Vaccine Eloquent

Universal vaccination became part of government policy in 1978. A quarter of a century since, progress has been fitful. In some parts of the country -- the south especially -- progress has been impressive, but in two of the most populous states -- Bihar and Uttar Pradesh -- very little headway has been made. As of now, just about half the children in the country are vaccinated against the six most common diseases -- diphtheria, measles, whooping cough, polio, tetanus and tuberculosis -- that are included in the government's universal immunisation programme (uip). Currently, the annual budget for the programme is Rs 2,221 crore approximately. Global agencies are supposed to help developing countries meet their targets as well as the un's millennium development goal, which is to reduce under-five mortality by two-thirds by 2015. This target will be deemed to have been met if two-thirds of children under one are vaccinated against measles by that date. But on the ground, the role of global agencies is actually making the task of meeting targets even more difficult, by insidiously changing programme priorities in the developing world. Hepatitis b is a case in point. The Global Alliance for Vaccines and Immunisation (gavi) nudged India towards including the disease in the uip. It funded a pilot project after which the Indian government included hepatitis b in the universal programme. The unfortunate part of the story is that gavi just funded the pilot project and the government is now saddled with an expensive vaccine in its programme. This is changing the design of the country's vaccination programme. Traditionally, India, and other developing countries, have spent more on their delivery systems than vaccines themselves, because that is needed for deeper penetration levels. This has been possible because vaccines for the six uip diseases are cheap. But as expensive vaccines are coming into play, more money is being spent on vaccines and the delivery system could suffer. Vibha varshney reports on India's vaccination regime, its global context and the new technologies that are emerging from Western laboratories.

 
By Vibha Varshney
Last Updated: Sunday 07 June 2015

Vaccine Eloquent

 SPACED OUT

South stuck between rock and hard place


imageAgood example of how manouevring space for developing countries is being constrained is the case of the vaccine for measles, mumps and rubella (MMR). A generation ago, in Delhi you could get vaccinated only for measles and the vaccine was cheap. Now, under the routine immunisation programme in Delhi every child has to get the combined vaccine for MMR, which is double the price, at a conservative estimate. Either government shells out or the consumer.

This is not an isolated example. Worldwide programmes are being expanded to include combination vaccines or new ones, increasing per capita expenditure on immunisation. GAVI, which consists of governments of developed and developing countries, UN agencies, multilateral bodies and the pharmaceuticals industry (see box: Alliance board), plays an important role in restructuring national programmes.

Seventy-two countries, with a per capita income less than us $1,000, are eligible for gavi support. Till now, gavi has delivered underused vaccines, usually expensive vaccines for which supply far outstrips demand, to 27 countries and transferred funds to support immunisation in 24. But its expenditure statistics show clearly the direction in which it is pushing. The projected figures for 2005 show that gavi spent us $109 million on new vaccines and us $27 million on auto-disable syringes, while it spent only us $48 million -- roughly 26 per cent -- on support for immunisation services. In sharp contrast, India spent 48 per cent of its budget on training and 14 per cent on service delivery (see table Gavi shuffle; and chart Vaccination cake). The implication is clear gavi is not spending much on helping developing countries increase levels of vaccination penetration, though it is spending on acquiring vaccines. One of gavi's criteria for support shows what its priorities are. It makes just 50 per cent coverage of diphtheria, tetanus and pertussis (dtp) -- the third dose of the old dtp vaccine -- a prerequisite for extending support for new vaccines .

gavi
stocks

With expensive, new vaccines making their way into national immunisation programmes spending on vaccines is bound to increase. Consider the following. The price for a combined mmr dose can be as high as us $28 in the us , while unicef buys a single dose of the traditional measles vaccine for 10 cents. Again, the traditional vaccine against dtp used in the developing world costs unicef just 7 cents per dose, as against new dtp vaccines used in the developed world, which costs us $10.65.

Hepatitis B and Haemophilus influenzae type B (Hib) are also cases in point. The hepatitis B vaccine is now part of the immunisation programmes of 153 countries — up from 12 in 1990. In India, the introduction of the vaccine was based on miscalculations. The number of deaths from hepatitis B was exaggerated — up from 5,000 to 250,000 per year. These figures were later successfully contested (see box: Model mayhem).

The Hib vaccine is next on GAVI’s agenda. At its Delhi meeting, the Hib initiative was launched to counsel developing countries about the need for the vaccine. So far, 92 countries have introduced the Hib vaccine but it is likely to be the eighth vaccine to be included in the World Health Organization’s (WHO’s) Expanded Programme on Immunization (EPI). This initiative uses the example of its success in The Gambia, where meningitis and severe pneumonia in young children have virtually been eliminated through Hib vaccination.

GAVI is pushing the vaccine in India though the evidence to show it does not need to be part of a universal programme is strong. A 2002 study, found just 125 Hib cases among 5,798 cultures — that works out to 2.1 per cent. Not convinced, WHO undertook a study, which found the incidence of Hib at nine per 100,000. WHO hasn’t published the findings yet, though the British journal Expert Review: Pharmacoeconomics and Outcome Resesarch reported that they were presented at a conference. GAVI has now funded another study — to the tune of us $9 million — to be carried out by the Indian Council for Medical Resesarch (ICMR) in Kolkata, Chandigarh and Chennai. Results are expected in six months.

This shift has strengthened an insidious shift in vaccine production and availability. Availability of basic vaccines had improved between 1992 and 1997 with manufacturers from developing countries manufacturing them. But this gain was offset when firms in the developed world started discontinuing such vaccines, especially those used by UNICEF for EPI (see graph: Falling stocks). Given that worldwide vaccines form less than 2 per cent of the pharmaceutical industry, there is no incentive to make basic vaccines when new vaccines fetch better prices. When developed countries began to use the new vaccines, it was a nail in the coffin for their poorer cousins.

EPI programmes are, therefore, getting more dependent on a handful of manufacturers from developing countries which still manufacture basic vaccines because dollar payments, leading to tax breaks, still make it profitable. But they too increasingly want to move over to the highend business unless they get further incentives for EPI vaccines, as S S Jadhav, executive director, quality assurance and regulatory affairs, Serum Institute of India Limited (SSI), Pune makes clear.

At the macro-level, this trend might have deleterious consequences for universal immunisation. Immunisation is below 30 per cent in several parts of the developing world. WHO launched EPI in 1974 to ensure that every child gets vaccines against the six common diseases. By 2000, it succeeded in increasing coverage rates from just 5 per cent to 76 per cent. But far more has to be done. A recent study by WHO and UNICEF of in the GAVI-affiliated countries showed that 10 million additional lives could be saved per year by investing an annual average of US $1 billion on child and maternal immunisation between 2006 and 20015. The price tag for universal immunisation in the same period is US $35 billion, of which there is a US $10-15 billion shortfall.

But even increased funding may not be able to keep up with the shifting terrains of the markets unless policy changes, as we have seen. Take GAVI. It is estimated that one-third of its annual $35-billion budget for immmunisation will be spent on vaccines alone. But the annual spending on vaccines will rise from about $350 million in 2005 to nearly $1.5 billion in 2015, if programmes include underused and new vaccines. This is the crux of the problem.

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