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HIV Vaccine Focus of Senate Panel

On June 23, the Senate Committee on Foreign Relations held a hearing on HIV/AIDS and the development of an HIV vaccine.

Chair Richard Lugar (R-IN) described the scope of the HIV/AIDS crisis: “According to the latest figures from UNAIDS, there are approximately 40 million people living with HIV/AIDS around the world today. An estimated 4.9 million people were newly infected last year. This means that every day around the globe, some 14,000 people contract HIV/AIDS.” Noting that “an effective HIV vaccine is the world’s best chance to stop this pandemic,” Sen. Lugar described the 2004 launch of the Global HIV Vaccine Enterprise, designed to promote collaboration on HIV vaccine research, and said that a resolution he has sponsored (S. Res. 42) “urges the President to work with the G-8 countries to support the Enterprise’s efforts.”

House resolution (H. Res. 286) sponsor Rep. Peter Visclosky (D-IN) testified before the committee, asserting, “Without increased resources and coordination, the development of a vaccine remains unlikely. S. Res. 42 and H. Res. 286 are an important first step towards the coordination of efforts on vaccine research.” Rep. Visclosky pointed out that HIV/AIDS also has devastating results in the United States: “Today, AIDS is one of the top three causes of death for African American men and women. This is an epidemic that is affecting the security and public health of our nation, and Congress has an obligation to do something about it.”

Highlighting the “urgent need to do more for young women around the world,” Population Services International (PSI) YouthAIDS Global Ambassador Ashley Judd stated, “In Africa, young women are up to six times more likely to become infected with HIV than their male peers. Little, if anything, is being done to address the problems that put young women at such high risk, and more must be done now if we honestly hope to stop the AIDS epidemic.” Ms. Judd told the story of a group of Zambian girls, ages 15-19, who met with PSI staff last year. Three of the ten girls had been raped; five others had experienced or barely escaped sexual violence. “Recent research confirms that these young women’s stories are not isolated cases,” she said. “A report published in 2002 concluded that nearly one out of three young women surveyed in South Africa had their initial sexual experience through rape. What more sordid and cynical rite of passage to adulthood could we imagine for a young woman?”

Ms. Judd denounced the practice of “cross generational sex,” in which young women sell themselves to older men “for modest financial support such as lunch, a cell phone, plastic shoes, or half a liter of fuel.” These relationships, she said, are particularly dangerous since “a young girl’s risk of HIV infection increases significantly as a result of having an older partner.” Though she cautioned that combating HIV/AIDS is “a long journey,” Ms. Judd made several proposals: 1) rejecting social norms that support the abuse of young women; 2) working “hand in hand with indigenous groups that are prepared to fight for change in their own communities;” 3) linking foreign aid “to a country’s demonstrated commitment to enforcing laws that protect women from all forms of sexual violence, including statutory rape;” and 4) launching campaigns which promote healthy male gender norms in Africa and other developing countries.

Describing the development of an HIV vaccine as “a scientific challenge as difficult as any we have ever confronted in infectious disease research,” National Institute of Allergy and Infectious Diseases Director Anthony Fauci stated, “NIH [National Institutes of Health] leads the Federal effort for the development and evaluation of HIV vaccine candidates; the U.S. Centers for Disease Control and Prevention, the Department of Defense, and other Federal agencies collaborate in this effort. In budgetary terms, the President’s Budget request for fiscal year 2006 for HIV/AIDS research at NIH is $2.9 billion. Of this, $607 million is for vaccine research and development; this figure represents a nearly six-fold funding increase for vaccine research over the past ten years and accounts for the majority of global HIV vaccine development spending worldwide.” Dr. Fauci highlighted the importance of international testing of a HIV vaccine and said that NIH partners with thirteen countries in its network of clinical research. He noted, “Since the 1980s, NIH has conducted a total of 85 clinical trials of candidate HIV vaccines in the United States and worldwide, involving more than 18,000 human volunteers.”

Dr. Fauci affirmed the role of the Global HIV Vaccine Enterprise, which allows researchers to “advance HIV vaccine research and development through the shared implementation of a globally developed strategic plan,” and explained that a key component, the Center for HIV/AIDS Vaccine Immunology (CHAVI), “will be a ‘virtual center’ that will link scientists at multiple sites into a single functional unit.” FY2006 CHAVI funding “is estimated to be as much as $49 million,” he said.

Bill & Melinda Gates Foundation HIV, Tuberculosis, and Reproductive Health Director Helene Gayle stated that support for HIV vaccine research “is a critical part of our broader global health agenda, which focuses on a fundamental commitment by Bill and Melinda Gates to global health equity,” and clarified that the foundation helped establish the Global HIV Vaccine Enterprise and now serves as the interim secretariat. Though the foundation recently announced “a commitment of up to $360 million over five years to fund work on scientific priorities identified by the Enterprise Plan,” Dr. Gayle emphasized that more funding is needed: “We hope that more resources are forthcoming, because a significant gap exists between resources currently available for vaccine research and amounts needed to finance a robust research effort.” She said that a “Funders Forum” will be convened in October “to bring together those currently funding HIV vaccine research with those that could potentially provide additional resources,” and she expressed her hope that the forthcoming G8 summit “will generate a reaffirmation of the G8’s commitment.” Dr. Gayle pointed out that involving the private sector in the development of an HIV vaccine is critical and stated that “support for programs that provide incentives for private companies to conduct global health research” needs to be increased. Additionally, she stressed the importance of “a comprehensive approach to HIV,” noting that “the expansion of prevention and treatment services for HIV is extremely helpful in our HIV vaccine research work.”

International Aids Vaccine Initiative (IAVI) President and CEO Seth Berkley explained that IAVI, whose mission is “to ensure the development and delivery of safe, effective, accessible vaccines to prevent HIV infection around the world,” was established “in 1996 to fill the gap between the public and private sectors and to establish an innovative new way of tackling global health crises.” Noting that scientific research needs to be partnered with product development and product applicability, he said that “we need to match the best in academic scientific research to the best in industry.” In addition to working with the private sector, Mr. Berkley stressed the importance of collaboration with “political, religious and community leaders in developing countries to ensure that once a vaccine is available, the vaccination effort succeeds at the grassroots level.” Mr. Berkley stated that “IAVI recently entered into our first product development agreement with a major global vaccine manufacturer to focus on vaccines designed to elicit responses against variants of HIV that circulate predominantly in Africa, although of course the ultimate goal of the collaboration is to develop vaccines that would be applicable worldwide.” He highlighted the need for more funding; incentives for the private sector such as advance purchase commitments, liability protection and tax credits; and proposed that the committee could “encourage PEPFAR [the President’s Emergency Plan for AIDS Relief], the Global Fund, and the World Bank to ensure that communities where critical prevention research is being conducted are prioritized for voluntary counseling and testing services and antiretroviral treatment.”

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