Breakthroughs Blog: Vaccines

We have many reasons to be thankful. Photo: Satya Murthy As global health advocates, our work often requires us to focus on unmet needs—such as the number of people worldwide who still die from preventable diseases each year, or the lack of adequate resources and investment to tackle these diseases. Yet with Thanksgiving just around the corner, there is much for which we, as global health advocates, can be grateful in terms of advancements achieved in the development and deployment of lifesaving global health technologies. In the spirit of the holiday, here is my list of ten global health advancements I’m thankful for this Thanksgiving: After years of slow progress in the development of drugs, vaccines, and diagnostic tools to fight Ebola, efforts are now moving at hyper speed. Several experimental treatments and vaccines are now being tested in clinical trials in Ebola-endemic countries. Thanks to the development and widespread implementation of effective vaccines, this year the world moved one step closer to the eradication of polio. Scientists from the US Centers for Disease Control and Prevention believe that the second of three forms of poliovirus has successfully been eradicated. The first vaccine against hookworm has been shown to be safe in early-stage clinical trials. An effective vaccine could protect the more than 600 million people infected with this dangerous parasite worldwide. Widespread access to and use of antiretroviral therapy (ART) is fueling incredible progress in the fight against HIV and AIDS. According to the UNAIDS 2014 report, 2013 saw the lowest level of new HIV infections this century and the lowest number of AIDS-related deaths since 2005. As of this summer, nearly 14 million people are accessing ART. The world could soon have an important new tool in the first against dengue fever. Results from the second Phase III trial of the first vaccine candidate against dengue fever showed the vaccine to decrease incidences of dengue fever by nearly 60 percent. Within a few years, women could have new, user-friendly options to protect themselves against HIV. Several new antimicrobial vaginal gels and antiretroviral-releasing contraceptive vaginal rings are currently undergoing clinical trials. Significant progress has been achieved this year towards the development of new tools to fight malaria. After receiving expedited regulatory approval from the US Food and Drug Administration last year, new malaria drug treatment candidate tafenoquine entered Phase III trials this year. Additionally, the malaria vaccine candidate RTS,S is now under regulatory review by the European Medicines Agency. New pediatric drug formulations to treat tuberculosis (TB) could be available as early as late next year, according to developers. This advancement is critical as there is currently no appropriately dosed, child-friendly TB treatment available. New vaccines, drugs, diagnostics, and other health innovations have led to 4.2 million fewer child deaths globally last year compared to 1990. There are 365 global health products in the research pipeline that have the potential to fuel incredible gains in health for people around the world. With so much accomplished in 2014 and so many promising tools on the cusp of development and delivery, we have much to be thankful for this Thanksgiving. This Thursday, enjoy your Turkey and fixings with family and friends and give thanks for the incredible progress we’ve achieved this year. And then next week, when our turkey hangovers pass, we’ll get back to work.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member PATH—along with the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Serum Institute of India (SII)—will receive a national award for this year’s most outstanding intellectual property licensing deal for the group’s technology transfer of the MenAfriVac™ vaccine—a low-cost meningitis vaccine specifically developed for people in sub-Saharan Africa. The 2014 Deal of Distinction Award—which recognizes excellence in licensing deals—will be presented to the group by the Licensing Executives Society at its annual meeting in early October. In a recent FDA Voice blog post, Food and Drug Administration (FDA) Commissioner Margaret Hamburg writes about FDA’s new strategic priorities. Given that the FDA continues to expand its global reach, and that nearly 40 percent of medicines Americans consume are developed outside the United States, the agency has established five strategic priorities: regulatory science, globalization, safety and quality, smart regulation, and stewardship. Policy Cures writes in their monthly update, RADAR, about recent news on global health research and development in Australia. Australia has committed AUD$30 million in annual funding to health research for development—including $10 million for product development partnerships. Five million dollars of funding could also be used for a health innovation fund (possibly a Grand Challenges Australia). As the Ebola outbreak in West Africa continues, the Center for Global Development looks at ways to find a cure for this deadly disease. They argue that two things are needed: cost-effective thresholds for investments in global health, and an Advance Market Commitment to accelerate the development of new vaccines for Ebola and other neglected diseases.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In a new paper—developed by the Council on Health Research for Development, GHTC, the International AIDS Vaccine Initiative, and PATH—the authors make the case for the inclusion of research and innovation for health as a central component of the post-2015 development agenda. The paper describes the impact that increased investments in R&D and innovation for health—particularly for the world’s poorest—have had in contributing to progress toward achieving the Millennium Development Goals (MDGs)—particularly for MDGs 4 (reduce child mortality), 5 (improve maternal health), and 6 (combat HIV and AIDS, malaria, and other diseases). In a recent special report from the Global Post, the prominence of public-private partnerships in global health is analyzed as governments laud private sector partners for their expertise and vast resources. However, while most believe public-private partnerships to be highly effective, the Global Post looks into how to quantify their impact given the lack of comprehensive and transparent metrics for evaluation. Last week we at the United Nations General Assembly, the US Agency for International Development, the UK Department for International Development, the Swedish International Development Cooperation Agency, the Australian Department for Foreign Affairs and Trade, and the Omidyar Network have launched a US$200 million Global Innovation Fund. Grants ranging from $50,000 to $15 million will be available for social enterprises, for-profit businesses, researchers, government agencies, and nonprofits. The Atlantic highlights a recent incident in El Paso, Texas, where a former hospital nursery employee tested positive for tuberculosis (TB), which caused panic and precautionary screenings of more than 700 infants who passed through the nursery over the last year. In addition to demonstrating that Americans are not immune to this diseases, the article also asks why an effective vaccine to prevent TB in the first place has yet to be discovered. The National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) have received national recognition for the “most outstanding intellectual property deal” for MenAfriVac™—a low-cost meningitis vaccine developed specifically for populations in sub-Saharan Africa. The vaccine—developed by GHTC member PATH and the Serum Institute of India—incorporated technology from the FDA, as well as a patent license for a manufacturing process granted by the NIH.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. As the world’s worst outbreak of Ebola continues to kill thousands of people in West Africa, pharmaceutical companies are beginning to focus their efforts of developing an effective vaccine that could prevent future outbreaks. Recently, both GlaxoSmithKline and Johnson & Johnson have announced plans to begin conducting human clinical trials for a vaccine. In a recent blog post in Breakthroughs, Deutsche Stiftung Weltbevoelkerung writes about the urgent need to improve the global health situation, and how they continue to advocate for health improvements in low- and middle-income countries. As part of this work, they have launched a series of policy briefs on the issue of global health research and development (R&D), outlining why we need to increase financial and political support (in Europe) for efforts aimed at creating new ways to tackle diseases such as HIV and AIDS, tuberculosis, and malaria. In a new article in PLOS, global health experts write on how the international community can fund global health R&D projects. After the World Health Assembly meeting last May, four demonstration projects were selected by Member States to apply new approaches to neglected disease research. Funding for these projects will come from a pooled international fund. A new paper takes a more detailed look into the pipeline for neglected diseases, finding 650 clinical studies for diseases primarily affecting populations in low- and middle-income countries. The study’s authors found that research centers and public organizations are the most important clinical trial sponsors (58.9 percent), followed by the pharmaceutical industry (24.1 percent), and foundations and nongovernmental organizations (9.3 percent). Thus far in 2014, the Food and Drug Administration (FDA) has approved the same amount of novel new medicines it did for the entire year in 2013. To date, the FDA has approved 27 novel new medicines—which includes biologics. If the agency continues at this rate, it may come close to matching the 39 novel new medicines approved in 2012.