When the Global Alliance for Vaccines and Immunizations (GAVI)was founded in 2000, it pioneered a new model for accelerating the delivery of public health commodities to developing countries. Specifically, the Alliance seeks to increase coverage of basic childhood immunizations in low-resource settings that have long lagged behind in being able to provide these vaccines, which include combinations like measles-mumps-rubella and diptheria-tetanus-pertussis (DTP), and hepatitis B. Working with the Vaccine Fund, a sister organization which mobilizes the funds to buy and deliver vaccines rapidly, GAVI supports programs in 60 of the world’s 74 poorest countries. Two years after its launch, it is the elder statesman in a global health arena now also populated 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-born immunologist, he is former head of the UNDP/World Bank/WHO Special Programme 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 Health Organization. In this discussion with IAVI Report Senior Writer Emily Bass, he describes what GAVI has learned about establishing effective vaccination programs in developing countries and how these lessons could apply more generally to programs that might follow in its footsteps, including the GFATM and future AIDS vaccine distribution schemes.

In 1999, GAVI laid out several concrete milestones. How have you fared 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 with adequate delivery systems will introduce hepatitis BB vaccine, and by 2005, 80% will have at least 80% coverage with routine immunizations in all districts. [Editor’s note: Countries are deemed to have adequate infrastructure if they already provide at least 50% DTP coverage.]

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

That must be very gratifying.

It looks promising, I must say. But I’m sure that some countries will not perform as they have laid out in their proposal and 5-year plan, and then we will have to take action based on that.

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

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 by independent consortia that include the auditing firms PriceWaterhouse and Deloitte and Touche], a process of conducting visits at a country level to gather data from the primary place of immunization upwards through the system. We visit randomly selected sites, usually four districts in a country and six health facilities within each district. Then we compare these data with what the country is reporting in terms of their national immunization coverage.

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

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

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

One example is Tanzania, which was very systematic in its approach. They decided to take districts that were performing poorly, but where they thought something could be done about it. The GAVI money went for per diems to the health workers and for bicycles and petrol, so that health providers could do better outreach.

In Ghana, they decided to spend the money on computers for health facilities, so they could improve their record system and implement performance incentives for high-performing sites. And in Kenya, they decided to transfer the money directly from the Minister of Health to the district medical officer and to adopt a performance-based payment system that bypassed the normal government channels, where money tends to get stuck between Nairobi and the districts.

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

There are countries such as Laos, where preliminary data suggest that there may not be much progress. But we haven’t yet done the Data 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 was a matter of receiving proposals. Now we’re setting policies for implementation. We will get information from countries on how they are doing, and we’ll respond depending on whether they are successful or have problems reaching the targets they set for themselves.

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

When GAVI started, the general picture was that aid moved very slowly. We would hear about big numbers of available dollars, but we would never see them. I remember the Minister of Health from Mozambique at a meeting saying, In 1988 we asked the World Bank for a loan to the health sector, but we did not get an answer until 1994.

In contrast, GAVI and the Vaccine Fund were launched in January 2000, and some countries received a first installment of financial support later that year. In April 2001 we introduced hepatitis B vaccine in the first country, Mozambique. It’s true that we impose some time constraints, but this is necessary to avoid having the process become too elaborate. Political leaders in the receiving countries were very keen to get the funds, so they pushed to get the technical assistance needed to develop their proposals quickly.

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

This is a case of inaccurate reporting. Countries have criticized that study for rushing in, collecting data and not discussing them with authorities. Ghana’s Minister of Health has explained that the country had been considering the introduction of hepatitis Band possibly Hib for years, and that this pentavalent vaccine was a deliberate choice on their part. He also said that Ghana is prepared 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 want combination vaccines containing five shots in one, so they only need to give one injection. This makes delivery much simpler. When we started, we thought that obtaining these combination vaccines was only a question of financing—that if we had the funds, then we could deliver.

This has not turned out to be true. There is a limited production capacity for the different combination vaccines. So we had to make decisions about which types of vaccines were given to different countries, and these were not always the combinations the countries wanted. This created frustration. Countries thought they would get something they couldn’t get.

The positive side is that industry has now responded by forming new kinds of consortia and increasing production capacity. But this takes time. We will not see the increased capacity before next year or, more likely, 2004-05.

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 has patents and licenses for hepatitis B, and BioPharma in Indonesia, which makes DTP. They have formed a consortium to produce a pentavalent vaccine containing DTP plus Hep B plus Hib. Isn’t that a 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 three places, and one place will fill the vials.

This type of partnership could be relevant to AIDS vaccines, for example if a biotech company without production capacity developed a vaccine. This biotech could line up with a fairly sophisticated producer in the South that has a good manufacturing facility but no R&D capacity.

The London School report also raised the concern that GAVI is not providing enough support to health infrastructure.

It is fair to say that the infrastructure in many countries is more dilapidated than we had anticipated. For example, to deliver the more advanced new vaccines, there is a clear need for more support to secure the cold chain [reliable storage facilities and transport mechanisms for vaccines needing refrigeration]. Now partners are now coming in with this support as part of the alliance. GAVI cannot cover all infrastructure needs—ours is more of a catalytic role. So UNICEF is stepping up its support for coldchains, and bilaterals like the Japanese Institute for International 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 addressing training needs?

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

How does the Vaccine Fund buy its vaccines?

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

One of the lessons we learned is that if you can make multi-year commitments to industry, you are likely to get better prices and services. We will now move into a multi-year commitment to production. This means that if there is shortage of a vaccine,[the purchaser] is guaranteed to get whatever cut of the available supply was paid for—the industry partner cannot go and sell the vaccine 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 yet recouped 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 topic for more discussion among the manufacturers and purchasers.

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

You need to define the specific countries for which your reduced price procurement is valid. We have defined it as the world’s poorest countries, and we then say to industry, ‘We are not going to interfere with the prices of this vaccine in middle or higher income countries.’ We are not trying to set a price standard for these other markets—we’ve explicitly agreed to segmented markets at different prices.

How do you think a future AIDS vaccine be financed?

The Vaccine Fund is seen by donors as the global commodity financing mechanism for vaccines. We have learned from vaccine procurement so far that it is advantageous to have a single mechanism for securing the desired products at the best prices in a timely fashion.

Will GAVI play a role in distributing an AIDS vaccine?

We see the most strategic role for GAVI as preparing the ground for a future AIDS vaccine. Countries need to strengthen their health systems today to ensure rapid delivery of an AIDS vaccine as soon as one becomes available. And the global community needs to be convinced of the high value of vaccines in general, so they will commit the necessary resources for development and eventual purchase of an AIDS vaccine.

Finally, GAVI is focused on the development and introduction of new technologies that will improve access to vaccines—such as reduced reliance on the cold chain and, ultimately, eliminating the use of sharps.

Are there efforts underway to help countries make plans for how they will sustain GAVI-funded vaccination programs after their five-year grant ends?

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

One thing we try to do is to link countries’ immunization needs into broader initiatives like poverty reduction strategies. For example, in Tanzania, the budget for immunization is being tripled over the next 2 years, thanks to a link with a poverty reduction strategy that includes immunization coverage as an indicator.

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

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

The second point is that eradication goals have been weakened. I think the possible reintroduction of smallpox vaccination will influence decision-making, for example about polio—there are increasingly arguments that we should continue to vaccinate, even after polio has been eradicated—or about whether we should go for measles eradication.

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

GAVI is working on two projects that will create resources for the field--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 to gather the lessons from each individual step. For example, we want to learn from the first procurement round so we can do better in the next round, which is coming up next year.

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

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

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

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

We suggested that it would be good to have a defined number of countries. But that was not accepted. Another suggestion was to have clearly defined criteria as a baseline against which to measure progress. And we proposed that there be a short list of basic indicators like those developed by other programs, such as UNAIDS, Roll Back Malaria or StopTB. That was not approved either. I think this will be a challenge to the Fund—they want to be performance-based, but they didn’t make the hard decisions needed to 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 the political commitment, both in the North and in developing countries. It’s amazing. Vaccines are now seen as something like water and sanitation they should be available to everybody.

Copyright 2002 International AIDS Vaccine Initiative info@iavi.org