Speaking about his debut book Heavy Metal: How a Global Corporation Poisoned Kodaikanal, environmentalist and journalist Ameer Shahul told Article 14 in April 2023 about a significant shortcoming in health systems where doctors may be unable to diagnose symptoms including serious neurological diseases as related to mercury poisoning.
In Vaccine Nation: How Immunization Shaped India, Shahul returns to questions of public health, this time exploring the intersections of human health, scientific endeavour and public policy.
From the battles against cholera and plague to the mass campaigns against polio,
tuberculosis and measles, the book tracks major milestones including Waldemar Haffkine’s pioneering work in 1893, the contributions of scientists including Shanti Swarup Bhatnagar and Sahib Singh Sokhey, the founding of the Serum Institute, the creation of COVAXIN and COVISHIELD, and the emergence of India as a vaccine provider for the Global South, in defiance of global pharmaceutical monopolies and resource-constrained public health systems.
The book also examines the challenges faced by India in maintaining a humanitarian approach to public health in a world where healthcare is increasingly privatised.
‘Not many people realise or appreciate how India has become the largest producer of high-quality vaccines used globally, or how starting in the twentieth century until the present, India blazed a trail in vaccine science and innovation,” says vaccine developer Peter Hotez, in advance praise for Shahul’s latest. Hotez, author of The Deadly Rise Of Anti-Science and Preventing The Next Pandemic, says: “Vaccines rank high among India’s gifts to the world, but they did not arise by accident.”
Vaccine Nation is the story of how India achieved that status.
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Excerpt
In the winter of 1967, in Vellore – located midway between Bangalore and Madras – Thekkekara Jacob John found himself faced with a medical mystery. In his out-patient department at the Christian Medical College he had noticed a few cases of children who, despite taking three doses of trivalent oral polio vaccine (tOPV, Sabin), were falling victim to the virus. He began passively investigating the case and assumed that it was possible that these cases indicated the failure of vaccines. Known in medical circles as ‘vaccine-failure polio’, such cases had not yet been documented in countries where tOPV was widely used, be it in North America or in Europe.
Polio was rampant in India at the time, with around 500 cases being reported daily on average. Armed with an MRCP in Paediatrics, a fellowship in paediatric infectious diseases and a post-graduation in microbiology from Denver, Colorado, John was drawn into the thick of it. He quickly shifted his focus from his clinical practice to the realm of public health and epidemiological studies, spending much of his time with local communities and civil society.
Soon after setting up the Enterovirus Centre in 1964, the Christian Medical College in Vellore carried out a longitudinal community survey in the area and found subclinical poliovirus infection in 242 of 1,000 children below five years of age. Another study in the nearby village helped establish that the prevalence of poliovirus was found to be higher in urban areas compared to rural communities. These studies, along with research in places like Bombay, revealed that the country had a high prevalence of both poliovirus infection and paralytic poliomyelitis.
In fact, the incidence of paralytic polio in India was among the highest anywhere in the world, with a significant number of cases occurring in infants below six months of age. The findings suggested a high frequency of transmission, especially through respiratory means, contributing to the polio burden of the country. Despite this dire situation, efforts to control polio received limited attention from the Government of India which was responsible for earmarking and devolving funds for its control and eradication.
Meanwhile, the government was focused on diseases like tuberculosis, malaria, leprosy and kala azar. This negligence continued for a while, despite the fact that IPV had been available since 1955, and OPV since 1962, with demonstrated safety and efficacy. It was only in 1964 that OPV was introduced in the country, first in
Bombay and then in Vellore.
However, OPV came with its own set of problems – it did not deliver the promised immunogenic efficacy and vaccine efficacy, as was shown in the clinical studies. Despite being administered three doses of OPV, some children contracted the polio infection. These were the cases John began investigating in 1967.
Various reports of children developing poliomyelitis continued to come from other parts of the country as well, reflecting poor vaccine efficacy. In 1970, the first definitive study on the problem of low immunogenic efficacy of the OPV with standard potency was published by John, who had made it his life’s mission to eradicate polio from the country. Studies from Delhi and Bombay also indicated low immunogenic efficacy.
Warnings about the poor efficacy of OPV in India were evident years before the 1978 launch of the Expanded Programme on Immunization (EPI). This WHO-driven campaign aimed to reduce fatalities from diseases like diphtheria, pertussis, tetanus,
poliomyelitis and tuberculosis through effective vaccination. In contrast, during clinical studies, IPV had demonstrated excellent Vaccine Effectiveness (VE). Since 1955, IPV had been successfully employed in the US, Canada, the UK and several northern European countries, resulting in a rapid and substantial reduction of over ninety-five per cent polio cases. Finland successfully interrupted the transmission of Wild Poliovirus (WPV) in 1962 by utilizing IPV campaigns. India confronted a dilemma as to which vaccine would most suit its needs.
Deploying IPV presented yet another challenge, as it had not been licensed for use in the country. In 1985, a manufacturer who attempted producing IPV under a state license in Maharashtra was forced to stop production after a directive from the Government of India. It was not until 2006 that IPV was licensed and its potential to be the vaccine of the future was acknowledged.
OPV had a much longer history in India. Back in 1966, responding to a specific request from India, Albert Sabin generously contributed his vaccine strains to the Pasteur Institute in Coonoor, almost six years before donating the vaccine seeds to WHO. He went a step further by personally training the institute’s staff and ensuring the establishment of an OPV manufacturing unit in the world’s second most populated country. This initiative led to the successful production of six batches of OPV. However, rather than expanding its manufacturing capacity, the OPV unit was unexpectedly shut down in 1974.
This unfolded at a time when WHO was devising strategies for the widespread use of OPV as part of the EPI in India. The discontinuation of production of OPV in the country meant that it had to be imported for use in EPI. Consequently, the introduction of OPV under EPI experienced delays and when it was rolled out, it was confined to urban areas between 1979–80 and was extended to rural communities only two years later.
Beyond OPV’s availability, the country’s vast size and mobile population made polio vaccination daunting. With 27 million babies born annually and millions traveling daily on passenger trains, the risk of virus transmission remained high.
During this period, virus outbreaks had been rippling through neighbouring countries of Bangladesh, Nepal, Tajikistan and countries in Africa. The intricate web of poor sanitation, high population density, sub-par health conditions and the relentless onslaught of heat and monsoons – conditions that India too was battling with – were proving to be a breeding ground for the virus. Therefore, when the vaccine was introduced as part of the EPI, the stage was set for an extraordinary battle against a formidable adversary.
Amid these ambitious efforts, a new challenge emerged. In the western reaches of Uttar Pradesh, unverified rumours began circulating that the vaccine was ‘haram’ for Muslims and would sterilize boys, sowing seeds of distrust.
However, the most critical challenge arose from a short-sighted approach by the health policy makers. Since OPV was not immediately available in the country, the EPI commenced with the administration of DPT and BCG vaccines which were being produced by public sector companies. This strategy had overlooked the well-known fact that DPT vaccination given without a polio shot had the potential to trigger poliomyelitis. In a country with a high prevalence of polio, the introduction of DPT inoculation without prior polio vaccination created a man-made crisis that led to the loss of many million lives.
According to annual EPI reports that tracked vaccination progress against a total of 29 million children receiving DPT injections over the four-year period from 1978, only 4.4 million children received three doses of OPV. This glaring discrepancy set the stage for what seemed to be the world’s largest iatrogenic outbreak of poliomyelitis in India during the early 1980s.
Despite including OPV in the EPI, the incidence of polio cases persisted for a decade with two conflicting forces at play – the decrease in cases due to OPV and the increase caused by DPT. Amid these conflicting trends, a nationwide polio epidemic erupted in 1981 in the middle of an already hyper-endemic situation. That year alone
saw over 38,000 reported cases, and the final tally was pegged at almost 200,000 cases. John, in a study jointly performed with his colleagues from the CMC, assessed the national productivity loss from this catastrophe at Rs 450 billion.
Through the seventies and eighties, new polio cases continued to surface among children who had already received three doses of OPV, indicating poor vaccine efficacy. In a sample study conducted by John in the Vellore region, the incidence of vaccine failure rose steadily – from ten per cent in 1979 to thirty per cent in 1986, and further to fifty per cent by 1989. In response, health authorities implemented various strategies to address the issue, including a prime-boost approach by administering additional doses.
Based on his trials involving the administration of five doses in infancy, which aligned with the five infant-contacts in the EPI with other vaccines, John proposed a five-dose strategy. However, the Ministry of Health dismissed his suggestion, adhering to the three-dose rule, potentially endangering many young lives.
Undeterred, John explored alternatives, including the use of IPV, which demonstrated predictability and complete protection. Surprisingly, the Ministry of Health did not grant license for IPV in the country.
John then proposed the concept of pulse polio vaccination campaigns, a strategy that could potentially control polio. Pulse vaccination, he argued, could disrupt the balance between the vaccinated and the susceptible children at a specific point in time, impeding the ease of transmission of wild polio virus (WPV). However, despite its promising potential, the Ministry of Health, yet again chose not to approve the vaccination campaign.
To circumvent governmental apathy, John drafted a pathbreaking collaboration with the Rotary Club of Vellore and the Vellore Municipality which led to the birth of pulse polio campaigns. The town was strategically divided into sixteen zones, each with a designated station for administering OPV. The campaign was to inoculate children below four years of age with three doses, strategically spaced at monthly intervals, ending towards the end of 1981. The community was mobilized through slide presentations in cinema halls, newspaper announcements and widely distributed handbills.
This was not just a routine vaccination – it was a community- wide endeavour fuelled by a shared vision of a polio-free future. Each campaign spanned four half-days, with four stations operating simultaneously, manned by volunteers from the CMC and municipal health centres. The impact of the campaign was monumental. To assess its reach and effectiveness, a thirty-cluster sample survey was conducted in February 1982, strictly following WHO-recommended methods. The results were nothing short of a triumph, with a remarkable 62 per cent of children in the catchment area receiving three doses of the oral polio vaccine.
John’s strategic vision and collaborative approach proved that polio could indeed be controlled in small geographical units. Vellore became a beacon of hope and resilience, demonstrating that a community could, on its own, overcome a seemingly insurmountable challenge with hard work and cooperation. The success story echoed
far beyond the town boundaries, inspiring other communities to embark on their own journeys toward a polio-free future. John’s Vellore pulse polio campaign set a precedent for effective community-based health initiatives, leaving an indelible mark on the fight against polio in India and in the developing world.
(Excerpted with permission from Vaccine Nation: How Immunization Shaped India , published by Pan Macmillan India.)
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