When the Global Alliance for Vaccines and Immunizations (GAVI)was founded in 2000, it pioneered a new model for accelerating thedelivery of public health commodities to developing countries.Specifically, the Alliance seeks to increase coverage of basicchildhood immunizations in low-resource settings that have longlagged behind in being able to provide these vaccines, whichinclude combinations like measles-mumps-rubella anddiptheria-tetanus-pertussis (DTP), and hepatitis B. Working withthe Vaccine Fund, a sister organization which mobilizes the fundsto buy and deliver vaccines rapidly, GAVI supports programs in 60of the world’s 74 poorest countries. Two years after its launch,it is the elder statesman in a global health arena now alsopopulated by similar new models, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM).

Tore Godal is GAVI’s Executive Secretary. A Norwegian-bornimmunologist, he is former head of the UNDP/World Bank/WHO SpecialProgramme for Research and Training in Tropical Diseases (TDR),and has also served as the initiating project manager for the Roll Back Malaria Project and as special advisor to Gro Harlem Brundtland,Director-General of the World HealthOrganization. In this discussion with IAVI Report SeniorWriter Emily Bass, he describes what GAVI has learned aboutestablishing effective vaccination programs in developingcountries and how these lessons could apply more generally toprograms that might follow in its footsteps, including the GFATMand future AIDS vaccine distribution schemes.

In 1999, GAVI laid out several concrete milestones. How have youfared in terms of meeting these goals?

We have the same milestones that were set in 1999--for example,that by the end of 2002, 80% of the poorest countries withadequate delivery systems will introduce hepatitis BB vaccine, andby 2005, 80% will have at least 80% coverage with routineimmunizations in all districts. [Editor’s note: Countries aredeemed to have adequate infrastructure if they already provide atleast 50% DTP coverage.]

We are pretty much on target. So far, 40 out of 47 countries withadequate infrastructure are in the process of introducinghepatitis B vaccine--that’s just over 80%.

That must be very gratifying.

It looks promising, I must say. But I’m sure that some countrieswill not perform as they have laid out in their proposal and5-year plan, and then we will have to take action based on that.

We’re now entering the implementation phase—a rather exciting partof the process, where we will assess performance and act on theresults.

How will that be done?

We have selected one global indicator: DTP coverage. We assess this based on what we call a Data Quality Audit [conducted byindependent consortia that include the auditing firms PriceWaterhouse and Deloitte and Touche], a process of conductingvisits at a country level to gather data from the primary place ofimmunization upwards through the system. We visit randomlyselected sites, usually four districts in a country and six healthfacilities within each district. Then we compare these data withwhat the country is reporting in terms of their nationalimmunization coverage.

Are there specific elements or approaches that make a GAVI-fundedprogram likely to succeed?

We put our emphasis on countries’ achieving specific milestonesand then give them complete freedom as to how they accomplishthis. They can use the money they get from us however they want.What is interesting is that they have all decided to get moneydown to the district level as quickly as possible, because that isthe only way to get increased coverage.

What are some examples of specific countries or diseases whereGAVI-funded programs have been particularly successful?

One example is Tanzania, which was very systematic in itsapproach. They decided to take districts that were performingpoorly, but where they thought something could be done about it.The GAVI money went for per diems to the health workers and forbicycles and petrol, so that health providers could do betteroutreach.

In Ghana, they decided to spend the money on computers for healthfacilities, so they could improve their record system andimplement performance incentives for high-performing sites. And inKenya, they decided to transfer the money directly from theMinister of Health to the district medical officer and to adopt aperformance-based payment system that bypassed the normalgovernment channels, where money tends to get stuck betweenNairobi and the districts.

Where has GAVI not had as much impact as it hoped for?

There are countries such as Laos, where preliminary data suggestthat there may not be much progress. But we haven’t yet done theData Quality Audit for this year, so we don’t have the hard data.

Overall, we’re changing our focus. For the first two years, it wasa matter of receiving proposals. Now we’re setting policies forimplementation. We will get information from countries on how theyare doing, and we’ll respond depending on whether they aresuccessful or have problems reaching the targets they set forthemselves.

This is a different phase for GAVI, with different requirements.For example, it requires tighter management to ensure that GAVIgrants bring added value to the projects they fund, and lessinclusiveness in terms of who is involved in policy discussions.How does GAVI balance the need to move quickly against the time ittakes to build buy-in and decision-making structures in-country?

When GAVI started, the general picture was that aid moved veryslowly. We would hear about big numbers of available dollars, butwe would never see them. I remember the Minister of Health fromMozambique at a meeting saying, In 1988 we asked the World Bankfor a loan to the health sector, but we did not get an answeruntil 1994.

In contrast, GAVI and the Vaccine Fund were launched in January2000, and some countries received a first installment of financialsupport later that year. In April 2001 we introduced hepatitis Bvaccine in the first country, Mozambique. It’s true that we imposesome time constraints, but this is necessary to avoid having theprocess become too elaborate. Political leaders in the receivingcountries were very keen to get the funds, so they pushed to getthe technical assistance needed to develop their proposals quickly.

This year, a report on four GAVI-funded programs was published bySave The Children UK and the London School for Hygiene andTropical Medicine. One concern it raised was that Ghana waspressured to accept a pentavalent vaccine [containing hepatitis B,Haemophilis influenzae type B (Hib) and DTP] which was not theproduct they requested in their grant.

This is a case of inaccurate reporting. Countries have criticizedthat study for rushing in, collecting data and not discussing themwith authorities. Ghana’s Minister of Health has explained thatthe country had been considering the introduction of hepatitis Band possibly Hib for years, and that this pentavalent vaccine wasa deliberate choice on their part. He also said that Ghana isprepared to take over funding of the program after five years,when GAVI support comes to an end.

But we have seen some problems. Many countries say they wantcombination vaccines containing five shots in one, so they onlyneed to give one injection. This makes delivery much simpler. Whenwe started, we thought that obtaining these combination vaccineswas only a question of financing—that if we had the funds, then wecould deliver.

This has not turned out to be true. There is a limited productioncapacity for the different combination vaccines. So we had to makedecisions about which types of vaccines were given to differentcountries, and these were not always the combinations thecountries wanted. This created frustration. Countries thought theywould get something they couldn’t get.

The positive side is that industry has now responded by formingnew kinds of consortia and increasing production capacity. Butthis takes time. We will not see the increased capacity beforenext year or, more likely, 2004-05.

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What kinds of consortia? What specifically is happening?

I can give you one example. Chiron, a multinational company,produces Hib. Then there is Green Cross in Korea, which haspatents and licenses for hepatitis B, and BioPharma in Indonesia,which makes DTP. They have formed a consortium to produce apentavalent vaccine containing DTP plus Hep B plus Hib. Isn’t thata marvelous collaboration?

It certainly is. Where will the vaccine be made?

I think at BioPharma, but it is not completely clear. It’spossible that the vaccine will be produced in bulk in all threeplaces, and one place will fill the vials.

This type of partnership could be relevant to AIDS vaccines, forexample if a biotech company without production capacity developeda vaccine. This biotech could line up with a fairly sophisticatedproducer in the South that has a good manufacturing facility butno R&D capacity.

The London School report also raised the concern that GAVI is notproviding enough support to health infrastructure.

It is fair to say that the infrastructure in many countries ismore dilapidated than we had anticipated. For example, to deliverthe more advanced new vaccines, there is a clear need for moresupport to secure the cold chain [reliable storage facilities andtransport mechanisms for vaccines needing refrigeration]. Nowpartners are now coming in with this support as part of thealliance. GAVI cannot cover all infrastructure needs—ours is moreof a catalytic role. So UNICEF is stepping up its support for coldchains, and bilaterals like the Japanese Institute forInternational Collaboration (JAICA) are also stepping up.

In general there is more focus on immunization-related activities,I think, thanks to the establishment of GAVI.

What is the best constellation of stakeholders to start addressingtraining needs?

In my mind, we haven’t fully resolved the issues of capacitybuilding and operational research needs for an activity like GAVI.When we start doing disease-burden studies relating topneumococcal disease, to rotavirus disease, it will be anopportunity to build more long-term capacity. We’re stillpondering how to do this. One thing I would like to see is morepartnering between academic institutions in the North and theSouth.

How does the Vaccine Fund buy its vaccines?

The Vaccine Fund [VF] is contracted with UNICEF for specialprocurements on behalf of GAVI and the VF. Because this involvespurchasing large volumes of vaccines, we’ve halved the price ofhepatitis B vaccine, for example.

One of the lessons we learned is that if you can make multi-yearcommitments to industry, you are likely to get better prices andservices. We will now move into a multi-year commitment toproduction. This means that if there is shortage of a vaccine,[the purchaser] is guaranteed to get whatever cut of the availablesupply was paid for—the industry partner cannot go and sell thevaccine to somebody else who is willing to pay more.

How are vaccine prices negotiated?

It’s an open, competitive process among the manufacturers.

Is the process different for new vaccines which have not yetrecouped development costs?

The process is similar, although the prices would be higher.Whether this will stay the same in the future or not is a topicfor more discussion among the manufacturers and purchasers.

What practical advice do you have for AIDS vaccine stakeholderswho are thinking ahead to possible procurement schemes?

You need to define the specific countries for which your reducedprice procurement is valid. We have defined it as the world’spoorest countries, and we then say to industry, ‘We are not goingto interfere with the prices of this vaccine in middle or higherincome countries.’ We are not trying to set a price standard forthese other markets—we’ve explicitly agreed to segmented marketsat different prices.

How do you think a future AIDS vaccine be financed?

The Vaccine Fund is seen by donors as the global commodityfinancing mechanism for vaccines. We have learned from vaccineprocurement so far that it is advantageous to have a singlemechanism for securing the desired products at the best prices ina timely fashion.

Will GAVI play a role in distributing an AIDS vaccine?

We see the most strategic role for GAVI as preparing the groundfor a future AIDS vaccine. Countries need to strengthen theirhealth systems today to ensure rapid delivery of an AIDS vaccineas soon as one becomes available. And the global community needsto be convinced of the high value of vaccines in general, so theywill commit the necessary resources for development and eventualpurchase of an AIDS vaccine.

Finally, GAVI is focused on the development and introduction ofnew technologies that will improve access to vaccines—such asreduced reliance on the cold chain and, ultimately, eliminatingthe use of sharps.

Are there efforts underway to help countries make plans for howthey will sustain GAVI-funded vaccination programs after theirfive-year grant ends?

After five years GAVI and the VF would like to move on to financenew vaccines that come on the horizon, including an AIDS vaccine.So it is important that countries take on the financing for basicvaccines now covered by GAVI. We have guidelines for countries onhow to develop sustainability plans.

One thing we try to do is to link countries’ immunization needsinto broader initiatives like poverty reduction strategies. Forexample, in Tanzania, the budget for immunization is being tripledover the next 2 years, thanks to a link with a poverty reductionstrategy that includes immunization coverage as an indicator.

Have there been changes for GAVI since 9/11, for example, in thearguments you make, or the questions you need to answer?

Yes, 9/11 has meant some changes for the vaccine field. One isthat there is now development of vaccines against bioterror. Thiscan threaten some of the capacity for producing routine vaccines.I think it is only limited competition, but it has been flagged asa potential concern.

The second point is that eradication goals have been weakened. Ithink the possible reintroduction of smallpox vaccination willinfluence decision-making, for example about polio—there areincreasingly arguments that we should continue to vaccinate, evenafter polio has been eradicated—or about whether we should go formeasles eradication.

On the other hand, all this opens up new opportunities fortechnology development, and for the delivery of vaccines.

GAVI is working on two projects that will create resources for thefield--an immunization financing database and a ‘Lessons Learned’study. Can you describe these projects?

The idea behind the Lessons Learned study is that we want togather the lessons from each individual step. For example, we wantto learn from the first procurement round so we can do better inthe next round, which is coming up next year.

The Lessons Learned study also provides more detailed informationabout the vaccine industry, including earnings, markets, andactivities of producers in the North and South. We had only astudy from 1993 to build on. So it was important to get updated.

The immunization financing database will be an important guide towhat we can ask in terms of country-level and internationalsupport for immunization programs. And it will be helpful to showhow we fare in relation to mobilizing general support forimmunization services.

How is GAVI working with the Global Fund to Fight AIDS,Tuberculosis and Malaria?

We have been participating closely in the development of theGlobal Fund, though not everything we proposed has taken hold.

We suggested that it would be good to have a defined number ofcountries. But that was not accepted. Another suggestion was tohave clearly defined criteria as a baseline against which tomeasure progress. And we proposed that there be a short list ofbasic indicators like those developed by other programs, such asUNAIDS, Roll Back Malaria or StopTB. That was not approved either.I think this will be a challenge to the Fund—they want to beperformance-based, but they didn’t make the hard decisions neededto actually make it performance-based. But with Richard Feachem onboard [as the Fund’s new head], I’m sure things will change.

How important is political will in the work that GAVI does?

One of the gratifying things about the whole process has been thepolitical commitment, both in the North and in developingcountries. It’s amazing. Vaccines are now seen as something likewater and sanitation they should be available to everybody.

Copyright 2002 International AIDS Vaccine Initiative info@iavi.org