July 09, 2000
Action needed now to provide simultaneous access for rich and poor; Gates, Mandela and leading vaccine manufacturers embrace goal
DURBAN, South Africa –The development pipeline for AIDS vaccines was virtually empty two years ago. Today, there are promising products in development but still no plan to get any useful vaccine to the most affected communities in the world. The International AIDS Vaccine Initiative (IAVI) today issued a detailed working agenda for what must happen over the next five years to make an AIDS vaccine available to those at highest risk of getting the disease.
IAVI warned that failure to act promptly would repeat the tragedy of antiviral treatments, which are unavailable to most who need them. “Lack of forethought, lack of will, and the cost and complexity of the intervention means that ninety percent of those who need HIV drugs have no way of getting them. Can we imagine allowing the same to thing to happen with a vaccine to prevent AIDS?” asked Seth Berkley MD, IAVI’s president.
The blueprint, AIDS Vaccines for the World: Preparing Now to Assure Access, provides an overview of vaccine economics and concludes that the current 15-year delay in introducing new vaccines to developing countries constitutes “a colossal public health failure.” The IAVI report calls for sweeping changes in the way vaccines are produced, licensed, priced, purchased and distributed, and includes a five-point action plan for immediate implementation. (See IAVI’s Five-Point Action Plan to Assure Global Access to AIDS Vaccines.)
“The once-empty vaccine pipeline is beginning to move, with a number of promising approaches in development. We are increasingly optimistic that a vaccine will be ready in five to 10 years. If we are to reverse the world’s historic failure to get important vaccines to all who need them, we must begin work immediately,” Berkley said.
“With over five million new HIV infections each year, business as usual is simply unacceptable. A five-year delay could cost 20 to 30 million lives,” Berkley added.
He noted that vaccine production facilities alone take around five years to design, build, and put into full use, and that the size of the plants must be based on estimates of demand that do not yet exist. In addition, the world must build new delivery systems to reach adolescents and others at high risk of infection.
“Simultaneous introduction of new vaccines in the North and South has never been tried before. It will require political will and new levels of trust between the public and private sectors. We must learn new ways of doing business, while respecting intellectual property and providing adequate incentives for vaccine companies,” Berkley said.
Microsoft founder Bill Gates, whose Bill & Melinda Gates Foundation has focused its philanthropy on vaccine development and distribution, endorsed the new blueprint in a video released at the conference. The Bill & Melinda Gates Foundation has provided $26.5 million in funding for IAVI. Gates cited former South African President Nelson Mandela’s recent plea that “the poorest of the poor” be given immediate access to an AIDS vaccine once it is developed.
“The message to policymakers and pharmaceutical companies is clear: if we do not take action now, the quest for an AIDS vaccine could yield a scientific triumph but a humanitarian failure,” Gates said. “As Albert Sabin, the developer of the oral polio vaccine, said, `a vaccine that sits on the shelf is useless.’”
The blueprint was welcomed by some of the pharmaceutical companies most active in searching for a vaccine. Jean Stephanne, president of SmithKline Biologicals, one of world’s largest vaccine makers, said: "This report provides a thoughtful rationale for the urgent need to take extraordinary steps to make a future HIV vaccine available to those who need it in the developing world. The science of HIV is advancing and now is the time to improve the vaccine delivery infrastructure in the developing world and to create a global vaccine purchase fund. IAVI's work advancing HIV candidate vaccines and advocating policy changes is critical to making a future HIV vaccine accessible."
Sean Lance, chairman and chief executive of vaccine manufacturer Chiron Corp, called IAVI’s blueprint “a major contribution to the ongoing discussion in and between the public and private sectors.” Lance added: “We are more optimistic than ever that with recent technological advances, increasing public support, as evidenced by the Presidential Challenge, and the contributions by IAVI and others, an AIDS vaccine will become reality within this decade.”
Community leaders also welcome IAVI’s action plan. "Africans know that a vaccine is one of the important and realistic hopes for controlling HIV/AIDS," said Dr Moustafa Gueye, director of the African Council of AIDS Service. "I am convinced that a vaccine -probably a number of vaccines - will be developed. My big fear is that they will not be available in our communities because although we have the possibility to dedicate significant local resources towards addressing HIV and AIDS in Africa -- especially for something as important as vaccines, in fact nothing very different will happen, because the will to do so still does not exist within most of our leaders, not even a clear commitment to improve and support a scaling up of the necessary health infrastructures that would allow for, amongst other things, local vaccine trials and eventual distribution."
Gueye added that vaccine funds cannot be taken from prevention or treatment services which are already starved of resources in much of Africa. IAVI and ICASO (the International Council of AIDS Service Organizations) have a joint program to prepare communities for full participation in decisions about vaccine testing and deployment."
According to the new IAVI blueprint, historical experience demonstrates the need for concerted action to assure access. Although the international community has previously mobilized to eradicate or prevent serious diseases such as polio, in the last three decades the global community has have failed to provide universal access to critical new vaccines.
For example, even though a vaccine was approved in 1981 to prevent Hepatitis B, use of the vaccine is almost non-existent in the poorest countries and the disease that still kills more than one million people annually.
To a large degree, the slowness with which new vaccines are currently introduced in developing countries stems from the peculiar economics of vaccine development and adoption. To minimize their financial risks and maximize return, makers of new vaccines typically begin with limited production capacity and focus marketing efforts exclusively on industrialized nations.
After many years pass and production capacity and efficiency increase, vaccine prices begin to fall, at which point vaccine purchases for some developing countries become possible. Typically, a generation or more is required for new vaccines to obtain moderate levels of use in the poorest countries.
Such an approach, IAVI contends, is unacceptable in the case of AIDS. According to the IAVI blueprint, “At the current infection rate, even a five-year delay in introducing a preventive vaccine – a major improvement over current practice – would nonetheless mean up to 30 million needless infections.”
Ninety-five percent of all HIV-infected people live in developing countries, and HIV infection is expanding most rapidly in poorer regions of the globe. “We need to put in place the incentives for companies to serve the poorest populations immediately,” Berkley said.
To succeed where the world has previously failed, IAVI proposes a program of unprecedented global collaboration – between public and private sectors, developed and developing countries, and governmental and non-governmental entities and implemented prior to a vaccine being licensed. A key element of IAVI’s program to assure access is a firm commitment from richer nations to purchase vaccines for use in hard-hit developing countries.
IAVI calls for the tiered pricing of new vaccines so that poorer countries can pay sharply lower prices than industrialized countries. Tiered pricing must be made politically acceptable. This means that richer countries must accept that they will pay prices high enough to cover the costs of research while the poorest countries pay only a little over the cost of manufacture.
IAVI has required this tiered pricing strategy as a condition of its own investments in developing a number of vaccines. Each agreement requires that any successful product of the research be made available in developing countries at a small margin over realistic manufacturing costs.
IAVI’s blueprint also emphasizes the critical need to protect intellectual property and to protect vaccine makers’ rights to a satisfactory return on investment.
IAVI also proposes the creation of an international panel of experts to monitor HIV vaccine trials and to advise key governments and multilateral institutions of steps that must be taken to assure that new vaccines are actually used as soon as they are available.
Key activities include estimating global demand for each promising new vaccine, strategic planning to assure timely production capacity to meet worldwide demand, undertaking comprehensive education efforts to promote vaccination programs, and the development of policies and procedures to assure that vaccination efforts adhere to the highest ethical standards.
Varied national approaches to vaccine licensure must also be harmonized to facilitate swift worldwide availability.
Rapid introduction of HIV vaccines will not be possible without substantial preparatory work to create new vaccine delivery systems, which can cost more than the vaccine itself. As most current vaccines are delivered to newborns, existing delivery systems are unlikely to reach the adolescents, sexually active adults, and other high-risk groups to whom initial HIV vaccination efforts will be directed.
Assuring that such production capacity and delivery systems are in place will necessitate substantial international financial support, as well as country-specific efforts that build on the integral involvement of affected communities and non-governmental organizations.
The International AIDS Vaccine Initiative is an international non-profit scientific organization founded in 1996 whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world.
Until now, IAVI’s work focused on three areas: accelerating scientific progress, mobilizing political support through advocacy and education, and encouraging industrial involvement in AIDS vaccine development. With release of the new blueprint, IAVI adds a fourth program area: assuring global access. Roy Widdus, Ph.D., the principal author of the new blueprint and coordinator of the Children’s Vaccine Initiative has joined IAVI to work on this area.
IAVI is a collaborating center of UNAIDS. In addition to the Bill & Melinda Gates Foundation, its major donors include the governments of the United Kingdom, the Netherlands and Canada, the World Bank, and the Rockefeller, Sloan, and Starr Foundations.
Later this week IAVI will release an update to its 1998 Scientific Blueprint for AIDS Vaccine Development, a global strategic plan that has already resulted in the launch of numerous innovative vaccine candidates.
For further information, visit www.iavi.org.
THE INTERNATIONAL AIDS VACCINE INITIATIVE’S FIVE-POINT ACTION PLAN TO ASSURE SIMULTANEOUS, WORLDWIDE ACCESS TO AN AIDS VACCINE
The following points are contained in IAVI’s new blueprint entitled AIDS Vaccines for the World: Preparing Now to Assure Access.
1. Effective pricing and global financing mechanisms must be developed to assure that vaccines are promptly available for use where they are needed.
§ Key political leaders and institutions should join with the private sector in endorsing the use of a tiered pricing structure for AIDS vaccines that enhances access by enabling poorer countries to pay what they can afford and at the same time permits companies to obtain a satisfactory return on investment.
§ Global mechanisms to purchase and deliver vaccines for use in developing countries should be created, and the G-8 nations should immediately make credible financial commitments for the support of such mechanisms.
2. Mechanisms must be developed to make reliable estimates of demand for specific vaccines and to ensure creation of production capacity to permit accelerated worldwide access.
§ To ensure appropriate preparation and coordination for the swift introduction of a preventive vaccine, an international body should be convened to monitor and evaluate vaccine candidates undergoing testing.
§ Based on evaluation of available data regarding particular vaccines, appropriate utility studies should be commenced in regions where efficacy trials are not occurring.
§ Analytic studies are needed to inform decisions regarding introduction of AIDS vaccines in developing countries.
§ A comprehensive effort should be initiated immediately to assess and predict private market and public sector demand for HIV vaccines.
§ Based on sound estimates of demand, appropriate multinational and national financial institutions should collaborate with private industry and/or explore other mechanisms to ensure that sufficient production capacity exists to ensure worldwide introduction of new vaccines.
3. Appropriate delivery systems, policies, and procedures must be developed for adolescents, sexually active adults, and other at-risk populations.
§ Developed and developing countries, health experts, multilateral institutions, non-governmental organizations, and other appropriate parties should collaborate to design and establish vaccine delivery systems in developing countries.
§ Strategic plans should be developed—at international, regional, and country levels—to communicate and advocate regarding HIV vaccines. Such efforts should be directed to policy makers, the general public, and populations most affected by HIV/AIDS.
§ Model approaches to individual education, counseling and informed consent should be developed, piloted, and evaluated.
4. National regulations and international guidelines governing vaccine approval and use must be harmonized.
5. To demonstrate global commitment to effective worldwide deployment of important vaccines, immediate efforts should be undertaken—using approaches articulated in this document, and building on existing mechanisms, such as the Global Alliance for Vaccines and Immunization (GAVI) and the Global Fund for Children’s Vaccines (GFCV)—to achieve maximum use in developing countries of one or more currently underutilized non-AIDS vaccines.
§ Efforts should be undertaken to educate decision-makers and finance personnel about the cost-effectiveness of vaccines.
§ Existing vaccines that are safe, effective, approved, and used in developed countries should, where needed, be supplied to developing countries.