Policy Watch: Advocating for Improved AIDS Vaccine Policies
These are hopeful days for AIDS vaccine research. After over a decade of false starts and lackluster efforts in the public and private sectors, scientists are now more optimistic about prospects for a vaccine than ever before.
Fortunately, there is growing political interest in speeding AIDS vaccine research and delivery, and addressing the multiple ethical concerns raised by vaccine clinical trials.
In Spring of this year, the pharmaceutical company Merck announced that its DNA-based AIDS vaccine appears to prevent progression to disease in monkeys. The local biotech company VaxGen has AIDS vaccines in two large scale human trials. Many other experimental AIDS vaccines are in the pipeline to be tested.
Yet, for all the progress and expectation, there remain fundamental mysteries in the AIDS vaccine effort. Will DNA vaccines work in humans as well as they do in monkeys? Will enough new products make it through early testing to reach efficacy trials? Will industry expand research efforts to accelerate discovery of an effective product? Who will buy and distribute an AIDS vaccine for people both in the U.S. and in developing countries?
The answer to some of these questions must wait for advances in science and clinical testing. Other challenges, however, need to be met by advocates and policy makers. The AIDS Foundation has been actively engaged in promoting policies to address these issues.
One area of focus for SFAF and other vaccine advocates is speeding up the development of an AIDS vaccine. In 1996, former President Bill Clinton challenged the nation to create an AIDS vaccine within ten years. Since that time, U.S. government funding for AIDS vaccine research has increased at a steady pace, to $282 million in 2001, and the new Vaccine Research Center on the National Institutes of Health (NIH) campus has set to work on targeted AIDS vaccine research.
Despite this progress, the lack of a guaranteed profitable market keeps private industry -- including both large pharmaceuticals and smaller biotech companies -- from engaging fully in vaccine research and development. Legislation in the U.S. Congress has been designed to address some of these disincentives. The Vaccines for the New Millennium Act, introduced by Rep. Nancy Pelosi (D-San Francisco) and Senator John Kerry (D-MA) would provide tax incentives for research and development on vaccines and microbicides for the most deadly infectious diseases in the world, including AIDS, malaria, and TB. The Pelosi-Kerry legislation would also create a purchase fund for such vaccines (to ensure that funds are available to pay for a vaccine once it is developed) and would provide a tax credit on the sale of vaccines for delivery in lower income countries.
Last year, Congress passed some provisions of this legislation, including direct government funding for the International AIDS Vaccine Initiative (IAVI), which sponsors research on AIDS vaccine products particularly suited for use in the developing world. This year, major portions of the Vaccines Act were included in the tax bill passed by the Senate, but were ultimately removed in the final tax package. Rep. Pelosi and Senator Kerry are now looking for additional opportunities to attach the vaccine provisions to other legislation.
In addition to private industry and the NIH, the Department of Defense is also a critical player in the development of an AIDS vaccine. Promotion of public health may not be the first thing people think of when the U.S. Department of Defense (DOD) is mentioned. Nevertheless the DOD's HIV vaccine research program has a history of funding targeted AIDS vaccine product development, working closely with industry, and maintaining the facilities necessary to test HIV vaccines in multiple sites around the world. The DOD program also focuses on developing vaccines for strains of HIV found outside of the U.S. -- an important fact given that more than 95% of new infections are in developing countries.
The DOD HIV vaccine research program has been chronically underfunded, and earlier in the year DOD officials threatened to jettison the program to NIH. A coalition of health groups, including SFAF and the AIDS Vaccine Advocacy Coalition (AVAC), is advocating for $50 million for the program and is actively working to preserve AIDS vaccine research capability at DOD.
However, even if researchers succeed in developing an AIDS vaccine, additional challenges remain. It typically takes a decade or more for vaccines licensed in the Western world to reach populations in developing countries. Such a delay in delivering an AIDS vaccine would mean literally tens of millions of needless infections.
The Foundation is working with its partners at AVAC and IAVI to enact policy changes that will help to ensure timely delivery of an AIDS vaccine. First, billions of dollars of funding will be required to purchase a vaccine. The Global AIDS and Health Fund, launched earlier this year, could help purchase AIDS vaccines in the future, and we are working to ensure that this occurs. Second, major investment in health care infrastructure is needed in many developing countries, particularly since vaccine delivery systems must be retooled to reach sexually active teenagers and adults, in addition to children who benefit from current distribution programs.
Increasingly, AIDS vaccine priorities overlap with key issues in treatment advocacy. Purchase capacity and improving health care infrastructure are just two examples. Other shared issues include ensuring ethical clinical trials and providing quality informed consent to trial participants and pushing the U.S. government and industry to accept tiered pricing (drastically lower prices for lower income countries). Rethinking of patent agreements and regulations to maximize access to drugs and vaccines is also necessary. AIDS vaccine science and policy present myriad challenges. With encouraging news from research labs and growing public acknowledgement of the need for a vaccine, however, there is now reason to be hopeful an AIDS vaccine will bring the pandemic under control one day soon.
For more information on AIDS vaccine research and policy, visit the websites of the:
This article was provided by San Francisco AIDS Foundation. It is a part of the publication OUTReach. Visit San Francisco AIDS Foundation's Web site to find out more about their activities, publications and services.