April 11, 2014

IAVI CEO Margie McGlynn Submits Testimony to U.S. House Appropriations Subcommittee on State, Foreign Operations and Related Programs on Funding for AIDS Vaccine R&D

Written Testimony to the U.S. House Appropriations Subcommittee on State, Foreign Operations and Related Programs on the FY 2015 President’s Budget Request Submitted by Margaret G. McGlynn, President and CEO of IAVI.

Chairwoman Granger, Ranking Member Lowey and members of the Subcommittee, thank you for the opportunity to provide testimony on the President’s Budget request for Fiscal Year 2015. My name is Margaret McGlynn and I am President and CEO of the International AIDS Vaccine Initiative (IAVI), based in New York. IAVI is a not-for-profit, public-private product development partnership whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. The President’s Fiscal Year 2015 Budget request includes $28.7 million to maintain support for IAVI’s ongoing partnership with the U.S. Agency for International Development (USAID).

IAVI’s vision is a world without AIDS. We work with many partners to fulfill our deep commitment to advancing the science of AIDS prevention and bringing a vaccine closer to those who need it most. We are proud to partner with USAID in this endeavor, continuing the agency’s long tradition of fostering advances in science and technology to benefit the world’s neediest populations. Indeed, the new USAID mission statement is emblematic of this commitment. It is gratifying to see the agency’s emphasis on applying science and technology in the quest to end extreme poverty and build resilient, democratic societies. IAVI is privileged to serve as a partner in this work.

I would like to address three points in this statement: the urgent need for an AIDS vaccine, recent scientific progress in the field, and the value of the research capacity being strengthened in Africa as we advance toward an AIDS vaccine. First, please let me express, on behalf of IAVI and our many partners, my deep gratitude for the ongoing support of Congress in this endeavor.

The urgent need for an AIDS vaccine

More than 30 years after the virus was first identified, HIV/AIDS continues to devastate. More than 35 million people live with HIV worldwide. Last year 2.3 million people were newly infected with HIV and 1.6 million people died from AIDS-related causes, nearly two-thirds of them in sub-Saharan Africa. This scourge is not limited to the developing world: more than one million people in the United States are living with HIV, with the South bearing a disproportionate share (nearly half) of this disease burden. Fortunately, glimmers of hope emerge from among these grim statistics, thanks in large part to U.S. Government support through the PEPFAR program. Recent years have seen vast improvements in AIDS treatment and prevention, including wider access to antiretroviral therapy. New UNAIDS figures show that in just three years (2009-2012), the number of people accessing HIV treatment increased by 70 percent. The number of AIDS-related deaths fell by more than half a million between 2005 and 2012.

Yet the pandemic continues to outpace our ability to treat and prevent new infections. There are still 6,300 new infections every day; for every three people accessing treatment, four more become infected. And the most vulnerable continue to pay the highest price: 260,000 children in the developing world contracted HIV last year, and the prevalence among young women in Sub-Saharan Africa is more than double that among men. AIDS is the number-one killer of women of reproductive age in the world. The financial costs are significant, as well: nearly $19 billion was spent to fight HIV/AIDS in low- and middle-income countries in 2012, still at least $4 billion short of what is needed, based on UNAIDS projections.

Ending the HIV/AIDS pandemic demands a response that marries expansion of existing treatment and prevention programs with the development and swift rollout of new prevention technologies. Modeling data suggest that even if we achieve ambitious UNAIDS goals for scaling up currently available HIV/AIDS interventions in low- and middle-income countries, the end of AIDS cannot be achieved without a vaccine and other new prevention technologies. The PEPFAR Blueprint for an AIDS-free Generation specifically calls for continued development of microbicides and vaccines. A well implemented vaccination program with a vaccine that is 60% effective could reduce the number of new infections in developing countries by a quarter in the first decade after introduction, and almost half over the first 25 years. That’s up to 22 million potential infections averted.

The sooner we develop an effective AIDS vaccine, the sooner we can begin to avert the human and financial costs of future infections. Great progress has been made in the fight against AIDS, but it is clear that current tools are not enough to get us to the finish line.

Recent progress in the AIDS vaccine field

Several recent scientific breakthroughs have brought an effective vaccine within our reach. Results of a 2009 clinical trial in Thailand showed, for the first time, that a vaccine can help prevent HIV infection. Efforts are underway to better understand the factors that contributed to that protection. Moreover, over the last few years, IAVI and collaborators have made the breakthrough discovery of a series of naturally occurring broadly neutralizing antibodies that show us a pathway to developing a broadly effective AIDS vaccine. These discoveries were made possible through a collaboration between IAVI and U.S.-based biotech partners, illustrating the power of our partnerships with industry, academia, and scientific research organizations in the United States and around the world. IAVI is accelerating its broadly neutralizing antibody program on an aggressive timeline to translate the best ideas into clinical candidates, with the first vaccine candidates designed to elicit broadly neutralizing antibodies to HIV entering early product development and screening in humans, representing a significant milestone for the field.

The clinical pipeline also continues to progress. IAVI and our partners have translated groundbreaking technologies into 26 vaccine candidates, of which 15 have been tested in 27 early-stage human trials in 11 countries. This substantial scientific progress would not have been possible without the strong partnership of USAID and the steadfast support of Congress.

There have been challenges as well, including the early termination in 2013 of a large clinical trial, conducted by the NIH, evaluating whether a candidate vaccine regimen could prevent HIV infection or slow its progression to AIDS, after it became clear the regimen would fall short on both goals. This kind of setback, while disappointing, is to be expected in vaccine development. Vaccine researchers learn through informed trial and error what works, and what does not, and use that knowledge to hone their strategies and press ahead.

Strengthening clinical research capacity in Africa

While the path to an AIDS vaccine is long and complex, we are heartened by important progress along the way. Like our USAID partners, IAVI has a strong focus on sustainable research capacity in the developing world. Strengthening this capacity is central to IAVI’s mission, as it directly contributes to the science that will develop a vaccine, helps ensure that the vaccine ultimately matches the epidemic, and contributes to the infrastructure that will facilitate wide access to that vaccine once it is developed. We work with a network of clinical research centers in five of the most affected African countries, strengthening local scientific expertise and testing vaccine candidates in the places where they are needed most. IAVI sponsored the first HIV vaccine trials in Kenya, Zambia, Rwanda, and India, for example. Beyond equipping clinics and laboratories, IAVI also has overseen the training of more than 1,600 clinicians, nurses and counselors to ensure that they conduct their work in accordance with the highest scientific and ethical standards. I am proud to report that IAVI-supported clinical research centers have conducted 16 HIV vaccine and non-vaccine clinical trials in Africa to date.

Through our research efforts, we are also amplifying the efforts of PEPFAR and other implementers to provide HIV voluntary counseling and testing (VCT) in Africa. IAVI’s clinical partners on the continent provided free VCT to more than 47,000 individuals in 2012 alone; more than 300,000 individuals have gained access to VCT through IAVI-supported research since 2004. These are important markers of progress in support of the USAID development mission – strengthening health systems and sustainable research capacity, with a focus on building African leadership and ownership of HIV vaccine design and development, along the way to discovery of a vaccine.

Sustaining the commitment

There is great optimism in the AIDS vaccine field today. But this is tempered by the reality that vaccine development is hard – and HIV is a uniquely challenging target. I am grateful for the enormous support this Subcommittee has shown for IAVI’s partnership with USAID, whose commitment has also been essential to the quest for a vaccine. We are poised to capitalize on the promising discoveries of the past several years and advance candidates into clinical testing with the promise of ending this devastating epidemic. The investment we are making now will dramatically accelerate delivery of a vaccine to those who need it most, but the continued backing of Congress will be vital to ensure steady forward progress in the field. I urge you to support the President’s FY 2015 Budget request of $28.7 million for the IAVI-USAID partnership to ensure development of an AIDS vaccine. Your continued support will put us all an important step closer to a world without AIDS.