Breakthroughs Blog: Vaccines

In this guest post, Kari Stoever, vice president of External Affairs at Aeras, writes about how mine workers are disproportionately affected by tuberculosis (TB) and why there’s an urgent need for new tools against this deadly disease. Deep underground, in cramped quarters, with silica dust floating through the air, the hacking cough of a miner with TB is a familiar sound. Mine workers in sub-Saharan Africahave the highest rates of TB in the world, with wide spread consequences in communities throughout the region. It is estimated that mining is responsible for as much as 760,000 new cases of TB each year, making it the single biggest driver of the TB epidemic after HIV. Not only does TB contribute to the dangers of mine work, but it also decreases economic viability. Each year, the mining industry loses around $570 million in productivity costs, and miners lose $320 million per year in lost wages, due to TB. Photo credit: David Rockhkind/Aeras Fifteen South African nations, known as the Southern African Development Community (SADC), have pledged to confront the TB epidemic in the mines through investing in treatment and control programs. While these efforts are to be commended, the ultimate solution is to invest in new vaccines to prevent TB. Recently published study results in the New England Journal of Medicine found that when South African miners were given universal isoniazid preventive therapy—intended to prevent the progression of latent TB to active disease—there was no lasting effect on TB incidence among mineworkers. Because rates of TB are so high in this community, significantly reducing the spread of TB will only be possible with transformative new technologies to effectively halt transmission. What needs to happen for the mining industry to support research and development (R&D) for new TB vaccines? Governments must unlock resources for TB R&D. Health experts must educate policymakers about the need for new tools—such as vaccines, drugs, and diagnostics. Mining industry decision-makers must partner with research organizations to advance TB R&D to protect their workforce and to improve productivity and reduce operating costs. Supporting R&D for new tools to diagnose, treat, and prevent tuberculosis will be an integral part of making southern African mines safer. This week, Aeras is at Investing in African Mining Indaba, the world’s largest mining investment event, to discuss potential ways to partner with governments and mining industry officials to address the TB threat. View the slideshow and check out the info graphic to learn more about the deadly combination of tuberculosis and mining, and join us in spreading the word and advocating for new TB vaccines to protect mineworkers.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member the International Vaccine Institute and the Institute for Translational Vaccinology have agree to collaborate on vaccine research and development and to promote capacity building in low- and middle-income countries. The partnership will focus on improving available technologies, as well as regulatory processes. The House and Senate Committees on Appropriations have released a fiscal year (FY) 2014 omnibus appropriations bill . Funding for global health programs at the US Agency for International Development saw some increases, while the National Institutes of Health remains woefully underfunded—even with an increase of $1 billion over last year’s post-sequestration levels. Results of an early-stage clinical trial show that stem cells taken from patients’ own bone marrow could be used to treat multidrug-resistant and extensively drug-resistant tuberculosis (TB). More tests will be required before this treatment option is validated as a possible alternative to current TB drugs. New research from Washington University in St. Louis School of Medicine has found that a form of malaria attacks red blood cells by “clamping down on cells with a pair of proteins.” This finding may aid scientists in the design of better vaccines and drugs against malaria.

In this guest post, Kari Stoever—vice president of External Affairs at Aeras—writes about European support for new vaccines against tuberculosis (TB). TB is a disease most often associated with countries in the developing world, particularly in Asia and Africa. While India and China had the largest number of cases in 2012, Europe is not immune. Europe accounts for almost 18 percent of global cases of multidrug-resistant and extensively drug-resistant TB, with the highest burden in Eastern Europe. TB is estimated to cost the European Union around €6 billion (US$8 billion) each year. New vaccines to prevent TB will be the most cost-effective and long-term approach to saving lives and money, so it makes sense that Europe leads the world in the research and development (R&D) of TB vaccines. Europe is a major contributor to the development of vaccines globally, with as much as 75 percent of the global TB vaccine portfolio either originating in Europe or being developed in partnership with European public or private organizations. Of the five major donors contributing to TB vaccine R&D, three of them are European. Since 2000, the European Commission (EC) has invested more than €34 million (over US$46 million) in research for new TB vaccines. Along with European Union Member States, the EC has also invested more than €42 million towards clinical trial site preparedness, capacity building, and support in Africa through the European and Developing Countries Clinical Trials Partnership (EDCTP). Recently the EC announced a €25 million (approximately US$34 million) call for proposals to accelerate the development of new TB vaccines. Europe is a major contributor to the development of vaccines globally, with as much as 75 percent of the global TB vaccine portfolio either originating in Europe or being developed in partnership with European public or private organizations. Credit: PATH. The announcement comes as an important new collaboration between European funders and a global network of researchers is forming. The new initiative, the Global TB Vaccine Partnership (GTBVP), aims to channel finances to TB vaccine R&D to establish a robust and diversified global portfolio of clinical and preclinical candidates. One of the top priorities for the GTBVP will be to strengthen and diversify the preclinical and clinical portfolio to facilitate a more rational, cost-effective, and accelerated vaccine development process through the sharing of technical, financial, and market risks. The GTBVP’s role will be to foster greater alignment among researchers and funders’ objectives, and implement an effective mechanism for collaboration, information-sharing, and decision-making. Aeras, the Netherlands-based TuBerculosis Vaccine Initiative (TBVI), the EC, the European Investment Bank (EIB), the Bill & Melinda Gates Foundation, and the EDCTP are spearheading the development of the GTBVP. The evolution of the collaboration The push for a new financing mechanism and governance structure began in March 2012 when the EC, with support of the EIB, expanded its engagement with TBVI and Aeras to develop a Business Case for Investment. The document provides evidence of a viable market incentive for new TB vaccines, opening the door for more expensive later stage trials to be financed through cost-sharing arrangements with industry and the use of other risk-sharing financial instruments. Public sector grant funding for early stage research would act as a catalyst for this private sector investment, providing significant leverage to donors. By working with researchers around the world, it is envisioned that the GTBVP will play a crucial role in ensuring that research into life-saving TB vaccines continues to progress in the most efficient way possible. Europe’s leadership has been critical to the formation of the partnership, and the EC is to be commended for its excellent commitment to much-needed health interventions, especially a vaccine that would drastically reduce the number of TB cases. TB is a global threat requiring global action, and through the new partnership there is a historic opportunity for donors, disease-endemic countries, researchers, and other stakeholders to work together and achieve the goal of having new, more effective TB vaccines available globally.

“We cannot solve what we need to solve with existing interventions—we need science and technology,” said Gary Cohen, executive vice president at Becton, Dickinson and Company (BD), at an official side event at the 6th Session of the Opening Working Group on Sustainable Development Goals this week in New York City. The event—co-sponsored by GHTC, the International AIDS Vaccine Initiative (IAVI), and COHRED—aimed to ensure that a strong commitment to research and innovation for health is included in the post-2015 development framework. As the United Nations (UN) and Member States continue progress toward meeting the Millennium Development Goals, the goals’ 2015 expiration date is right around the corner, and the global community needs to come to consensus on what’s next. Earlier this year, a UN High Level Panel of Eminent Persons released a report outlining recommendations for the post-2015 development agenda, including twelve potential goal areas. The goal areas are a promising start, and a new GHTC position paper calls on the governments of the world to ensure that innovation is embedded as a key component of the post-2015 agenda. Ensuring that innovation is included in the post-2015 development agenda is necessary to maximize health impact for those most in need—namely populations in low- and middle-income countries. Products that are affordable, available, and accessible can contribute to more equitable health outcomes, ultimately ensuring that people are able to live healthy lives and reach their full potential. During the event this week, PATH President and CEO Steve Davis discussed the need for innovative ways to break the cycle of poor health and how PATH—a nonprofit product developer—is making a difference with some of its technologies. It is crucial that the patient is always the top priority in development of new tools. Davis noted that, “Innovation that doesn’t address the most vulnerable populations is not innovation.” From left to right: Steve Davis, PATH; Gary Cohen, BD; Kaitlin Christenson, GHTC; Margie McGlynn, IAVI; and Koki Muli, Kenyan Mission to the UN In order to fully address the need for new global health technologies, the post-2015 development framework must consider creating an enabling environment for health and development. Because of the lack of a commercial market for many products that address the health needs of low- and middle-income countries, for-profit pharmaceutical and biotechnology companies are sometime hesitant to take on the development of new tools on their own. Nonprofit product developers, including product development partnerships (PDPs), are able to address this gap by bringing together the public, philanthropic, and private sectors. Margie McGlynn, president and CEO of IAVI, noted at the event that partnerships like PDPs “are critical for delivering innovation and improving health in developing countries.” To achieve sustainable development, an increased number of good and decent jobs are essential. Science, technology, and innovation are key drivers in economic growth, the creation of new jobs—and ultimately—poverty reduction. Part of this economic growth comes from the private sector’s involvement in global health product development. Cohen of BD mentioned the many areas the private sector can contribute to the development of new technologies and economic growth, including: technology innovation, clinical testing, product development, manufacturing, regulatory processes, and global distribution. As the Open Working Group on Sustainable Development Goals and others continue to discuss what will be included in the post-2015 development agenda, the GHTC has four key recommendations for UN Member States that ensure the that the critical role of global health R&D is acknowledged. Specifically: Official development assistance, as well as domestic investments by low-and middle-income countries must prioritize support for the development of new global health technologies. All stakeholders involved in the development of new health tools must be accountable for ensuring timely and equitable access to new and effective technologies. Donors and national governments must prioritize scientific capacity building and strengthening local health innovation systems when investing in development programs. Donors and national governments must invest in building systems that promote and sustain innovation capacity in low- and middle-income countries to promote a truly enabling environment for achieving sustainable development goals. This includes investing in global R&D partnerships, improving health and regulatory systems, and creating national science, technology, and innovation policies. We’ve seen countless examples of how new technologies can make a difference in the health of vulnerable populations. “New technologies have contributed to saving millions of lives and billions of dollars,” Kaitlin Christenson, coalition director of the GHTC, said at the event. It now time to make sure that science, technology, and innovation have a clear place in what the final post-2015 development agenda looks like.