Breakthroughs Blog: Vaccines

“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.

In this guest post, Elisabeth Wilhelm, senior media specialist at the International AIDS Vaccine Initiative (IAVI), writes about the need to invest in the next generation of researchers and scientists in sub-Saharan Africa. Young people in countries suffering most from the AIDS epidemic want to have their say in development decisions to fight the disease. That’s what Sydney Hushie from the Global Youth Coalition on HIV and AIDS and fellow youth panelists stressed repeatedly during a United Nations’ General Assembly side event at the end of September in New York. And discussions at this year’s AIDS Vaccine Conference in Barcelona reinforced the insight that it will be the young scientists of today who will drive the innovation toward vaccines—among other new prevention technologies—that will help get to zero new HIV infections tomorrow. Access to quality education not only can help prepare tomorrow’s HIV and AIDS scientists—it can also help them beat the odds of becoming tomorrow’s patients. Nearly half of all new HIV infections globally occur in young adults of 15 to 24. The more education, the lower is the risk that young people will contract HIV. They want to learn: In a study in Zimbabwe, home to the world’s seventh-highest HIV prevalence, boys and girls were very interested in health-related issues such as HIV and sex. It will be the young scientists of today who will drive the innovation toward vaccines—among other new prevention technologies—that will help get to zero new HIV infections tomorrow. Photo: IAVI/Sokomoto The opportunities for young people to take an active role in this global fight remain as limited as their access to health care and to secondary education—as well as their countries’ investments in science, technology, and math (STEM), especially in sub-Saharan Africa. Tanzania and Kenya have the lowest post-secondary education rankings among 61 countries. Ghanaian students’ performance in the Trends International Mathematics and Science Study, for example, ranked second-to-last out of 45 countries surveyed in 2003. South Africa was ranked last by the World Economic Forum in quality of math and science education out of 62 countries. For those students in sub-Saharan Africa who beat the odds of completing a secondary education, many end up working or studying somewhere else—and the developing world can ill afford this “brain drain.” The World Economic Forum ranked 62 countries by their post-secondary graduation rates—Kenya came in 41st and Tanzania 50th. Their departures aren’t surprising. The World Bank estimated that skilled workers account for only 4 percent of the total workforce in sub-Saharan Africa, but 40 percent of those who leave their home countries. Scientists pick up and leave, too; indexes of published peer-reviewed articles show sub-Saharan Africa’s contribution to world science production hovers below 1 percent of total global output. IAVI and partners, such as the Kenya Vaccine Initiative and the Uganda Virus Research Institute, collaborate to help establish research centers and implement training programs and encourage the adoption of Good Clinical Practice. In Rwanda, the First Lady partnered with us to train young scientists in vaccine research, and across sub-Saharan Africa, we support fellowships that help local labs, local clinicians, and scientists become experts in their fields. Their vital research propels us closer to finding an AIDS vaccine. These scientists, together with the members of communities, offer guidance on designing clinical studies and developing vaccines that meet local needs. They also help ensure supportive local policies and sustained local funding—because we’re in it for the long haul, too. IAVI and partners, such as the Kenya Vaccine Initiative and the Uganda Virus Research Institute, collaborate to help establish research centers and implement training programs and encourage the adoption of Good Clinical Practice. Photo: IAVI/Courbet Other organizations are also paying attention to young scientists and advocates, whom they see as an investment in the future. The Global HIV Vaccine Enterprise has taken the lead in engaging and connecting Young and Early Career Investigators at scientific conferences, and other product development partnerships and research organizations, such as the European & Developing Countries Clinical Trials Partnership have made expanding young scientists’ research opportunities a priority. AVAC, a global advocacy prevention group, also builds an advocacy network to build in-country support for youth AIDS advocates. We cannot succeed in overcoming the challenges to developing a vaccine without our many partners, representing the best homegrown talent in sub-Saharan Africa and India. But we look to the next generation to help finish the job. Local perspectives will spur local innovations and foster new approaches to work in the lab and in the field. We can help by promoting more in-country innovation, supporting robust STEM education, and engaging young people earlier in academic settings throughout the Global South. The next generation of AIDS researchers could successfully bring one of human history’s most devastating and long-lasting pandemics to a close. Let’s give them a boost.

In this guest post, Dr. John Boslego, director of PATH’s Vaccine Development Global Program, writes about an innovative partnership between the United States and India to develop an oral vaccine against rotavirus diarrhea. I recently had the pleasure of attending an international symposium on rotavirus vaccines where the government of India’s Department of Biotechnology (DBT) and the Indian vaccine manufacturer Bharat Biotech announced positive results from a Phase III clinical trial of an oral rotavirus vaccine that was developed and manufactured in India. Data from the trial showed the vaccine, ROTAVAC®, to be safe and effective in protecting infants against severe rotavirus diarrhea, the most lethal cause of childhood diarrhea. ROTAVAC® represents an important scientific breakthrough against severe rotavirus diarrhea, responsible for approximately 100,000 deaths of small children in India each year. Credit: PATH. However, what’s most extraordinary about this announcement actually may not be the results themselves, but the long and unique road that ROTAVAC® traveled to reach this point. This vaccine is the product of an innovative partnership between the United States and India, involving renowned experts from a range of agencies and sectors across the two countries. The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in the mid-1980s. Since then, partners in the vaccine’s development have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and PATH. Each group has provided its own contribution to the project, ranging from technical assistance on vaccine development and manufacturing the vaccine batches used in clinical trials, to guidance on designing and implementing clinical trials that meet international standards. With the development costs shared by several partners, Bharat Biotech was able to commit to a price of US$1.00 per dose for ROTAVAC®. As such, Bharat Biotech plans to register the vaccine for use in India first. If licensed by the Indian regulatory authority, the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market. This represents an important scientific breakthrough against severe rotavirus diarrhea, responsible for approximately 100,000 deaths of small children in India each year. If licensed, this vaccine could save the lives of thousands of children each year in the country. Bharat Biotech also plans to submit ROTAVAC® for prequalification by the World Health Organization, so it may be procured for subsidized use in the developing world, giving it the potential to have an enormous impact on global public health by reducing rotavirus-related illness and deaths worldwide. I’m proud of the role that PATH has played in reaching this incredible milestone, and I am particularly impressed with how this truly innovative approach to a vaccine development partnership has resulted in the production of a safe and efficacious new rotavirus vaccine, ROTAVAC®.

In this guest post, Dr. Claire Huang, a researcher with the Centers for Disease Control and Prevention’s (CDC) Division of Vector-Borne Diseases, describes a dengue vaccine candidate developed by her team. The vaccine is now being clinically evaluated in field trials. This is the final blog in a four-part series by experts from CDC’s National Center for Emerging and Zoonotic Infectious Diseases. Dengue, a painful and sometimes deadly viral disease transmitted by mosquitoes, threatens more than 2.5 billion people, or 40 percent of the world’s population. Dengue is endemic in at least 100 countries in Southeast Asia, the Pacific Islands, the Caribbean, Central America, South America, and parts of Africa. A recent report in the journal Nature estimated that there are 390 million dengue infections yearly; 96 million of those infections cause moderate to severe illness, and 294 million cause no or mild symptoms. Previous reports also suggested that 500,000 severe dengue hemorrhagic fever cases and 22,000 deaths occur annually, mostly among children. In 2013, the World Health Organization ranked dengue as the fastest spreading vector-borne viral disease. The mosquito vectors of the virus have adapted to living in urban areas, so changes in demographics favor transmission. Puerto Rico, for example, had one of its largest recorded epidemics in 2010, with more than 21,000 reported cases. Several years ago, Florida reported its first cases of locally acquired dengue in 75 years, and the Republic of the Marshall Islands currently is experiencing its first epidemic since 1989. New outbreaks in Angola and Kenya are also being investigated right now by our Division staff. As the world has become more accessible and travel becomes more frequent, the risk from dengue viruses has increased. Large numbers of travelers return from dengue-endemic areas to the United States each year, increasing the possibility of introducing the virus to those parts of this country where the mosquitoes capable of transmitting dengue virus still thrive. Claire Huang (center) and her team (L-R), Janae Stovall, Betty Luy, and Karen Boroughs, in their CDC laboratory in Fort Collins, Colorado. Credit: CDC. I was born and raised in Taiwan, and I saw first-hand how devastating the disease can be. In 1987, South Taiwan had a dengue outbreak. Now, dengue is a common infection, and dengue cases are reported every year. This is how I became interested in dengue research. Vaccination is the best way to protect against mosquito-borne diseases, and it has been my lifelong passion to create a vaccine that will protect people against the crippling illness I witnessed. Despite decades of effort by many scientists to develop a vaccine for dengue, no licensed vaccine is available. Dengue is caused by infection with any of four distinct but related dengue viruses, and a successful dengue vaccine must offer immunity against all four types of the virus. Infection with one type of the virus produces lifelong immunity—but only to that dengue type. Infection with another type of dengue virus increases the chance of developing life-threatening dengue hemorrhagic fever. Typically, an epidemic caused by one dengue virus type is followed a few years later by an epidemic caused by one of the other three types. In most dengue-endemic countries, most teenagers have already been exposed to multiple dengue viruses. My team in the Division of Vector-Borne Diseases in Fort Collins, Colo., has developed a tetravalent dengue vaccine candidate active against all four types of the virus that is now being clinically evaluated in the United States, Colombia, Puerto Rico, Thailand, and Singapore for safety and efficacy. The vaccine is showing promising results in these human clinical trials. The novel technology invented at CDC and used to create the vaccine has been awarded multiple US and international patents. My team has partnered with Inviragen, Inc., a Colorado-based vaccine company, to conduct collaborative research, development, and licensure agreements. Inviragen is manufacturing the vaccine, named DENVax, and is conducting clinical development and testing of the vaccine for human use. The goal is to provide a safe, effective, and affordable dengue vaccine to protect billions of people living in or traveling to dengue-endemic countries. As my team’s efforts to develop this potentially lifesaving vaccine demonstrate, more research in dengue is needed to fully understand the disease and develop effective strategies to prevent and control the disease.