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Margaret McGlynn is the president and CEO of the International AIDS Vaccine Initiative (IAVI). In this guest post to mark HIV Vaccine Awareness Day, she writes about the potential impact of a safe and effective HIV vaccine around the world. The post originally appeared on the US Agency for International Development’s (USAID) Impact blog. Throughout my career, I have witnessed the tremendous power of vaccines to prevent sickness and save lives—delivering incredible victories for humanity against diseases such as polio, smallpox, and measles. These vaccines would not have been possible without the inspiration, persistence, and courage of researchers, volunteers, and health workers around the world. And so today, on HIV Vaccine Awareness Day, I join countless others around the world in reflecting on what it would mean to see AIDS consigned to a list of former pandemics. To achieve that goal, it is essential that we enlist the participation of researchers around the world in the design and development of HIV vaccines. Young researchers such as Gladys Njeri Macharia in Kenya—who has dedicated her career to exploring immune responses to HIV—will play an especially important role in that effort. And one day, critical scientific questions addressed by this research might help lead to an effective vaccine. Thanks to a USAID-supported program, Gladys Njeri Macharia is studying how rare individuals might be blocking HIV infection. Photo credit: IAVI New modeling data available today from IAVI and the Futures Institute, with support from USAID, illustrates how a safe, preventive HIV vaccine that is accessible and affordable can help us end the AIDS pandemic. This information is available in a series of publications and an interactive web tool. The potential impact of a vaccine is striking. Because HIV is so extraordinarily resistant to the immune response, it is highly unlikely that any single vaccine will be able to prevent infection by all variants of the virus. Still, our modeling shows that if an AIDS vaccine that is only 50 percent effective is introduced in 2020 to 30 percent of the population in low- and middle-income countries, 5.2 million new HIV infections could be averted over the first decade. Higher efficacy and more coverage would have an even greater impact on the pandemic. The world must continue to scale up and improve the response to HIV by using powerful prevention tools that are currently at our disposal. These include condoms, treatment, and voluntary medical male circumcision. Our new models show that a vaccine can build on these existing tools and take us down the last mile to the end of the AIDS pandemic. A 50 percent effective vaccine combined with greater use of current HIV-prevention tools could prevent nearly 20 million new HIV infections by 2030—20 million people that would not need to face the physical, emotional, and social hardships caused by the disease and could avoid lifelong, daily antiretroviral treatment to stave off AIDS-related illness or death. This HIV Vaccine Awareness Day, IAVI and our partners remember those we have lost to AIDS, gain inspiration from those living with and combating the disease today, and look forward to building on the incredible momentum of recent discoveries and study results to deliver on the tremendous potential of an AIDS vaccine. To access IAVI and the Futures Institute’s impact modeling publications and interactive modeling tool, visit www.iavi.org/

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. On HIV Vaccine Awareness Day, GHTC members the International AIDS Vaccine Initiative and AVAC have released new materials and data on the search for and potential impact of this new prevention tool. The House Appropriations Committee voted on its fiscal year 2013 State and Foreign Operations Appropriations bill and released a report that clarifies its funding intentions for global health programs. The GHTC and Policy Cures stress that all stages of research—from early science to the later stages of product development—are critical to the successful creation of new global health tools. A Food and Drug Administration advisory panel has recommended that the agency approve the first over-the-counter HIV test, a kit that could return results for consumers in the privacy of their homes.

Soma Ghoshal is a program officer with the Results for Development Institute. In this guest post, she writes about a recent event that examined a new World Health Organization (WHO) report on global health research and development (R&D) financing. The WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) recently released a new report, titled “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination.” The report lays out the working group’s vision for principles, policies, and a framework that should be embodied in a global R&D system to meet the needs of those for whom markets fail. On May 7, the Results for Development Institute, Georgetown University’s O’Neill Institute for National and Global Health, and the Harvard Global Health Institute co-hosted an event to debate and discuss this critical report—the first of its kind for a multilateral institution like the WHO. Held at the Results for Development Institute offices in Washington, DC, the event was attended by 65 interested R&D practitioners, policymakers, and other global health stakeholders. John-Arne Rottingen, the chair of the CEWG, kicked off the event with a keynote presentation emphasizing the need for better and more sustainable financing and coordination mechanisms for diseases affecting low- to middle-income countries. He mentioned four underlying concepts that should be the foundation of a global framework for health R&D: Affordable products can best be achieved through free open market competition in production. R&D costs and prices of products should be delinked. Upfront public financing of R&D is needed. R&D is reestablished as a global public good where there is need for collective action and agreed financing contributions to avoid free riding. Rottingen emphasized that these elements should be embodied in a global binding instrument such as an international convention or treaty. Much like the WHO Framework Convention on Tobacco Control, agreeing to convention for R&D with legal force and an associated financial commitment would be intended to represent a systematic and sustainable solution, brought about by collective political leadership. “This is the challenge for the world as a whole, which has guided our discussions and deliberations. We have framed our recommendations to indicate that finding solutions is the responsibility of all of us in this interdependent world, in developed and developing countries alike,” Rottingen said at the event. After Rottingen’s presentation, the first panel took the stage, moderated by Robert Hecht, managing director at Results for Development Institute. Discussants included: Nils Daulaire, Office of Global Health Affairs, Department of Health and Human Services. Judit Rius, Médecines sans Frontières Access Campaign. Paul Wilson, Results for Development Institute and Columbia University. Rachel Cohen, Drugs for Neglected Diseases initiative. A lively discussion ensued regarding the proposals for new funding and coordinating mechanisms. The timeliness of the report and the US Government’s involvement in global health R&D were also topics of discussion. Rius spoke about the concept of delinkage, or separating the cost of R&D from the end product price. She explained that high product prices reflect high costs associated with R&D, and by de-linking these two aspects, products can be made more affordable while R&D can still persist. Daulaire articulated the US Government’s stance on global health R&D, explaining that the US Government clearly has a vested interest in global health R&D, which has been plainly shown through its investments. While it is promising that there seems to be an emerging consensus about how to address global health R&D needs throughout the world, there is still much work that needs to be done to create a viable framework that moves beyond (successful) voluntary bilateral and philanthropic efforts to more sustainable global commitments. After a brief question and answer period, the second panel began its discussion, moderated by Larry Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. The panelists included: Suerie Moon, Global Health Institute, Harvard University. Benn McGrady, O’Neill Institute, Georgetown University. Jamie Love, Knowledge Ecology International. This panel discussion focused on the binding instrument and the implications of using legal force to bring about collective action for R&D. Topics discussed included the international treaty on tobacco control and the merits of using a binding instrument for R&D. Moon highlighted that treaty backers will have to consider whether to seek an instrument that is universal, and potentially weaker, or go for a stronger treaty that includes fewer countries. McGrady noted how a convention on R&D may sort out problems that have kept R&D investments low, such as a lack of mobilization of relevant interest groups and a challenge in establishing common norms by which different countries should abide. In addition, Love commented on the merits of broadening the mandate of the WHO R&D Convention to encompass more than just developing countries, but rather to go for a “big” R&D treaty that includes R&D for non-communicable and other diseases affecting developed countries. Love felt that broadening the treaty scope has the potential to address more global health needs, which may be attractive to US or European country governments trying to control health care costs in times of austerity and who may be more willing to join if the treaty is seen as beneficial to their own populations. The event concluded with the clear message that although arriving at a consensus that more attention needs to be paid to R&D is progress in and of itself, this moment must be leveraged appropriately, and there is much work that needs to be done.

On Thursday, the House Appropriations Committee will vote on a State and Foreign Operations (SFOPS) appropriations bill for fiscal year (FY) 2013, which will include funding levels for global health and other programs at the State Department and US Agency for International Development (USAID). This vote follows last week’s markup of the bill by the House SFOPS appropriations subcommittee. Overall, the subcommittee’s bill had mixed results for global health and other programs at USAID: while some programs were sustained at FY 2012 levels, others saw significant budget cuts that will affect the agency’s efforts worldwide. Under the subcommittee’s bill, the entire State and Foreign Operations account was cut by nine percent. Many bipartisan programs like the President’s Emergency Program for AIDS Relief (PEPFAR) were flat-funded at FY 2012 levels. USAID’s global health funding, which contributes to global health research and development (R&D) projects, was cut by six percent, a decrease of roughly $150 million. USAID’s operating budget was also slashed by 5%, which will affect all of its programs. No funding levels were outlined for the many disease-specific programs at USAID. These disease-specific funding levels could be added to later versions of the bill, or could be left up to the Obama Administration once the entire appropriations process is completed. The only exception was family planning, which was slashed by one-quarter and given a new overall funding cap of $461 million—$149 million below the FY 2012 levels. It’s important to remember that the final SFOPS budget for FY 2013 will probably look different from the House bill being considered this week. The Senate is working on its own version of the appropriations bill, and both versions will eventually have to be negotiated if Congress follows a typical appropriations process (which it hasn’t done in the past few years). Whatever the final SFOPS budget looks like, it’s critical that Congress fully funds USAID so it can continue its work in all areas of global health, including the agency’s support of R&D to develop new health tools. And if it’s left to the Administration to make decisions about disease-specific program funding at USAID, funding for R&D and innovation for all disease areas needs to remain a top priority at the agency. USAID plays a huge role not just in funding product development to combat global health challenges, but also ensuring that new technologies are appropriate for the communities where they will be used. Some of the tools that have benefited from USAID funding and expertise include the RTS,S malaria vaccine candidate, the groundbreaking CAPRISA microbicide trials, and the Xpert TB diagnostic. USAID also works in partnership with many critical players in the global health R&D space, such as other US agencies, the private sector, nongovernmental organizations, and universities. It’s clear that USAID has seen major successes in its support for global health R&D. As the House Appropriations Committee votes on the SFOPS bill on Thursday and the budget process continues, Congress will have to decide whether it should boldly support USAID’s goal of developing new health tools—tools that are projected to save millions of lives—or withdraw this support and risk halting scientific advancement in its tracks.