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Immunization Focus A quarterly publication of the Global Alliance for and www.VaccineAlliance.org GAVI NEWS GAVI is a partnership of public and A for Africa private organizations dedicated to AF R I C A ’S much-feared epidemics though actual numbers were increasing children’s access of meningitis could be consigned probably higher. In the past year worldwide to immunization against to history within a decade with the alone, some 4000 died, and killer diseases. help of an ambitious project that thousands more were left with aims to develop and introduce permanent disabilities. Partners represented on the GAVI more effective vaccines tailored to Of five strains, or serotypes, of Board: the needs of the continent. meningococcal meningitis found The Bill and Melinda Gates The leaders of the project, the worldwide, serotypes A and C are Children’s Vaccine Program at World Health Organization and the the two most likely to cause PATH Program for Ap p r o p r i a t e epidemics. An A/C polysaccharide The Bill & Melinda Gates Technology in Health (PATH) are vaccine exists, but it does not Foundation in discussion with vaccine prevent the spread of National Governments manufacturers now and hope to between carriers and so cannot start field trials of candidate protect whole populations, nor Research and Technical Health vaccines between 2003 and 2006. does it protect infants, the most Institutes The partnership has been given vulnerable age group. Also, its The financial muscle with a grant of protection may be shortlived. As a Swathe of The United Nations Children’s US$70 million from the Bill & result, mass campaigns destruction: Fund (UNICEF) Africa’s meningitis Melinda Gates Foundation, must be organized every time an belt The Vaccine Industry announced on 30 May. epidemic occurs. Th e The If the project succeeds, it could Meningitis Vac c i n e The World Health Organization be a template for the development Project aims to and introduction of vaccines develop A/ C against other diseases that co n j u g a t e Immunization Focus primarily affect the world’s poorest vaccines which peoples. As well as bringing would protect Immunization Focus is issued candidate meningitis vaccines out in f a n t s , quarterly on the GAVI website at of the laboratory and through field provide lasting www.VaccineAlliance.org trials, the partnership aims to immunity and It is intended to provide updates overcome problems of licensing interrupt the spread of and topical debate about key products, financing their purchase infection. The technology for immunization issues at national and through global mechanisms, and making these vaccines has international level. It can also be ensuring an adequate supply to been available for a decade, meet needs. “I hope this project and conjugate vaccines are sent to you by email. could become a model for other licensed against other serotypes To receive a free email copy, vaccines for developing countries,” found in industrialized please send an email message to says Luis Jodar at WH O . countries. In contrast, [email protected] , with Meningococcal meningitis manufacturers had no incentive to « subscribe » in the first line of attacks a swathe of 18 countries make a vaccine against serotype A, your message. If you do not have across Africa (see Map), with which is restricted mainly to web access, paper copies of irregular and unpredictable Africa. The returns on investment Immunization Focus, downloaded epidemics that wreak havoc on were perceived as too low. and printed from the web, can be fragile health systems. The disease Of ficials from health ministries in obtained from your national is feared more than HIV or at least eight African countries told UNICEF or WHO office. , even though it kills fewer WHO what they needed in a Letters to the editor are welcome: people. In the worst recent season, vaccine. “This is a tailor-m a d e in 1996, about 200,000 cases and vaccine for Africa, designed by please write via the 20,000 deaths were reported, Africans,” says Dr Jodar. ■ GAVI Secretariat, c/o UNICEF, Inside this issue Palais des Nations, 1211 10, Global market – global vaccines? Supply and pricing of vaccines for developing countries 2 , Taking care of tomorrow: planning sustainable finance for immunization 5 or Gavi@.org Good management means good measurement: the Data Quality Audit explained 9 New resources for immunization professionals 10 GAVI Immunization Focus • June 2001 • Page 1 of 10 Immunization Focus UPDATE Global market – global vaccines? Vaccines for developing and industrialized regions have been diverging, but today’s global market is changing rapidly. Phyllida Brown asks manufacturers and others what the future holds

IT ha s n ’ t happened overnight, but gradually over a ● vaccine is usually combined with mumps decade. Vaccines for certain diseases now come in and , instead of being given alone; and di f ferent versions: those bought mostly by the ● Vaccines are packaged as single doses, without industrialized countries, and those bought mostly for preservative, whereas in developing countries the use in developing countries. norm remains multidose vials and some contain the There are several reasons for the split, including preservative . di f ferent patterns of disease and judgments of need. No w , a team from WHO, the World Bank and the But one key factor is the industrialized countries’ company Aventis Pasteur have investigated whether increasing desire to avoid any adverse effe c t s – this trend towards two separate “tracks” is affe c t i n g however small or uncommon – from vaccines against the supply or price of vaccines needed for developing diseases which are now relatively rare. In contrast, and industrialized countries(1 ) . The answer is that, for most developing countries where these diseases while today’s picture is still uncertain, current trends are still widespread, the benefits of the traditional could lead to supply difficulties and higher prices in vaccines still heavily outweigh their risks, while the the forseeable future. Supplies of some traditional newer vaccines are currently too expensive to be a vaccines, once well in excess of demand, have now practical option. fallen to the point where they only narrowly exceed Among the changes in industrialized countries, for demand (see Box 1). “A batch failure now could ex a m p l e : precipitate a shortage,” says Julie Milstien at WH O , ● Acellular pertussis (aP) has largely replaced one of the study’s authors. And, in some cases, prices whole-cell pertussis (wP) in the traditional “triple” that had remained stable for years are creeping up. vaccine for , and pertussis (DTP); But what is less obvious – and more important in ● Inactivated vaccine has largely replaced the the long term – is how far these trends will continue, oral vaccine; or whether different patterns will emerge. ◗

1: Endangered species: how and why supplies have been falling For years, the availability of trad i t i o n a l in 30 years, the competition for cap a c i t y is tetanus for use as components of vaccines supplied to UNIC EF for the in c r e a s i n g . the new conjugate vaccines. Expanded Programme on Immunization This situation particularly affects vaccines Some manufacturers in North America exceeded demand, usually by many millions with extremely low profit margins, such as have actually stopped making products such of doses. But in the past three or four years, BCG and meningitis A/C polysaccharide. For as DTwP . But European-based supplies of some vaccines have declined so example, Glaxo SmithKline (GSK) has said manufacturers have traditionally served a that they only narrowly exceed demand. that it cannot commit itself to producing as more global market and say they will These include BCG, DTwP, tetanus much meningitis A/C vaccine for next year continue to do so. For example, says Michel and measles (see Figure 1). For example, in as it did for this year, partly because its Greco of Aventis Pasteur in , 70% of 1998, UNIC EF was offered 600 million doses fr e e z e - d r ying cap a c i t y has been allocated to the vaccine doses made by the company of DTwP . In 2000, the agency received a the manufacture of . “It’s true are destined for developing countries, response to their tender of just 150 million that both [vaccines] need to be freeze-dried although these represent a fraction of doses. Prices of these vaccines have and you have to allocate cap a c i t y,” says ov e r all revenue. Whole-cell DTP, for remained static for long periods but several , Tony Lakavage at GSK. He adds, howe v e r , example, will continue to be made, not least including measles and DTwP, appear to be that ensuring a match between demand be c ause the supply of acellular pertussis is rising slightly now(1, 2 ) . and supply is always difficult with meningitis likely to be limited. “You can manufacture Part of the reason for the fall in supplies is A/C vaccine, because epidemics are 10 doses of whole-cell pertussis for every 1 that the traditional vaccines, typ i c ally priced irregular and unpredictable. dose of acellular pertussis in the same at a few cents per dose for UNIC EF, fail to The low prices offered by producers in fa c i l i t y,” says Mr Greco. compete with newer vaccines such as developing countries have also reduced the Indeed, in Mr Greco’s view, there is no type b(Hib), whose incentive for manufacturers in high-income reason why developing countries should not profit margins are much higher, for countries to make traditional products, says continue to use different products from manufacturers’ limited capacities for Walter Vandersmissen at GSK, citing their industrialized counterparts, provided production, filling and packaging. “We buy “gigantic offers from [suppliers in] qu a l i t y is assured. “Even if philosophical l y the ‘penny’ vaccines and compete for filling- developing countries to UNIC EF” as one the dual-track concept is not a pleasant one, line space with multidollar vaccines,” André reason for the fall in DTwP supplies from in practice it may be preferable,” he argues, Roberfroid of UNIC EF told delegates at last the industrialized countries. However, there given that many countries cannot afford the year’s GAVI Partner’s Meeting in Noordwijk, are other technical reasons for the reduced higher-priced vaccines. Products should be the (2 ) . And, as the number of av a i l a b i l i t y of DTwP, he says, including chosen case by case, he says, based on a routine children’s vaccines available in changes in production methods and the co u n t r y’s disease burden, its resources, and industrialized countries has roughly doubled increased demand for both diphtheria and the vaccine’s efficac y and safety.

GAVI Immunization Focus • June 2001 • Page 2 of 10 Immunization Focus UPDATE

Figure 1: Availability of three “traditional” vaccines supplied to UNICEF DTwP BCG Measles 600 400 400 Availability Availability 350 Availability 500 350 Demand Demand Demand 300 400 300 250 250 300 200 200 200 150 150 100 100 100 50 50 0 0 0 1997 1998 1999 2000 2001 2002 2003 1997 1998 1999 2000 2001 2002 2003 1997 1998 1999 2000 2001 2002 2003

Year Year Year Source: (1)

The global vaccine market is evolving rapidly for at DTw P – an order of magnitude less costly than DTaP . least two reasons: first, the rise of new entrants into In , says Isaias Raw, president of the Sao-Paulo the market, in the form of manufacturers in based producer Instituto Butantan, “Adopting aP developing countries whose products are increasingly would represent going from cents to many dollars important for global supply; and second, new buying [per dose], and would result in a decrease in power and mechanisms, through GAVI and the Fund, vaccination.” for the low-income countries. These changes are also But it would be a serious misjudgment to think that happening against a background in which the the developing-country manufacturers are restricting requirements of regulatory bodies are becoming themselves to the “old” vaccines. Some, such as increasingly stringent. So in some respects, today’s Bharat Biotech and Shantha Biotechnics, both of “d i v e r gence” of products along two tracks for Hyderabad, , are already developing developing and industrialized countries reflects the combination vaccines such as DTP-HepB, for which conditions of the past decade, and events over the the emergence of GAVI and the Fund has sharply next five years may be different. “This marketplace increased demand. In some cases, says Susan has changed dramatically,” says Tony Lakavage, McKinney at WHO, combinations are being senior director of external affairs at Glaxo achieved by different developing-country producers SmithKline in Rixensart, Belgium. collaborating and “marrying” components. “This marketplace First to agree would be the manufacturers “These producers are on a fairly fast track in developing countries, who were once has changed to providing a DTP-HepB combination,” labelled as “local” producers but who now dramatically” says Ms McKinney. play a much bigger role. “Manufacturers such as Bio Another mistake would be to assume that the Farma have actually changed the global supply developing-country producers will make products picture radically,” says Thamrin Poeloengan, only for developing countries. As well as these, says president director of this Indonesian supplier to Krishna Ella of Bharat Biotech, “We also see UN I C E F , based in Bandung. ourselves as contract manufacturers for vaccines and Immunization Focus sought the views of a range of other biologicals for the industrialized countries.” producers in developing countries on the direction Indeed, a few manufacturers in developing countries that vaccine production is taking. Their responses are considering developing vaccines that may appeal demonstrate that they are all highly committed to to industrialized and developing countries equally – meeting the health needs of developing countries, such as meningitis conjugates or . with vaccines against diseases that primarily affe c t Eq u a l l y , it would be simplistic to assume that poorer populations. However, the actual products developing countries will never want the products they make to meet these needs may change fast. An d that have replaced traditional vaccines in most of the the prices they charge may change too. Some of the industrialized countries. Varaprasad Reddy, managing developing-country vaccine producers, particularly director of Shantha, is just one of the producers who those who are public-sector institutions, insist that believes that populations in at least some emergi n g they will be able to continue making vaccines at and middle-income countries will gradually shift to d a y ’ s very low prices, taking advantage of their demand as income increases and disease burden economies of scale. But others say that their prices changes. Dr Ella at Bharat Biotech agrees. may have to rise. In the short term, however, a more pressing issue Until now, most developing-country producers have issue is whether the developing-country producers’ concentrated on making traditional vaccines such as prices will rise. Tra d i t i o n a l l y , these manufacturers DTw P and measles and also, recently, monovalent have offered their products to UNICEF at very low vaccine. For most low-income countries, prices – even lower than the concessionary prices the high prevalence of childhood disease and a lack ch a r ged on sales to UNICEF by the industrialized- of resources make the traditional vaccines the most country manufacturers. But this situation may not be appropriate response, they argue. Take, for example, sustainable. As developing-country manufacturers ◗

GAVI Immunization Focus • June 2001 • Page 3 of 10 Immunization Focus UPDATE

improve their production facilities to meet the 2: Not every industrialized country wants to ditch the increasingly stringent regulatory requirements for “old” vaccines international sales, their production costs are rising. For David Salisbury, head of the immunization and infectious Whoever makes the traditional vaccines, it seems that diseases group in the UK government’s Department of Health, they cannot remain as cheap as they have been. the falling supply of certain “traditional” vaccines is a major Modern vaccine production requires massive capital problem. In his view, it has become a seller’s market. “We investment, but once the plant is up and running the find it difficult because you cannot say to a manufacturer, number of personnel needed is small. So the savings ‘This is which vaccine we want’ – and we are the customer.” on labour costs that can be made in developing In the UK, children are still immunized with DTwP becau s e , countries by other industries, such as clothing or Dr Salisbury says, trials have shown that the whole-cell software production, do not apply to vaccine vaccine protected 85% to 90% of children, whereas acellular producers. Producers that have traditionally charge d products’ efficac y ranged from 70% to 85%. Despite other vaccine safety “scares” , British parents today generally find very low prices may have to raise them if they are DTwP acceptable, says Dr Salisbury, and immunization rat e s going to invest in modernizing equipment. with the vaccine remain high. “Why would we change to a Companies in the industrialized countries, less efficacious vaccine at higher cost?” he asks. Yet, becau s e meanwhile, have historically been prepared to sell of supply problems with whole-cell vaccine, Britain recently vaccines for use in developing countries at reduced had to use the acellular product for a period. prices because they make more money on sales of British children are also given oral when many the same products in the industrialized countries. other industrialized countries have shifted to inactivated But, obviously, if few in the industrialized countries vaccine to avoid the risk of vaccine-associated outbreaks. The want to buy these same products, the options for co u n t r y’s historical links with the Indian subcontinent and of fering them at these “tiered” prices in the some West African states, where polio remains endemic, developing-country markets may diminish. For mean that there is constant and large-scale traffic betwe e n Britain and these regions, and this raises the risks of wild-typ e David Salisbury, head of the immunization and virus entering the country. “We constantly review and review infectious diseases group in the UK government’s this policy,” says Dr Salisbury. When polio transmission stops Department of Health (see Box 2), this is a major in these regions, the balance of risk and benefit will change, problem for the world as a whole. It is implausible, and the switch to IPV will be made, says Dr Salisbury. he believes, that the major manufacturers will products and continued investment in R&D. And that continue to offer vaccines at reduced prices for means keeping the incentives for both to stay. Expensive kit: developing countries if they can no longer get the In the medium term, the emergence of GAVI and vaccine production higher prices they need from the industrialized the Fund may be improving the incentives to is capital-intensive country markets to make their products profitable. manufacturers – at least for some vaccines. Co m p a n i e s ’ decisions about whether or not to develop products for developing countries are based, says Lakavage at GSK, on “an assessment of what the purchasing entities can and will buy”. With GAVI and the Fund catalysing changes in the market, he says, “there are more resources for purchase, and improvements in the infrastructure to deliver the vaccines”. Demand for vaccines is also becoming easier to foresee with work done by the GAVI Financing Task Force’s subgroups on forecasting and procurement, together with the new purchasing arrangements that UNICEF is now adopting for new and under-used vaccines paid for by the Fund. And in the longer term, as tougher regulatory demands drive Companies such as Aventis Pasteur and GSK have costs up, both producers and buyers in a global said they will keep tiered pricing – for now. “We are market will need to be willing to invest more in committed to tiered pricing as long as we have products whose value the world has taken too much protected pricing in Europe and the ,” for granted. The next few years will be critical. ■ says Lakavage. “That is our stated public position. But what happens in the developed world does have Re f e r e n c e s : an impact on what happens in the developing world.” (1) Divergence of products for public sector immunization In circumstances as uncertain as today’s market, pr o g r ammes. Milstien, Julie, S. Glass, A. Batson, M. Greco and J. then, what can anyone do to ensure that high-quality, Be r g e r . Presentation to the Strategic Advisory Group of Experts of appropriately priced vaccines keep flowing to meet WHO’s Department of Vaccines and Biologicals, Montreux, 15 June the needs of developing countries? In the end, says 200 1. www.Va c c i n e A l l i a n c e . o r g / r e f e r e n c e / p p t / s a g e 1 36. p p t Dr Milstien at WHO, it’s vital that manufacturers (2) Roberfroid, A. presentation to the GAVI Partners’ Meeting, from both the industrialized and the developing Noordwijk, the Netherlands, November 2000 countries stay in the market to assure a range of ww w. Va c c i n e A l l i a n c e . o r g / r e f e r e n c e / p p t / r o b e r f r o i d . p p t

GAVI Immunization Focus • June 2001 • Page 4 of 10 Immunization Focus SPECIAL FEATURE Taking care of tomorrow Developing countries – and other GAVI partners – are starting to plan how immunization services should be financed beyond 2005. Along the way, they may even be triggering a rethink of the relationships between countries and donors, as Phyllida Brown reports NO T so long ago, Zimbabwe’s done seven years ago. 1: Steps to sustainability: how immunization programme Paulinus Sikosana, Secretary for countries are preparing plans experienced some of the worst Health and Child Welfare in Next year, the first countries will be ef fects of an unsustainable Zi m b a b w e ’ s health ministry, told asked to submit plans to GAVI showing financing scheme. Through a the GAVI partners this cautionary how they will phase in money from financial loophole in the then- tale earlier this month at a other sources and how they will closed economy, international meeting in Geneva(1 ) in which sustain their programmes after their corporations in Zimbabwe could developing countries started to five-year awards end. This month’s donate money to a non- plan how they should pay for their meeting was one of the first steps in governmental organization, which immunization programmes from preparing for those plans. The GAVI increased the proportion of their 2005 onwards (see Box 1). Financing Task Force (FTF) and others worked with teams from four countries profits that they could repatriate. Although the circumstances of the For its part, the organization used – Bangladesh, Benin, Ukraine and incident are clearly different from Zimbabwe – to seek their views about the donations to buy hepatitis B the way GAVI works, the message what a sustainability plan should vaccine for introduction into the was clear: once immunization contain, and how sustainability should national immunization starts, it must be sustained. be measured. Unusually for a health programme. Vaccination began, Governments must take meeting, officials from the finance but, soon after, the law changed responsibility for ensuring their ministries of several of the countries and the scheme finished. Vac c i n e immunization programmes are participated. Using the four teams’ supplies stopped, babies could no stable, but donors and other input, the FTF will report to the GAVI longer be immunized against the partners must also act responsibly. Board and then develop guidelines by virus, and many parents No one should be more aware of this winter for all countries to use in mistakenly assumed there was this responsibility than GAVI and preparing their plans. Some of the Paulinus Sikosana: countries’ suggestions for the content education and something wrong with the vaccine the Fund. Their awards to of a sustainability plan are shown in long-term planning itself. countries are intended as catalysts. Box 4. are essential That was in 1994. Since 1999, The awards last for five years, and Zimbabwe has successfully re- the money can be spread over following on in the longer term,” introduced hepatitis B seven if a country chooses. But says Steve Landry, from the US vaccination as part of a when the awards run out, Agency for International properly planned, countries will need diffe r e n t , Development (USAID) and co- go v e r n m e n t - f u n d e d sustainable sources of funds. If chair of the GAVI Financing Tas k programme – helped by the GAVI partners – the countries Force. a major education themselves, plus donors, campaign. But no one development banks and the A widening gulf un d e r- e s t i m a t e s international agencies – do not Some developing countries are the damage plan sustainable financing for increasing their investment in the second half of this decade and health despite difficult economic beyond, those countries will be no conditions and severely limited better off – and possibly worse off resources (see Box 2). – than before the awards were Immunization remains one of the made. “If we fail, we will create a most cost-effective health vacuum, by starting things and not interventions, and accounts for no more than 5% of the health Figure 1: Closing the gap: the costs of running Côte d’Ivoire’s immunization programme budget in those countries studied so far, and often much less. As a $10,000,000 Cost of Programme with percentage of those countries’ $8,000,000 Improvements gross national product, Cost of Existing $6,000,000 Programme immunization accounts for no (2 ) Current Funding more than 0.1% . But the costs – $4,000,000 as well as the benefits – of $2,000,000 immunization must be expected to grow as under-used vaccines and 2000 2001 2002 2003 Source: (2) essential improvements, such as ◗

GAVI Immunization Focus • June 2001 • Page 5 of 10 Immunization Focus SPECIAL FEATURE

higher coverage, a better cold themselves in the foreseeable Levine, a health economist at the chain and the introduction of auto- future looks increasingly World Bank, and others, call for a disable syringes, are built into unrealistic. Indeed, the experience new definition of financial national programmes. The gap of the 1990s had already shown, sustainability for developing between what many governments says Tore Godal, executive co u n t r i e s ’ i i m m u n i z a t i o n pay for immunization now and secretary of GAVI, that some programmes. No longer, they what they will need to pay is large programmes from which donor ar gue, need sustainability be – and growing. support was withdrawn were not considered to be synonymous In Côte d’Ivoire, for example, a sustained. Despite this, some with self-suffi c i e n c y . In current recent study suggested that, by donors and analysts have conditions, after all, progress 2003, improvements to the continued to argue the philosophy towards self-sufficiency would existing national programme and that developing countries should mean, in effect, a growing “health the addition of move swiftly to achieve self- gap” between rich and poor would more than double the su f ficiency because dependency nations. At this month’s GAVI annual cost of the programme, on donors is undesirable. meeting in Geneva, the from under US $4 million to In the near term, sustai n a b i l i t y participants discussed and about $9 million(2 ) (see Figure 1). need not mean self-sufficiency endorsed the ideas put forward by Given the many competing No w , however, fresh thinking Dr Levine and her colleagues. Th e demands on the health purse, the has produced proposals for a more participants proposed that: idea that cash-strapped realistic way forward. In an “Although self sufficiency is the governments in the poorest an a l y s i s (3 ) commissioned by the ultimate goal, in the nearer term countries will be able to finance GA VI Financing Task Force, Ruth sustainable financing is the ability such services entirely by of a country to mobilize and ◗

2: A tale of two countries Siddiqur Choudhury Benin: political commitment and prac t i c al schemes to can raise and what it needs. “We gu a r antee funds must be realistic,” he says. “With Jacques Hassan, director of research and development in the best will in the world, the Benin’s health ministry, is hopeful. Although income per head is government cannot do everyth i n g just $325 a year, the country’s immunization budget has alone. We need help from increased by an amount exceptional for any country – almost 30- external contributors and from the fold – since 1996. Back in 1982, just 12% of children were private sector.” routinely immunized; today, the reported figure is 85% and Bangladesh: popular demand Benin has received an international award for its program m e ’ s for immunization will ensure success. Immunization has high-level political support; the the future of the servi c e president immunizes children himself on polio days. Equally important, the health budget contains a line item for For the government of immunization so that the programme is always allocated a Bangladesh, there’s no question minimum sum. that immunization must be assured for the long term, says But there are acute strains. Many health threats compete for Siddiqur Rahman Choudhury, a senior official in Bangladesh’s resources. As in other developing countries, trained personnel finance ministry who attended the Geneva meeting. A key step, are scarce and the international brain drain keeps taking them he says, is to educate and inform people, and especially girls, so aw a y . Staff are overstretched, and there is a risk that coverag e that demand for immunization grows and remains high. Mothers will fall. Benin has applied to GAVI and the Fund for awards to who have received education are more likely to protect their introduce additional vaccines and to improve its existing servi c e s . infants’ health than those who are uneducated. “Once you Already, the government has taken steps to mobilize new and popularize immunization, the government cannot stop providing sustainable resources at home. It has set up an EPI Fou n d a t i o n , it,” he says. “That’s the way to build financial sustainability.” to collect private donations and Bangladesh’s overall health budget has increased from 4.7% of use them to help purchase the total government budget in the mid-1980s to 7.5% of the vaccines. It is also developing total today. Within the immunization programme, a World Bank health insurance schemes that loan pays much of the cost of vaccines, and only 22% of the will give people incentives to pr o g r amme is currently funded by the government’s own direct prevent ill health in their families, resources. Before applying to GAVI and the Fund for support, and creating income within Bangladesh committed itself to sustaining the programme after communities to pay for some the awards run out. “We will have to, not because GAVI has costs of the immunization asked for it, but because there is a need for it, a demand for it,” pr o g r amme, such as fuel and says Mr Choudhury. “A good programme is useless unless we vehicle maintenance. sustain it.” And, because that cannot be done by Bangladesh Nonetheless, Dr Hassan is under alone at present, it is up to the government, donors and lenders no illusions about the gap to work together, he says. “Sustainability should be a joint be t ween what the government re s p o n s i b i l i t y of national governments and donors.” Jacques Hassan

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ef ficiently use domestic and estimates of the cost-effe c t i v e n e s s Practical ways to move supplementary external resources of vaccines – to argue its case towards sustainable financing on a reliable basis to achieve with external and private domestic ta r get levels of immunization investors. “The challenge is For governments: performance*.” fundamentally a political one,” Use existing resources more This definition emphasizes a says Dr Levine. For, despite the efficiently go v e r n m e n t ’ s skills in planning growing costs of wider ● Identify main inefficiencies, and securing stable funding for immunization, the absolute including wastage, and correct immunization, and making good amounts of money involved are ● Reduce barriers to children’s use of its resources, rather than its small relative to other health access to immunization through new ability to pay for everything itself. interventions. “The resources are approaches to service delivery Under this definition, the spectre there,” says Dr Levine, “both in ● Educate people to increase of “donor dependency” becomes countries and in the international demand for immunization, and keep less threatening, because the co m m u n i t y . Compared with many demand high national government is taking other health interventions, argu i n g ● Buy vaccines efficiently (through re s p o n s i b i l i t y , and negotiating the case for immunization is really international or national with its partners on what it needs easy – even when you add the mechanisms) to achieve its goals. new vaccines such as hepatitis B Mobilize resources The definition also means that a and Hib this is not actually a lot of ● Get a mandate for baseline government is responsible for mo n e y .” Dr Levine points to funding such as using its resources as efficiently as countries such as Honduras, and ● a budget line item (this is possible, while at the same time Bolivia (Box 3), whose political already in place in many countries) meeting standards for quality and commitment to immunization can ● a law to protect a minimum sa f e t y , and reaching increasing only be envied by most budget for immunization (Ukraine, numbers of hard-to-reach industrialized countries. for example, has this) children. Programme costs can be Ne w thinking for donors, too ● a memorandum of kept in check, for example, by understanding between the The new definition also using the best value vaccines and government and the Interagency challenges donors to update their the most cost-effective means to Coordinating Committee (Bolivia, for roles. In a global economy, the immunize children. For the new example, has this). benefits of immunization cross approach to sustainability to work, ● Push for the allocation of borders. So, out of self-interest as it ’ s essential that the government resources to immunization on the well as a concern for people’s should have a strong commitment grounds that it is cost-effective and welfare, it makes sense for richer to immunization, and evidence at benefits society at large, not just countries to invest in the health of its fingertips – individuals Ruth Levine: poorer ones. Evidence is such as ● Commission and disseminate “The challenge is mounting that better health is a cost-effectiveness studies fundamentally a key step to reducing poverty in ● political one” Earmark funds and establish the poorest economies. To ensure performance targets for regions sustainable support, donors could ● Engage development partners in be asked to commit themselves in an informed discussion of resource writing to a certain number of needs, and seek structured years. If there is to be a genuine commitments to fill key funding gaps collaboration, donors who are used to setting targets for the For donors/development partners: countries they support could even agree to meet certain targe t s ● Engage in a collaborative way, as themselves so that responsibility true partners in a shared challenge is evenly shared. ● Within the health sector, promote But definitions are just the use of resources for cost-effective interventions such as immunization definitions. What difference will a ● new definition make? Potentially, Move towards multi-year commitments a lot. After delegates at the ● Geneva meeting supported the Structure grants and loans to promote sustainability (for example, broader definition of using performance-based criteria) su s t a i n a b i l i t y , it is now being ● Consider developing new funding put to the GAVI instruments that are buffered from Board. If GAVI the impact of the donor countries’ policy is built domestic political changes. round the new definition, it could give ◗ Source: adapted from Levine et al(3) GAVI Immunization Focus • June 2001 • Page 7 of 10 Immunization Focus SPECIAL FEATURE

3: Sweet victory: how Bolivia put performance into its programme Vaccine Program at PATH . (2) Kaddar, Miloud, Ann Levin, Lea n n e In 1999, faced with falling vaccination coverage, Bolivia set about revamping its immunization programme, with the World Bank and the Pan American Health Do u g h e r t y and Daniel Maceira. May 200 0 . Organization as partners and co-financers of the initiative. As well as improving the Costs and Financing of Immunization service by adding new antigens, implementing safe injection practices, and Pr o g r ams: Findings of Four Case Studies. improving surveillance, the initiative strengthened the political and financial stability Special Initiatives Report 26. Bethesda, MD: of the programme. Among other actions, the government: Partnerships for Health Reform Project, Abt Associates ● More than doubled its own spending between 1999 and 2001, from US$1.15 M to an estimated US$3.5 M; ww w. Va c c i n e A l l i a n c e . o r g / f i n a n c i n g / p d f / fo u r _ c o u n t r y.p d f ● Committed itself to increasing its support to the programme by $500,000 a year progressively as external agencies reduce theirs; (3) Levine, Ruth, Magdalene Rosenmöller, ● Introduced a line item for immunization into the budget; and Peyvand Khaleghian. April 200 1. ● Imposed a tax on the national Social Security Agency with the proceeds Financial Sustainability of Childhood earmarked for vaccine purchase; Immunization: Issues and Options. Commissioned by the GAVI Financing Tas k ● Introduced performance-based contracts with local governments to encourage For c e competition between areas for the highest coverage rates; ww w. Va c c i n e A l l i a n c e . o r g / r e f e r e n c e / ● Signed a memorandum of understanding with the Interagency Coordinating fs c i _ e x e c s u m m . h t m l Committee for the next phase of the initiative, up to 2005. By 2000, coverage for three doses of diphtheria, tetanus and pertussis (DTP) was (4) Tambini, G. presentation at (1) and up from 75% in 1997 to 89%. Combination vaccine including DTP, Hep B and Hib Annex, Project Appraisal Department, Phase now reaches 75% of the population. And the number of municipalities with low II – Bolivia Health Sector Reform Project, coverage has dropped by two-thirds. Source: (4) World Bank; can be viewed on PAHO site in EPI Newsletter at definition, it could give sy s t e m ’ s framework, but is ww w. p a h o . o r g / E n g l i s h / H V P / H V I / governments in developing broadly supportive of the sn e 2 302 . p d f countries more flexibility about ar guments put forward by Dr how to approach their plans for Levine and her colleagues. *N O TE: “Immunization performance” is sustainable financing – and it For the US, too, there is defined in terms of current and future goals could also mean that donors increasing recognition that the for access, utilization, quality, safety and become more engaged in those long-haul approach makes sense, eq u i t y. plans. If all parties use the although no one imagines it will planning process as a real be easy to achieve. “We 4: What should be in a op p o r t u n i t y , rather than a “All partners are acknowledge that this is sustainability plan? bureaucratic exercise, sharing some the way it is going to Suggestions from Bangladesh, Benin, says Dr Levine, real have to be, because there responsibility for Ukraine and Zimbabwe for the content progress can be made. are no reasonable the function of of governments’ plans include: So what do the donors alternatives in the short the programme ● themselves think about term,” says Steve An assessment of current conditions affecting the service the new thinking on now” Landry at USAID. It sustainability? Im m u n i z a t i o n will mean that donor agencies’ ● Projected resource needs for first 1- Fo c u s approached officials in st a f f at country level, who serve 2 years after the Fund awards end several donor agencies. Th o s e on Interagency Coordinating ● A plan for implementing the service who responded were generally Committees, will engage more in those first years positive. , which last year actively than before as real ● Statements of 5- to 7- year committed $125 million to GAVI , partners with the government. commitments from (a) government has long believed in long-term “The whole concept of the ICC is and (b) partners investment in countries. Its that now all the partners are ● An identification of potential programmes with countries sharing some responsibility for the problems ahead (such as devaluation) typically last at least 10-15 years, function of the programme, in ● Plans for different scenarios, based says Rune Lea, health adviser in explicit terms, and they have to on different financial commitments by the Norwegian Agency for engage on a routine basis in government and partners Development Cooperation. Th e working with the government to ● Strategies for mobilizing funds from aim is to invest in human capital, take this on.” In other words, the (a) external (b) domestic and (c) through health and education, as a future of immunization is private sources way to build each country’s ev e r y o n e ’ s responsibility. ■ ● Measures for cost savings capacity towards eventual self- Re f e r e n c e s : ● Plans for staff training and capacity su ff i c i e n c y . Dr Lea warns that a building at national and district levels truly sustainable immunization (1) Immunization Finance Sustainability Plans. Workshop 4-6 June 200 1, Geneva, ● Endorsement by (or Memorandum programme will need to be hosted by WHO, cosponsored by USA I D and of Understanding with) the Interagency planned within the overall health the Bill and Melinda Gates Children’s Coordinating Committee

GAVI Immunization Focus • June 2001 • Page 8 of 10 Immunization Focus BRIEFING Good management means good measurement

All countries need to be able to measure the performance of their national immunization services accurat e l y . The World Health Organization and the Bill and Melinda Gates Children’s Vaccine Program at PATH have developed a new tool called the Data Quality Audit (DQA) to help countries check whether their information systems are working well. Sp e c i f i c ally, the DQA will assess whether nationally reported data accurately reflect the number of children being immunized and recorded at district level. As auditors begin training this month in the use of the DQA in Ken y a , Uganda and Pakistan, John Lloyd explains why it matters and how it works

Why do we need the DQA ? became clear that progress in countries, depending on evidence There are three good reasons why reaching more children with of the quality of reporting systems the Data Quality Audit (DQA) is vaccines should be verified and the size of the Fund grant. needed to audit the system that an n u a l l y . How does it work? reports on the performance of How will the audit ensure The DQA country visit focuses on immunization services in each independence and tran s p a r e n cy ? reporting practice in a sample of co u n t r y . The DQA is external and four districts and six health First, managers of immunization independent both of the national centres in each district – 24 health services need correct and timely management and the local staff of centres in all. The auditors check information to detect the GAVI partners. The procedure the accuracy of rec o rd i n g of the improvement or decline in is carried out by a team of number of , the performance. Second, the partners international experts in private- transcription and aggregation of of the GAVI Alliance working at and public-sector auditing and in these numbers and the rep o rt i n g all levels need reliable the field of public health. Th e from level to level of the system. information to judge the impact of procedure, which lasts two to The audit focuses mainly on one new efforts and new resources on three weeks, may be carried out in key indicator of performance: the performance. Third, GAVI and the any country receiving assistance number of children who receive a Fund award money to countries to from GAVI and the Fund. But in third dose of diphtheria, tetanus improve their immunization practice, it is probable that it will and pertussis (DTP) vaccine. Th e services according to a system of be applied to a third DTP dose, known as DTP3, “shares”, one share being earned selection of is chosen because, though not by the country for each perfect, it is considered the most additional child reported to reliable measure of the number of have been immunized fully protected children. relative to the previous A country may state in its reports ye a r . The Fund can only to WHO, UNICEF and GAVI that reward governments on the a certain number of children basis of children who have received DTP3 in a given year. been correctly recorded This number may include children and reported as immunized. wh o : So, the DQA aims to: ● are thought to have received ● Assess the quality, accuracy DTP3 but were never recorded; or and completeness of ● received DTP3 and were administrative immunization recorded and reported; or reporting systems; and ● received DTP3 and ● Provide practical feedback were recorded but never to health staff on how to reported; or improve the quality of ● were reported to have reported data. received DTP, but were Where did the idea come never recorded. ◗ fr o m ? The DQA was born last summer, at the start of the Fund ap p l i c a t i o n process, when it Hold onto it: the immunization record card is vital for an effective system ©UNICEF/HQ92-0363/Giacomo Pirozzi GAVI Immunization Focus • June 2001 • Page 9 of 10 Immunization Focus New resources…New resources …New resources … New resources The DQA does not substantiate What next? Strengthening immunization programmes: the first group of children as Dr Linda Ar c h e r , a WH O Practical workshop guides for immunization having been immunized. But it consultant based in Nairobi, has professionals does assess the ability of the developed successive drafts and administrative reporting system to refinements of the DQAthat have The GAVI partners have created a set of six guides for count and report correctly those been tested in Kenya and Sri workshop facilitators, focusing on strengthening immunization programmes and management systems. These children that were recorded at the Lanka. Now, the latest revision of practical guides can be adapted for workshops in different site of immunization. Since (1 ) the DQA manual is ready . Th e regions or countries. Key topics covered by the guides include awards will be made on the basis GA VI partners decided to search the development of in-country coordinating mechanisms, of the additional number of for a suitable organization to immunization programme assessments, multi-year plans, and children relative to the previous implement the audit, and after a financing. year who are recorded as having tendering procedure they chose a The guides were developed for a workshop held in Annecy, received DTP3, there is a strong consortium headed by Liverpool France, in April to update immunization professionals on "the incentive to reduce the first group Associates in Tropical Health, GAVI approach" to strengthening immunization services. of children – those who were UK, a body associated with the Participants were nominated by their regional working groups immunized but never recorded – Liverpool School of Tro p i c a l and came from Africa, Asia, the Newly Independent States and the Middle East. They represented national ministries of to zero. Medicine with a strong research health, WHO, UNICEF, the World Bank, PATH and the knowledge base and global What else does the DQA check, Association Pour L'Aide à la Médicine Préventive (AMP). As a and how does it help countries? experience in health assessments result of the Annecy workshop, participants from the regional In addition to re-counting and and evaluations. The training of working group in west Africa have already scheduled their checking the data, the DQA auditors begins this month in own localized versions of the course to be held in Abidjan in judges the overall reliability and Kenya, Uganda and Pakistan and August. The GAVI partners anticipate similar activities in other timeliness of the reporting system, then six other countries will be regions. The workshop facilitator guides, supportive materials, and using a set of standard indicators. visited by September 2001. Each further information about the Annecy workshop are available For example, it looks at the year thereafter, a proportion of countries that receive assistance at: www.childrensvaccine.org/html/gavi_annecy_training.htm proportion of records that get lost or by mail or email from Molly Mort, PATH, 4 Nickerson and the proportion of reports that from GAVI and the Fund will be ■ Street, Seattle, Washington 98109, USA. [email protected] arrive late. If the child’s visited by DQA auditors. immunization cards are lost, the Sustainable financing: Resources from the GAVI Financing Task Force wrong vaccine dose may be given (1) Copies may be requested by email from and recorded. Late reports result Lisa Jacobs at the GAVI Secretariat: The GAVI Financing Task Force (FTF) has produced a set of in incorrect aggregations and lj a c o b s @ u n i c e f . o r g briefing materials and analyses for use by national coverage calculations at higher governments and other stakeholders. The resources are levels. There are many pitfalls John Lloyd is Resident Adviser at the intended to support decision-makers in areas such as: that can be avoided if the critical European office of the Bill and Melinda identifying long-term financing options for immunization elements of quality are in place. Gates Children’s Vaccine Program , programmes; promoting the development of new vaccines for This information enables the implemented by PATH. Dr Lloyd took part low-income and middle-income countries; forecasting vaccine demand; and capacity building in financial management. auditors to offer advice to the in the creation of the DQA concept, the development of the methodology and The analyses and briefings have been commissioned from a health workers, managers and has participated in the testing and the range of independent experts and include background and national leaders of immunization. tr aining of auditors. discussion papers and case studies on the financing of DQ A is a powerful capacity immunization services, and a model for forecasting vaccine building block for each nation’s demand. A vaccine finance policy “briefcase” is also being health management information prepared. The first materials, together with details of the FTF system and is a good example of and its scope of work, are available on the GAVI website at the way in which GAVI can www.vaccinealliance.org/financing/intro.html; these will be strengthen the health system. updated and added to regularly. Immunization Focus Editor: Phyllida Brown GAVI Editorial Adviser: Lisa Jacobs Fund Editorial Adviser: Victor Zonana Publisher: Dr Tore Godal, GAVI Secretariat, C/O UNICEF, Palais des Nations, 1211 Geneva 10, Switzerland. Email: [email protected] External Editorial Board: Maria Otelia Costales, UNICEF, New York, USA; Shawn Gilchrist, Vaccine Industry Representative, Aventis Pasteur, Toronto; Keith Klugman, Emory University, Atlanta, USA; P. Helena Mäkelä, National Public Health Institute, ; Philip Minor, National Institute for Biological Standards and Control, ; Khadija Msambichaka, ; Francis Nkrumah, Noguchi Memorial Institute for Medical Research, ; , The Children’s Hospital of Philadelphia, United States and Member, Advisory Committee on Immunization Practices; Mohammed Ashraf Uddin, Chief Health Officer, Dhaka City Corporation, Bangladesh The views expressed in Immunization Focus are not necessarily the views of the GAVI Board. Designed and produced by: Synergy New Media, London N17 9LN, UK. http://www.synergynewmedia.co.uk

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