Much ado over vaccines

Osama bin Laden isn't dead. Global warming is a hoax. NASA faked the moon landings. Vaccines cause autism. And Bill Gates?

On Wednesday, February 7, conspiracy theorists had a field day when a report emerged: 'Centre shuts health mission gate on Bill & Melinda Gates Foundation'. At the heart of it was a Big Money, Big Pharma, Big Corruption plot: how the biggest philanthropic organisation in the world was "influencing" India's vaccination strategy, to the advantage of global pharma giants.

The government's decision to snap ties with BMGF was, apparently, informed by "arguments from senior medical professionals and outfits like the Swadeshi Jagran Manch".

Instantly, the news went viral, resounding across domestic and international media.

The 23 members of the country's highest advisory committee on immunisation-the National Immunisation Technical Advisory Group (NTAGI)-scratched their heads in bewilderment. And the Union ministry for health, with three of its seniormost bureaucrats co-chairing the NTAGI, kicked into overdrive: the vaccination strategy, after all, was one of Prime Minister Narendra Modi's flagship projects.

The very next day, on February 8, a press note was released: that the reports were "inaccurate and misleading"; that there was no financial link between NTAGI and BMGF; that the latter continued to "collaborate and support the ministry".

The news comes at a time when India is trying to take its basket of free vaccines for children towards the international standard, after years of remaining static.

The prime minister himself has been seeking support from Bill Gates - technocrat, philanthropist and the world's wealthiest man - for his ambitious Universal Immunisation Programme.

Four new vaccines have been rolled out across the country this year (see Pipeline Perks Up), recommended by the NTAGI and with product support of the Global Alliance for Vaccines and Immunisation (GAVI)-an international non-profit partnership, backed by Gates, that works to ensure affordable access to essential vaccines to 73 low- and middle-income countries of the world, backed by Gates.

"Conflict of interest generally refers to when someone participating in a decision-making process seeks to have a decision made that enhances their best interests in some way, usually a financial benefit," says K. Vijayraghavan, scientist and secretary, Department of Biotechnology, health ministry.

"At the NTAGI subcommittee, we ask all members to declare their conflicts of interest and this is done. The policy we follow is similar to that of WHO."

The Big Money, Big Pharma, Big Corruption plot just doesn't work, adds Dr Soumya Swaminathan, secretary, Department of Health Research, health ministry.

To begin with, the NTAGI is not a 'body', but a committee of some of the best scientists, public health experts and civil servants in the country, who take decisions in their independent capacity.

The BMGF may have "big money", but it is not represented in the NTAGI. And as the largest vaccine manufacturers in the world, India itself is 'big pharma'. "If our strategy can be influenced, what does it say about our expertise, intelligence or integrity?" asks Dr Soumya.

And it raises the biggest question of all: the fate of India's under-immunised children, half a million of whom die of vaccine-preventable diseases every year. "We have a long way to go to protect our children," says Vijayraghavan.

"India gives vaccines against eight diseases nationally, whereas the US offers vaccine against 16 diseases." India needs to more than quadruple its spending on vaccines to protect children.

And, Gates, as an international donor, is key in fulfilling that requirement. "Conspiracy theories, without any evidence, can greatly harm the immunisation programme," adds Dr K. Srinath Reddy, president of the Public Health Foundation of India in Delhi.

It's a familiar image: a mother holding a scared, bawling child, while a smiling health worker forces red polio drops down its throat. An essential rite of passage: routine immunisation. First adopted in 1978, with vaccines against tuberculosis, diphtheria, whooping cough, tetanus and polio, India has been carrying on with pretty much the same basket.

In 1985, with the measles vaccine added, it got a new name: Universal Immunisation Programme. Yet, 32 years later, of the 27 million babies born each year-more than in any other country-just 62 per cent are fully fortified with vaccines, the rest are at risk of at least 13 life-threatening infections because they are unimmunised or partially immunised. In contrast, 90 per cent of two-year-olds in India's much poorer neighbour, Bangladesh, are fully immunised.

"Vaccination has not been a really regulated thing in India," says Dr Jayaprakash Muliyil, epidemiologist and former principal of the Christian Medical College in Vellore. Take rubella, for instance. "It causes the silliest disease in the world," he says, similar to measles, but very mild and transient. "But if you get it in your reproductive age, and you happen to be pregnant, the baby comes out with abnormalities."

India had rubella outbreaks about every seven years, everybody got infected and immune. Things changed with the coming of the expensive measles-mumps-rubella vaccine (MMR) in the private sector in the cities, he explains.

The cycle of outbreaks got delayed and started affecting poorer women of child-bearing age in urban areas, who did not have the vaccine, leading to congenital defects.

The vaccine, long resisted by the government, has now been made part of routine immunisation. "Vaccination can harm if not done well. And you need a body that can give you advice and direction," says Muliyil. The NTAGI was streamlined to serve that purpose.

Layers Of Experts

It was only in 2013 that the NTAGI was reconstituted, under the then health secretary Keshav Desiraju. NTAGI is not a body, but a coming together of some of the best scientists, public health experts and civil servants in the country, in an advisory capacity, with no executive function.

A technical subgroup was created within it. "To avoid criticism that decisions involving scientific matters were being taken by administrators, it was decided that all issues coming to the NTAGI for decision would be examined by the subcommittee," explains Desiraju.

Even today, the subcommittee reviews immunisation progress, the evidence base for new vaccines, safety, effectiveness, cost benefit, burden of disease and provides inputs to the full NTAGI, which then sends its recommendations to the health ministry to take the final call.

Within the NTAGI, there is the Immunisation Technical Support Unit (ITSU), which is the NTAGI's secretariat, a 3-member team of a 60-member staff strength, managed by the Union Health Ministry. On the request of the ministry, BMGF funded PHFI to set up the ITSU. The location outside the ministry was considered correct, as the ITSU functions in a secretarial capacity to the NTAGI, but also handles data, especially related to adverse reactions in clinical trials, says Desiraju.

The choice of PHFI was because of its reputation. ITSU was funded by the Gates Foundation, only in order to ensure higher standards and quality of work. "It meant, we could pay better, get more people and better people," says Desiraju. The ministry has been working toward the takeover of ITSU for quite some time. And this has been reported as the "snapping of ties".

CONFLICT OF INTEREST

Nachiket Mor, the Country Director of BMGF in India, was surprised when the news item came out. "That BMGF is driving international pharma is complete nonsense,"he says. "The new vaccines introduced successfully by the government are local vaccines, developed by and in India."

The vaccine industry has earned India the recognition of having the largest global capacity, supplying nearly 60 per cent of WHO prequalified vaccines across the world, according to GAVI data.

"It was the Government of India that decided to introduce a number of new vaccines into the country, Mor explains. "The NTAGI is run by the government, owned by the government, financed by the government. It does not have relationship with anyone."

What they needed was technical support-a group of people who would understand vaccines, their rollout, the supply chain, the adverse events, and assemble all the data. This is what the ITSU did, with BMGF support.

Ever since Bill and Melinda Gates established the lavishly funded charity in 2000, it has spent over $36.7 billion on improving global health. In India, the BMGF has worked on vaccines in polio, childhood and maternal mortality, HIV, sanitation, in large projects in Bihar and Uttar Pradesh.

The new rotavirus vaccine for diarrhoeal diseases in children was rolled out this year. It can save 70,000 lives a year, and has been developed in India by Bharat Biotech, with financial support from BMGF. "We don't see ourselves as permanent players in India. Our role is that of time-bound support," says Mor.

The money required to immunise every child in India is not large, he explains, about Rs 6000-7000 crore per year. "India has the money, the vaccines, the supply chain. It's just a matter of handholding. I am very optimistic that in 2-3 years, the government can do it on its own."

SOLITARY SCEPTIC

In the meantime, the first phase of ITSU has come to an end. Discussions have started with BMGF for the second phase of the work. "PHFI is carrying out the mandate given to it by the Union ministry for health," says Dr Reddy, "which is providing technical assistance.

It will continue to do so in support of the very important national programme, which is the painless saving of child life."

But the NTAGI is also looking within: for vaccine sceptics, conspiracy theorists, people who could have reached out to journalists and fed them with bogus reports and statistics.

For the last two years, such stories have come up every six months, members now say: sometimes it's Bill Gates and his shares in MNCs, sometimes on MNCs pushing vaccines to the government, sometimes ineffectiveness of the decisions taken by the NTAGI. "We must keep in mind that gratuitous and unfounded allegations are thrown around by some misplaced zealots," Vijayraghavan points out.

"We all have the right to hold our views and the right to a space to air them. Yet, if fear-mongering and baseless claims are not subjected to the same rigour of examination as rigorous science, we have a serious problem."

Vaccines save lives. Those who endlessly block decisions, even after rigorous evaluation at every stage, and do so with specious and untenable arguments must be held to rigorous standards as must be everyone else.

Because, at the end of the day, endless delays cost lives. And it is not just a matter of journalistic debate.