childhood disease control programme requires multiple elements within a public health system that delivers results. Vaccination and immunization is only one of these elements. It is critical that appropriate treatment modalities are also made available to every child.

India has come a long way since independence and the last case of smallpox. Just three decades ago, nearly four million children less than five years of age died in India each year. Today, that number has been reduced to 1.3 million. While this is a truly remarkable achievement, there are still roughly 3,500 child deaths each day – simply far too many. We have the tools to bring down this number even further. Vaccine preventable diseases cause a significant proportion of these deaths. Unnecessarily delaying the introduction of new vaccines that prevent against Hib, pneumococcus, and rotavirus puts countless lives at risk. In the words of Martin Luther King Jr, ‘The clock of destiny is ticking out, and we must act now before it is too late.’

 

MATHURAM SANTOSHAM