Important note: Information in this article was accurate in September/ November 2000. The state of the art may have changed since the publication date. IAVI Report - September / November 2000
At the Durban meeting, IAVI released two new documents that present detailed global strategies for key areas in AIDS vaccines.
The first one, "Scientific Blueprint 2000: Accelerating Global Efforts in AIDS Vaccine Development," starts from the premise that relatively few of the many potential vaccine approaches have been actively pursued. The Blueprint also maintains that, despite a major increase in resources for AIDS vaccines over the past two years - both from industry and a few governments - the level of commitment, investment and effort is still inadequate. That applies especially to work on vaccines aimed at HIV subtypes circulating in the developing world; only now are more such products entering clinical trials (see article).
Specifically, the Scientific Blueprint calls on the global community to take the following steps:
Introduce 25 new vaccine designs into the development pipeline, compare them in head-to-head clinical trials, and move 6-8 of the most promising ones into efficacy (Phase III) trials. Since there is still no clear answer on which HIV antigens are needed to confer protective immunity, or which immune responses are required for protection, the fastest way forward is to pursue a variety of different designs in parallel. Head-to-head comparisons should form the basis for choosing the best 6-8 candidates to move forward into phase III trials.
Sharply compress timelines for vaccine development, especially by combining phase I and II trials into a single Phase I/II test and by conducting parallel (rather than sequential) clinical trials in high incidence areas of the world. Other areas to accelerate include vaccine site preparedness and the myriad steps involved in getting regulatory, political and ethical approvals for vaccine trials.
Increase spending globally by roughly $US1 billion above current levels over the next seven years. IAVI's role in this accelerated effort will involve adding four to eight new "vaccine development partnerships" to the four already supported, each of which aims to move a different vaccine product (all based on strains predominant in developing countries) into human trials. These partnerships - first proposed in IAVI's original "Scientific Blueprint" two years ago - bring together researchers designing a vaccine with developing country partners where the vaccine can be developed further and tested, and with manufacturers who can produce it.
Another major challenge, beyond developing an effective vaccine, will be to make it immediately available to people in the countries hardest hit by the AIDS epidemic Clearly, it is imperative to avoid a situation like that which exists for anti-retroviral drugs, which are far beyond the means of the vast majority of people in developing countries. The second IAVI blueprint, entitled "AIDS Vaccines for the World: Preparing Now to Assure Access," presents a strategy for addressing the many economic, political and logistical obstacles to immediate and widescale access in the developing world. By beginning to plan and act now, the Blueprint argues, the typical ten or twenty year delay in introducing new vaccines to poor countries can be avoided.
The Blueprint's global action plan calls for the following five steps:
Development of effective pricing and global financing mechanisms. This should begin with a system of tiered prices that make AIDS vaccines affordable in poor countries while allowing higher prices in wealthy ones, where companies can earn profits. In addition, mechanisms for ensuring that funds will be available to buy vaccines for developing countries should be established and supported now.
Development of mechanisms to reliably estimate demand for specific vaccines and to ensure sufficient production capacity to meet initial demand for an effective vaccine. This could be accomplished through an international body that monitors vaccine candidates in clinical trials and, for the most promising ones, instigates studies on their use and distribution outside the region hosting the trial. Comprehensive efforts to predict demand for a given type of vaccine are also critically needed.
Development of appropriate delivery systems, policies, and procedures for the most at-risk populations, especially adolescents and sexually active adults. This will be a major challenge for countries without well-developed health care systems, since their existing vaccine programs are aimed at infants and pregnant women; those at risk for HIV may have little contact with medical clinics. Creating systems for reaching these populations will demand strong commitment from international agencies, governments and other stakeholders.
Harmonization of national regulations and international guidelines governing vaccine approval and use. While safety standards must obviously be upheld, the myriad of different regulations creates serious bureaucratic obstacles that complicate both international clinical trials and the widespread licensing of effective vaccines.
Establishment of a mass vaccination program in developing countries for at least one under-used pediatric vaccine. This would demonstrate a global commitment to broad use of important vaccines and help establish confidence among those who will need to invest heavily in delivery systems for AIDS vaccines.
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©2000. The IAVI Report.
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