For Immediate Release
Office of the Press Secretary
June 10, 2004
G-8 Action on Global HIV Vaccine
G-8 Action to Endorse and Establish a Global HIV Vaccine Enterprise
1. We reaffirm our commitment to combating the global HIV/AIDS
pandemic. Both individually and collectively, we have increased our
efforts aimed at HIV treatment, care, and prevention. We acknowledge
the important role of the Global Fund to Fight AIDS, Tuberculosis, and
Malaria, UNAIDS, and WHO in fighting this pandemic. But the human and
economic toll of the AIDS pandemic demands that these activities be
complemented by accelerated efforts to develop an HIV vaccine. In 2001
and 2002, only seven vaccine candidates entered clinical trials, and
only one entered advanced human testing, but proved to be ineffective.
Vaccine development efforts have proceeded slowly, due largely to the
enormous scientific challenges. The best way to meet these challenges
is for scientists around the world to work together in a complementary
manner.
2. We believe the time is right for the major scientific and
other stakeholders -- both public and private sector, in developed and
developing countries -- to come together in a more organized fashion.
This concept has been proposed by an international group of
scientists. Published as a "Policy Forum" in Science
magazine. Klausner, RD, Fauci AS, et al: "The
need for a global HIV vaccine enterprise." Science 300:2036,
2003. We endorse this concept and call for the establishment
of a Global HIV Vaccine Enterprise - a virtual consortium to accelerate
HIV vaccine development by enhancing coordination, information sharing,
and collaboration globally.
3. The Enterprise should establish a strategic plan
that would prioritize the scientific challenges to be addressed,
coordinate research and product development efforts, and encourage
greater use of information sharing networks and technologies. This
plan should serve as a blueprint for helping to align better existing
resources and to channel more efficiently to the needs at hand new
resources as they become available. Specifically, the strategic plan
should seek to:
3.1. Encourage the development of a number of coordinated
global HIV Vaccine Development Centers: Each center should have
the critical mass and scientific expertise to advance the development
of a particular HIV vaccine approach. These centers could be
self-contained, as is the National Institute of Allergy and Infectious
Diseases (NIAID) Vaccine Research Center at the U.S. National
Institutes of Health, the European Research Institutes or could be
virtual centers, such as those funded by the public-private
partnerships of the International AIDS Vaccine Initiative (IAVI), the
European Developing Countries Clinical Trials Program (EDCTP), the
Gates Foundation, and others.
3.2. Stimulate the development of increased dedicated HIV
vaccine manufacturing capacity: There is inadequate existing
capacity to produce HIV vaccines for advanced clinical testing.
Therefore, the resources and facilities involved in manufacturing
potential HIV vaccines must be increased, particularly for testing of
vaccine candidates that are currently in or will soon be in the
developmental pipeline, like in the EDCTP.
3.3. Establish standardized preclinical and clinical
laboratory assessment: Data gathered from clinical trials on a
given vaccine candidate should be available and applicable to trials
being conducted on other vaccine candidates. Therefore, standardized
protocols and measures of effectiveness need to be adopted at the
preclinical and clinical stages of vaccine development. In turn,
laboratories need to be better linked to clinical trials, which will
require wider use of novel confidentiality agreements and
information-sharing technologies.
3.4. Expand an integrated international clinical trials
system: Large, clinical programs capable of conducting phase I,
II, and III trials of potential HIV vaccines have been established by
the U.S. NIAID, France's Agence Nationale de Recherches sur le SIDA,
Italy's National AIDS Program, IAVI, and the EU. This global clinical
trials system should be expanded and coordinated. It should facilitate
a multidisciplinary approach which draws in inputs from social and
behavioral scientists, alongside biomedical teams.
3.5. Optimize interactions among regulatory authorities:
Increased cooperation, communication and sharing of information among
regulatory authorities in various countries and regions involved in
licensing HIV vaccines are essential. This can be accomplished without
reducing safety or manufacturing standards.
3.6. Encourage greater engagement by scientists from
developing countries: Since most phase III trials will need to be
conducted in the developing countries hardest hit by the disease, the
international clinical trials system must involve local scientists,
ethical review committees comprised of local and international
representatives, and regulatory bodies.
4. We call on all stakeholders in the Global HIV Vaccine
Enterprise to complete the development of this strategic plan by our
next Summit.
5. The United States, in its role as president of the G-8,
will convene later this year a meeting of all interested stakeholders
in the Enterprise to encourage their collaborative efforts in HIV
vaccine development. This meeting should clarify how the strategic
plan is to be implemented. We support this conference becoming an
annual event and we look forward to a report on the follow-up of the
Initiative at the next G-8 Summit.
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