Global push

Vaccines that may not be necessary may become part of Indias immunisation programme and create a new market for global companies.

THE Global Alliance for Vaccines and Immunisation (GAVI), an alliance of public and private stakeholders ostensibly committed to saving childrens lives worldwide, organised a meeting in New Delhi on March 7 where the decisions taken had nothing to do with the core issue that concerns the lives of millions of Indian children, namely, the strengthening of routine immunisation (RI) under the governments Universal Immunisation Programme (UIP), which, unfortunately, has a coverage of only about 40 per cent.

The UIP aims to protect children against six diseases through vaccination with three doses of the DPT (diphtheria-pertussis-tetanus) vaccine and OPV (oral polio vaccine) and one dose each of the measles vaccine and the BCG (Bacillus Calmette-Guerin) vaccine to infants.

According to informed sources, the only significant discussions at the meeting were on: (a) expanding the UIP to include the hepatitis B vaccine in all the States from the present 11 on the basis of a proposal to be made by GAVI and the introduction, within a year or two, of the DPT-hepatitis B combination vaccine; (b) the governments plan to introduce the pneumococcal vaccine into the UIP within a year; and (c) the phased introduction of a new-generation pentavalent vaccine (a combination vaccine of DPT, hepatitis B and Haemophilus influenzae type b, or Hib) on the basis of an approach paper that the Ministry of Health and Family Welfare (MoH&FW) is to prepare within three months.

Representatives of GAVI and its partners, the mission director of the National Rural Health Mission (NRHM), a Joint Secretary in the MoH&FW, the Drug Controller General of India (DCGI) and the UIP Assistant Commissioner of Immunisation participated in the meeting.

GAVI was launched in 2000 at the World Economic Forum in Davos. Among its partners are developing-country and donor-country governments, the World Health Organisation (WHO), the United Nations Childrens Fund (UNICEF), the World Bank, the vaccine industry in industrialised and developing countries, research and technical agencies, non-governmental organisations (NGOs), and the Bill & Melinda Gates Foundation. India, it is learnt, is eligible to receive $350 million from GAVI for new vaccine introduction, health system strengthening (HSS) and injection safety. An initial $40 million has apparently been used already for injection safety and hepatitis B vaccine introduction. It was towards evolving a proposal that would enable the utilisation of the remaining amount that the meeting had been called. The path envisaged for that is now clear: the introduction of Hib, pneumococcal and pentavalent vaccines.

This, many medical experts argue, is the manner in which priorities are identified in the national immunisation programmes in developing countries: driven by the exogenous push of external donor agencies and the associated money.

In an editorial in the January issue of Indian Journal of Medical Research (IJMR), Jacob M. Puliyel, a paediatrician at St. Stephens Hospital, New Delhi, and Yennapu Madhavi, a scientist at the National Institute for Science, Technology and Development Studies (NISTADS), New Delhi, write:

A slew of new vaccines has come to the market and numerous others are in the pipeline. Not all of these meet the actual needs of the majority. As a new product is being readied, research is published to highlight the number of deaths in the country caused due to the absence of that vaccine. The estimates are often outright exaggeration or reflect poor research design. Public-private partnerships disguise the role of the pharmaceutical company in such research. Pharmaceutical companies can drive the agenda but be hidden within agencies like GAVI. This role of international agencies and their nexus with multinational companies in influencing the public health priorities of developing countries has already received some critical analysis. The general principle that the one who pays the piper calls the tune applies to vaccine research as well.

Giving the example of the pulse plus polio immunisation, Puliyel points out how the programme in India began in 1995 with a grant of $20 million from the United States after the WHOs call for the eradication of polio by 2000. Soon afterwards, donor fatigue set in, he says, requiring the Indian government to borrow $180 million from the World Bank for the programme.

He points to World Health Assembly Resolution 45.17, which mandates that newer vaccines that are cost-effective be integrated into national immunisation programmes. However, funding agencies such as GAVI conveniently circumvent the issue of cost-effectiveness by providing grants. The cost thus comes to zero, and a country is persuaded to initiate the programme. After some time the funding is withdrawn but countries are forced to continue with the programme, and without resources, they resort to borrowing, says Puliyel.

Specifically on the vaccine for Hib, a bacterial illness that can cause a potentially fatal brain infection in young children, the editorial quotes from the WHO position paper of November 2006, which states: In view of the demonstrated efficacy and safety, conjugated Hib vaccine must be included in all routine infant immunisation programmes. Lack of local surveillance data should not delay the introduction of the vaccine (emphasis added).

Puliyel points out that in India surveillance data have always shown that there is no need for the vaccine. We have always cultured the bacteria from the throats of Indian children but we have never found it in meningococca [the thin membrane covering the brain and the spinal cord], says Puliyel.

According to him, under the WHO-sponsored Invasive Bacterial Infections Surveillance (IBIS) programme in India, a hospital-based study cultured the bacteria only in 125 cases over a few years and a community-based study found the prevalence rate to be nine in 100,000 only, but these results were not published. This figure is the same as we know for years. We in India seem to be protected against Hib because of E.coli in our bodies, which has the same bacterial envelope as Hib and hence there is strong cross-sensitivity. But the WHO says that we must use Hib in India based on Indonesian or African data. The Probe Study in Bangladesh on a larger number of cases has now been discontinued and strangely now the WHO wants surveillance for Hib disease to be carried out after the introduction of the vaccine, says Puliyel.

The paper of the WHO advocating universal vaccination with Hib, irrespective of an individual countrys disease burden, irrespective of natural immunity attained within the country against the disease, and not taking into account the rights of sovereign states to decide how to prioritise use of their limited resources, is an example of top-down approach of global organisations like the WHO, Puliyel and Madhavi write in their editorial.

Arguing against the unwarranted introduction of the so-called combination vaccines, or value-added cocktail vaccines, Puliyel and Madhavi say the tendency to combine primary vaccines with non-UIP vaccines will not only create artificial scarcity of the affordable primary vaccines but also offer scope for a back-door entry of expensive and perhaps unnecessary vaccines into the UIP.

In particular, Puliyel argues against the need for a hepatitis B vaccine in the Indian context. According to him, projections on Indian figures for liver carcinoma are vastly exaggerated because they are based on extrapolations from Taiwanese data, which Indian clinical data do not bear out. According to Puliyel and Madhavi, the inclusion of the DPT-hepatitis B combination vaccine raises the DPT immunisation cost 17-fold.

Writing from the perspective of cost-benefit analysis in the June 2006 issue of Current Science, Madhavi argues against the introduction of universal hepatitis B immunisation. She points out that despite falling prices of the recombinant hepatitis B vaccine, it costs over three times the total cost of all UIP vaccines. This, according to her, implies that the cost of universal hepatitis B vaccination equals the total budget allocated for health and family welfare and is six times the combined budget of national programmes against malaria, leprosy, acquired immune deficiency syndrome (AIDS) and tuberculosis.

Anant Phadke, a Pune-based public health activist who has also done a cost-benefit analysis of hepatitis B vaccination, agrees. I do not see why these combo vaccines should cost so much. Ultimately, the patient has to pay, even if technically one were to make a case for introducing such a vaccine, he says.

But there are medical experts who disagree and argue strongly for the introduction of such vaccines. If India was a poor economy, there would be merit in such arguments, says T. Jacob John, the well-known virologist from Christian Medical College (CMC), Vellore. We have money to buy fighter jets but we shy away from treating people. The affordability principle has to stop. Right now the vaccines may cost more. We do not have capable health economists to help the country make the correct choice. But I am convinced that the overall economics in the use of combination vaccines and other vaccines ultimately would be cheaper if it becomes part of the national immunisation programmes. Already many private players are keen on the pentavalent vaccine and would be ready to provide it if introduced at much lower costs, he says.

He also makes the following argument from a medical perspective. The primary reason for hepatitis B vaccination is not to prevent liver cancer; it is to prevent cirrhosis of the liver, the incidence of which is high. The economics must be based on cost per life saved and not on a cost-benefit analysis without having any data on disease burden, which in the Indian context we may never have. Similarly for Hib and pneumococcal vaccines. One must make a clear distinction between highly contagious diseases, which are universal and ubiquitous. All the children the world over are at equal risk to infection. The vaccines should be viewed from the perspective of the benefit of disease prevention. Disease is a poverty-inducing element, says Jacob John.

Of course, these must be introduced, says M.K. Bhan, Secretary, Department of Biotechnology (DBT). Primary vaccine should include all these. Indigenous Hib is ready, he adds.

The Union Ministry, of course, is all set to introduce these one by one despite the fact that in February 2006, in the context of meningitis vaccination, it ran a huge advertisement in newspapers saying that there was no need to get vaccinated against meningitis and warned against commercial claims being made with regard to various types of vaccines that went beyond the UIP.

Hep B has been introduced in the national programmes of 120 countries, Hib in 50 countries and pentavalent in 105 countries. So why not India? asks the Union Minister for Health Anbumani Ramadoss. Why should a child be injected nine times within the first nine months if the same can be done with three using a DPT-Hep B combo vaccine? Panacea Biotech is already developing the pentavalent vaccine, which will provide prevention against Hib as well, says Ramadoss.

At a GAVI partners meeting last December in New Delhi, marking the launch of phase-II of the alliance to cover more children, Prime Minister Manmohan Singh said India, with some of the largest vaccine manufacturers of the world, could become a hub for vaccine production and play a leadership role in generating low-cost, effective, easy-to-deliver vaccines. Ramadoss, in his address at the meeting, hoped that with the creation of the new vaccine fund, GAVI would provide further financial support to extend immunisation coverage in the country.

Clearly, the move to disband production in the public sector units, which produced life-saving primary vaccines at the WHOs behest and to promote enterprises in the private or in the public-private partnership mode, is an indication of moving down the road laid by external agencies such as GAVI, whose emphasis is on the introduction of newer vaccines, which can create a huge market in India for the multinationals developing them.

The question is not whether we need these newfangled vaccines; the question is whether they should be at the cost of universal coverage with primary vaccines under the UIP?