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Vaccinating Infants: The Risk To India's Newborns

A sly fudging of facts is pushing India into buying vaccine backed by the WHO that may may have killed children in other countries.

BABIES, THEY say, are a nice way to start people. They are also, it would appear, a nice way to start profit. If the babies are Indian, there’s added allure to the profit because there are so many of them every year. In the days to come, as the denouement of a series of extraordinary events, the Indian government is expected to make a fresh decision on the number of vaccines Indian infants are to be given soon after birth. Much rests on the decision for Indian families and, oddly, the World Health Organisation (WHO), which has made a bizarre push for new vaccines it wants Indian newborns to be given in the country’s public health programme.

A decision one way could risk the lives of the country’s babies, because there are doubts on the quality of vaccines the WHO is pitching for; it could push the government into financial commitments it is in no position to meet; it could empty the pockets of people who seek private medical help, and put the nation’s health sector more firmly under the control of agencies outside India. A decision the other way could force units formerly run by the Indian government to resume full work and make homegrown vaccines; and thrust more expenses on a feeble state wallet, which will need to fund more R&D.

This vaccine soup has been stirred by the WHO, which is in the midst of several controversies of late for creating medical scares and then backing drugs to fight them. In the first week of June, the WHO admitted it had failed to disclose conflict of interest for scientists who advised it on the H1N1 influenza pandemic. The response came after a British media report said the WHO had announced a fake pandemic to boost sales for pharmaceutical companies that manufacture antiviral drugs and the H1N1 vaccine. Now, there appear to be the makings of a similar controversy over what may be taking the shape of an Indian vaccine scam.

The Vaccines
India does not have a well-defined vaccine policy. It has a National Immunisation Programme, under which it conducts an Expanded Programme of Immunisation (EPI). Twenty-five million children are born every year in India. That is a vast vaccine market, far bigger than many countries put together. Only about 53 percent of the children born in India are vaccinated. This means about 11 million children in India, almost wholly from poor families in the hinterlands, still need to be vaccinated every year.

Also, only about 40 percent of the children are born in medical institutions. Here, there is a process laid down for vaccination. A whopping 60 percent of annual Indian births, or 15 million, are in homes or anywhere else. Most of them, in the villages and backwaters of India, are not likely to get vaccinated. Eighty-five percent of all vaccination in India is done by the government. The private sector accounts for the other 15 percent.

India’s EPI covers six primary vaccines: BCG, Bacillus Calmette-Guérin, a vaccine for tuberculosis; DPT, also called the trivalent vaccine, for diphtheria, pertussis (whooping cough) and tetanus; DT, a diphtheria and tetanus vaccine given to children with adverse reactions to pertussis or where there is a family history of seizures or brain disease; TT, tetanus vaccine normally given as DPT or also separately; measles; and polio.

For millions of parents, this is a moment of absolute helplessness. They have created a life and will take no chances with its protection. They will do anything for the newborn. They are like fodder. Those who can afford the private clinics end up paying far more than they should. The private clinics run their own vaccination programme that may differ from the national immunisation policy. For instance, many clinics offer hepatitis B and Hib (Haemophilus influenzae Type B) shots though they are not part of the national programme. This package can cost between Rs 1,500 and Rs 4,000. Doctors in the know say the profit margin is huge. The pharma companies send the pentavalent vaccine to the doctors at, say, Rs 1,000. The MRP might show, say, Rs 525, or even Rs 2,200 depending on the manufacturer. The doctor adds consultation fee, nurse costs, syringe costs and so on.

Those who go to government centres get the shots free. But, for both the rich and the poor, life revolves for a while around the vaccine shots. A child gets BCG and polio shots at birth. This is followed by DPT shots in the sixth, tenth and fourteenth weeks. Measles vaccination is done between nine months and 15 months. Then, there are DPT and polio doses at 18 months and four-and-a-half years. This is the routine a parent and child go through.

The WHO is entering this landscape and is pushing for an expansion of the trivalent DPT vaccine into a pentavalent vaccine by including two other diseases, hepatitis B and Hib, based on motives and theories that are being questioned. Switching to pentavalent would force India to shut its public sector units and depend entirely on the pricing whims of the private sector.

The Cost
The WHO push for a pentavalent vaccine in India’s public health policy is based on two arguments: that Hib and hepatitis B exist in India to an extent enough for public vaccination, and that the pentavalent vaccine works in other countries, notably Asian nations like Sri Lanka and Bhutan, in the same geographic zone as India.

This is being seen by Indian experts as an attempt to market vaccines manufactured by big pharmaceutical companies like GlaxoSmithKline Pharmaceuticals Limited, by creating a fake scare of hepatitis B and Hib in India. There is a huge cost factor to this. The WHO is seeking an amendment in our public health policy on immunisation. This means the government will have to pay for the pentavalent vaccine when it has no money.

This is a perpetual expense as children are born all the time. Currently, the Indian government procures the trivalent vaccine at around Rs 15 from Indian firms. The WHO-backed pentavalent vaccine will cost Rs 525 at UNICEF-negotiated prices. Then, there will be additional costs for handling and delivering , which makes the pentavalent vaccine 35 times costlier than the trivalent vaccine. That is Rs 735 crore in cost of vaccine alone in perpetuity every year, and increasing due to inflation.

Appallingly, there is no concern for the 11 million or so Indian children who are not vaccinated because they are too poor to afford private care, and because the government has not yet established systems to reach them. So, while a massive number of children are already suffering, the push for a pentavalent vaccine only increases costs of existing vaccines.

“Why should we go for something that is 35 times costlier when we are unable to even administer the existing vaccines? There is much greater burden in India of diphtheria, tetanus and pertussis (whooping cough) compared to hepatitis B and Hib. Cases of diphtheria are rising in India and we haven’t yet got a grip on child mortality. Why then are we even considering the pentavalent vaccine?” says Dr Sanjeev Singh, an advisor to several hospitals in Delhi and who has worked in preventive and social medicine.

Singh says India’s trivalent vaccine is failing because of several reasons that need urgent attention. “Vaccines need to be maintained at a specific temperature. They go from a pharma company to the government of India, which then sends them to state governments. From here, the vaccines are sent to district centres and from there to primary health centres and anganwadi workers who carry them to homes. We do not have a cold chain system that can keep the vaccines at the temperature they need. So the vaccines fail. This is a top priority area. Then, we don’t have enough doctors, nurses and other workers. Those we have are not trained well. This is a disaster that needs immediate investment of money and skills,” says Singh.

Somebody needs to make the pentavalent vaccine on a scale that India needs, should the WHO convince the Union government to go for it. The Indian firms that make the trivalent vaccines have only recently reopened under pressure from a group of concerned experts after they were shut by the first government of the United Progressive Alliance (UPA). Now, the WHO wants hepatitis B and Hib vaccines added, which these Indian firms have no expertise at making. This is where the friends of the WHO, organisations and companies based largely in the US, come in. It is most likely that the pentavalent vaccine will then come from agencies and companies outside India. This is worrisome.

The Deaths
The economic burden of a pentavalent vaccine is a bother, but less so when seen in the light of what happened in Sri Lanka and Bhutan, where the WHO got the governments to use a pentavalent vaccine. In Bhutan, the government stopped the use of the pentavalent vaccine just two months after it was introduced. In late October 2009, the Bhutan health ministry sent an urgent circular to various centres and clinics saying: “The use of pentavalent vaccine should be stopped immediately due to some side effects. All adverse events following immunisation (AEFI) must be reported and investigated.”


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