News

On Monday, President Obama released his proposed budget for fiscal year 2017 (FY17). For global health advocates the budget was a mixed bag. GHTC was pleased to see many critical global health accounts receive proposed funding boosts, but there also worrisome cuts or flat-lined funding proposed in other important areas. New tools and technologies are critical for advancing global health, and robust funding for US global health accounts is key to bolstering US leadership in global health research and development (R&D). USAID and Department of State For the first time in several years, the President’s request for global health programs at the United States Agency for International Development (USAID) and the Department of State is higher than the level of funding enacted the previous year: the White House requested US$2.906 billion, which is $73.1 million (2.6 percent) higher than the $2.834 billion appropriated for global health programs at the two agencies in the fiscal year 2016 (FY16) Omnibus. This funding increase reflects sustained commitment to USAID’s global health goals—ending preventable maternal and child deaths, preventing infectious disease epidemics, and achieving an AIDS-free generation—all of which require emphasis on R&D. Specific programs proposed to receive increases include: $64.5 million increase for USAID’s maternal and child health programs, including a $40 million increase to Gavi, the Vaccine Alliance; $20.1 million increase for family planning and reproductive health; and a $71 million increase for malaria programs. These increases are critical to US engagement in global health R&D: New funding for the maternal and child health and family planning and reproductive health accounts will bolster USAID’s work to develop new innovations to help women and infants during pregnancy and childbirth, a strong component of the Saving Lives at Birth Grand Challenge. Increased contributions to Gavi to advance international efforts to deliver new and underused vaccines to children living in the world’s poorest countries. Increased funding for malaria—including the President’s Malaria Initiative—will accelerate US efforts to eradicate malaria through the development of new vaccines, drugs, diagnostics, and vector-control innovations. Despite these welcome increases, the President’s FY17 proposal cuts funding to several key accounts, including a $16.5 million cut for nutrition, $7.5 million for vulnerable children, and $13.5 million in cuts to neglected tropical disease (NTD) programs at USAID. The proposal also decreases funding for tuberculosis (TB) programs by $19.1 million, which comes in sharp contrast to the Administration’s National Action Plan for Combating Multidrug-Resistant Tuberculosis (MDR-TB), released in December 2015. These cuts could stifle promising work in global health R&D: Since 2014, the USAID NTD Program has been investing in R&D to ensure that promising new breakthrough medicines for filarial diseases can be rapidly evaluated, registered, and made available to patients. Limited funding could hamper these burgeoning efforts. The Administration’s MDR-TB Action Plan includes a strong research component. Limited funding for TB will hamper efforts to implement the plan and achieve its goals to accelerate R&D for new TB drugs, diagnostics, and vaccines to address the growing threat of drug resistance. Centers for Disease Control and Prevention Photo: CDC/Dr. Scott Smith Key accounts at the Centers for Disease Control and Prevention (CDC) received modest increases. The CDC Center for Global Health received a $15 million increase (3.5 percent) to $442.1 million, which bolstered funding for the Global Immunization ($224 million from $219 million) and Global Public Health Protection ($65.2 million from $55.2 million) programs. These accounts are critical for accelerating CDC’s role in developing and implementing novel vaccines and immunization programs, as well as for bolstering the agency’s role in capacity building for global health research and disease detection in partner countries. CDC’s Center for Emerging and Zoonotic Infectious Diseases (NCEZID) received a $49.6 million increase (8.6 percent), to $629.49 million. This increase will bolster NCEZID’s important work to develop new diagnostics, countermeasures, and innovative technologies for diseases like Ebola, rabies, and chikungunya. The additional funding will also help accelerate implementation of the National Strategy for Combatting Antibiotic-Resistant Bacteria. National Institutes of Health Funding for the National Institutes of Health—which conducts the bulk of the United States’ global health R&D—is also critical. For several key offices and institutes, the President’s FY17 budget proposes nearly flat funding: The National Institute of Allergy and Infectious Diseases (NIAID) received a $71.55 million increase (1.5 percent) to $4.7 billion. NIAID conducts vital R&D to accelerate the development of novel vaccines and other countermeasures to respond to public health emergencies—including the recent Ebola and Zika epidemics. The Office of AIDS Research (OAR) received level funding at $3.1 billion. Research conducted through OAR has been vital to the development of new tools and technologies to treat, diagnose, and prevent HIV and AIDS, and robust funding for research is critical to achieving an AIDS-free generation. Advancing global health requires a strong commitment to global health R&D. The President’s FY17 budget represents a promising start to advancing US leadership in global health innovation and is just the beginning of negotiations between Congress, US Agencies, and the Administration on final funding levels for FY17. GHTC will continue to monitor global health R&D accounts in the FY17 appropriations process and will support global health funding that facilitates sustained and robust investments in global health innovation. All $millions FY16 Omnibus FY17 President request FY17 President request v. FY16 enacted USAID Global Health Programs $2,834 $2,906.50 2.6% Tuberculosis $236 $191 -19.1% Malaria $674.00 $745 10.5% HIV and AIDS $330 $330 0.0% Maternal & Child Health $750 $814.50 8.6% Of which GAVI $235 $275 17.0% Nutrition $125 $108.50 -13.2% Neglected Tropical Diseases $100 $86.50 -13.5% Vulnerable Children $22 $14.50 -34.1% Global Health Security $72.50 $72.50 0.0% Family Planning & Reproductive Health $524 $544 3.8%     All $Millions FY16 Omnibus FY17 President request FY17 President request v. FY16 enacted CDC Global Health $427.12 $442.12 3.5% Global Immunization Program $219.00 $224.00 2.3% Of which Polio Program $169.00 $174.00 3.0% Of which Global Measles & others $50.00 $50.00 0.0% Global AIDS Program $128.40 $128.42 0.0% Parasitic Diseases and Malaria $24.50 $24.50 0.0% Global Public Health Protection $55.20 $65.20 18.1% CDC NCEZID $579.89 $629.49 8.6%     All $Millions FY16 Omnibus FY17 President request FY17 President request v. FY16 enacted NIAID $4,629.00 $4,700.55 1.5% Of which HIV and AIDS $1,400.05 Of which Biodefense & Emerging Infectious Diseases $1,370.35 Of which Infectious & Immunologic Diseases $1,081.69 Office of AIDS Research $3,100.06 $3,100.06 0% Of which Vaccines $553.91 Of which Therapeutics $645.29 Of which Microbicides $108.88

To bypass unreliable roads, a project funded by the Bill & Melinda Gates Foundation and the United Nations Population Fund is using drones to deliver contraceptives, condoms, and other health supplies to remote villages in sub-Saharan Africa. A drone operator, located in an urban area, loads the supplies into the machine and guides it to its destination, such as a rural health facility. After a successful pilot in Ghana, the project is expanding into six additional African nations, with several governments themselves offering to foot the bill, at just US$15 per flight. Researchers at Brigham Young University in Utah are developing a mobile vaccine kit, with the hope of making vaccine manufacturing as easy as making a Cup of Noodles. The kit is comprised of a one to three liter package and produces antigens—molecules that elicit an immune response, and can result in immunity against a certain pathogen. A health worker merely adds water and the kit generates a vaccine that can be used that same day. The kit is reusable and can be freeze-dried, and thus can be stored at temperatures up to 77 degrees Fahrenheit, which requires much less energy than storing traditional vaccines. The team has successfully used the kit to produce a cancer-fighting protein, and is currently testing its vaccine production capabilities. GHTC member IVCC is leading a $65 million initiative to expand access to new insecticides in 16 malaria-endemic African countries over four years, with the hope of protecting 50 million people from malaria. The project will focus on spraying indoor walls with insecticides, a practice that despite its efficacy against malaria, has decreased by 40 percent over the past few years as mosquitos have become resistant to older, affordable insecticides and as new insecticides remain expensive. IVCC will be partnering with UNITAID, who will help fund the cost of insecticides, as well as GHTC member PATH and the US President’s Malaria Initiative, among others. Insecticides are a critical tool in malaria control, and up to 80 percent of malaria cases prevented since 2000 are attributable to insecticides. However, if new insecticides are not developed and adopted, malaria deaths could increase by 120,000 annually. Photo: CDC/ Prof. Woodbridge Foster; Prof. Frank H. Collins Last week, the World Health Organization declared the Zika virus outbreak in Latin America a Public Health Emergency of International Concern, calling for expedited research and development for Zika vaccines and diagnostics. Currently, the most promising Zika virus vaccine candidates come from small biotech companies, including the Indian firm Bharat Biotech and Pennsylvania-based Inovio Pharmaceuticals. Bharat Biotech has two vaccine candidates against Zika, one that uses Zika and another comprised of a weakened version of the virus. The company launched its Zika program in November 2014, due to its similarity to dengue and chikungunya, which are endemic in India. The company is on the verge of animal studies, which will take approximately five months. Inovio is developing a DNA vaccine as well, an approach that is much faster but often less effective than using an inactivated version of the virus itself. Inovio is currently testing the vaccine in mice and plans to initiate testing in primates within “the next few weeks.” Meanwhile, Sanofi has initiated a Zika vaccine program, building on its experience developing a vaccine for the related dengue virus. Sanofi, the fourth largest pharmaceutical company worldwide, is joined by five more of the top ten—Pfizer, Merck & Co., Johnson & Johnson, GlaxoSmithKline, and Takeda—who are all currently evaluating their existing vaccine technologies and platforms.

WHO EB meets. Photo: GHTC/Jana Armstrong Over 1,000 attendees, a longer than ever agenda—with time management by a song for punishment and a chocolate Caramello Koala as a reward—the 138th World Health Organization (WHO) Executive Board (EB), chaired with humor and efficiency by Precious Matsoso, Director-General of the Department of Health, South Africa, concluded Saturday, January 30 after six days of discussion and debate. The main headlines were WHO emergency reform, WHO reform in general, the Zika response, transitioning from the Millennium Development Goals to the Sustainable Development Goals, universal healthcare, preparation for the United Nations (UN) High-Level Meeting on noncommunicable diseases, the upcoming UN General Assembly Special Session on the World Drug Problem, Framework for Engagement with Non-state Actors, Global Action Plan on Strategies for antimicrobial resistance (AMR), pandemic influenza preparedness, and promoting the health of migrants. The full agenda, associated documents and nongovernmental organization (NGO) statements can be found here. R&D featured prominently on the agenda The need for global health research and development (R&D) and access to global health technologies featured prominently in many of the agenda items addressed under Health Systems and Preparedness, Surveillance and Response including: 8.2: Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits 10.2: Comprehensive evaluation of the global strategy and plan of action on public health, innovation, and intellectual property: progress update 10.3: Follow-up to the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), Planning for an open-ended meeting of Members States to discuss progress 10.4: Substandard/spurious/falsely-labeled/falsified/counterfeit medical products 10.5: Addressing the global shortages of medicines and the safety and accessibilities of children’s medication R&D was also embedded as an important point within some of the key headline items including: 6.4: Public health dimension of the world drug problem including the context of the Special Session of the UN General Assembly on the World Drug Problem to be held in 2016 7.2: Health in the 2030 Agenda for Sustainable Development 8.1: Implementation of the International Health Regulations discussed with 9.1 2014 Ebola virus disease outbreak: follow-up to the Special session of the EB on the Ebola Emergency: section on information sharing on diagnostic, preventive and therapeutic products 8.5: Global Plan on antimicrobial resistance 9.2: Global health sector strategies: HIV, viral hepatitis, and sexually transmitted infections 9.3: Global vaccine action plan 9.4: Mycetoma The EB accepted all of these topics for inclusion in the 69th World Health Assembly (WHA) agenda. A number of NGOs, including GHTC, weighed in on R&D and access related topics discussed at the EB meeting. Full NGO statements delivered at the meeting are available here. Three resolutions related to health R&D introduced for WHA Most of the EB agenda consisted of “recognizing reports,” “providing guidance,” and “reviewing draft strategies,” however, the EB decided to put forward three resolutions for consideration at the WHA in May that have clauses related to R&D: Draft resolution on Health in the 2030 Agenda for Sustainable Development Draft resolution addressing the burden of mycetoma Draft resolution promoting the safety and accessibility of children's medicines Small steps taken on CEWG Agenda item 10.3, follow-up of the report of the CEWG, was particularly important for GHTC and other health R&D advocates. The EB discussed progress on the process and set the agenda for an open-ended meeting on the topic that will take place in March. This meeting is expected to result in a WHA resolution on possible WHO mechanisms for global health R&D priority setting, coordination, and a pooled fund for R&D. During the discussion, member states and observers made the following interventions: All member states supported the Global Observatory on Health Research and Development, a WHO platform created by the CEWG process to collate information on health R&D activities globally to identify gaps and opportunities and define priority areas for new R&D investments. Many statements expressed disappointment that funds received to support R&D (US$10 million) are dramatically lower than funding pledges ($85 million). Statements were made calling for the new pooled fund to incorporate support for R&D on antimicrobial resistance and emerging infectious diseases, though there was not consensus on this point. Several participants questioned how the CEWG process is coordinating with the UN Secretary-General’s (UNSG) High-Level Panel on Access to Medicines. The assembly seemed unified on non-state actors being allowed to attend the open-ended meeting, while holding open the possibility of a closed session on financing and coordination of next steps. Many participants argued for the need to de-link R&D costs from product price to increase affordable access. It was acknowledged that the fund should de-risk investment for low- and middle-income countries. Participants recognized a need to interface between work streams—observatory, priority setting and coordination, and the pooled fund. Feedback was given on the demonstration projects chosen and not chosen. P. Sharma of India was nominated by consensus as the chair of the open-ended meeting. The following NGOs made statements on this agenda point: GHTC (delivered through Global Health Council) Drugs for Neglected Diseases initiative Médecins Sans Frontières International Medicines for Malaria Venture Medicus Mundi International Organization for Cooperation in Health Care GHTC’s statement requested that global health R&D NGOs be permitted to participate in the March open-ended meeting since product development partnerships and public-private partnerships are responsible for 58 percent of the product candidates currently in the pipeline. The decision was ultimately made to include civil society. In wrapping up this agenda item discussion, Marie-Paule Kieny, WHO Assistant Director-General of Health Systems and Innovation, thanked Member States for their constructive requests and described this process as a marathon, not a sprint. She also highlighted the financial gap facing the current demonstration projects. Regarding the agenda of the open-ended meeting, she said that comments would be taken into consideration and proposed the following revised agenda: Day 1: Progress on strategic work plan and report from the UNSG High-Level Panel on Access to Medicines. Day 2: Presentations of work relevant to the CEWG: neglected tropical diseases; the global action plan for AMR; R&D Blueprint for action to prevent health epidemics; World Intellectual Property Organization (WIPO) research; and trilateral cooperation between WHO, the World Trade Organization, and WIPO on health, innovation, and access. Member state and Non-State actor statements. Day 3: Financing and Coordination. Looking forward, the 69th WHA agenda will very closely resemble the agenda of this 138th EB since the main point of the January EB meeting is to set the agenda for the WHA. Therefore, it will include important R&D topics including outcomes from the March open-ended meeting, the resolution votes, and the strategic plans discussed at this EB.

Euvichol® produced by EuBiologics. Photo: IVI In January, GHTC member International Vaccine Institute (IVI) announced that a new oral cholera vaccine it developed in partnership with Korean biotech company EuBiologics, Co. Ltd.—Euvichol®—received prequalification from the World Health Organization (WHO), paving the way for the vaccine to be purchased by global procurement bodies like Gavi, the Vaccine Alliance and UNICEF. GHTC’s Breakthrough blog is joined by Jerome Kim, IVI’s Director General, to learn more about this exciting development which will ease global supply limitations of the oral cholera vaccine and expand affordable access in countries where the disease is endemic. Tell us why this breakthrough is so critical. Cholera is a potentially fatal diarrheal diseases that affects between 1.4 million and 4.3 million people each year and causes as many as 142,000 deaths annually in low-income countries. Cholera is endemic in more than 50 countries, with outbreaks often occurring during humanitarian or natural disasters. Oral vaccines against cholera have existed since the 1990s as a potential tool to stem outbreaks. However, because the disease primarily affects poor communities there wasn’t a stable market to create demand for vaccine production at an affordable cost for these countries. To create a stable market for the vaccine, WHO created an oral cholera vaccine stockpile in 2013 to make the vaccine available at an affordable price for vaccinations in epidemic situations and endemic countries. In recent years, increasing demand for the vaccine created supply pressures on the stockpile and limited more extensive implementation of the vaccine. The prequalification of Euvichol® by WHO means a third oral cholera vaccine producer has entered the market. This will significantly increase the number of oral cholera vaccines doses available worldwide and address global shortages. Euvichol® is also expected to help bring down costs and expand access. How did the vaccine come to be developed and prequalified? The prequalification of Euvichol® is the culmination of a five-year long partnership between IVI and Eubiologics, a Korean biotech company. IVI worked with partners in Vietnam, Sweden, India, and the United States to develop a reformulated oral cholera vaccine to meet the needs of low-income countries. IVI originally transferred the technology to an Indian biotechnology company Shantha Biotechnics. Shantha licensed the vaccine in India under the name Shanchol™ in 2009 and received WHO prequalification for the product in 2011. To strengthen the cholera vaccine market further, in 2010, IVI transferred the technology for the vaccine to Eubiologics, as a second producer and manufacturer. Eubiologics advanced the product through clinical trials, receiving licensure from the Korean Ministry of Food and Safety in January 2015. This paved the way for the product to receive WHO prequalification in December, 2015. The development of Euvichol® was supported by the Bill & Melinda Gates Foundation, the Republic of Korea, and Sweden. The Global Health Investment Fund (an impact investment fund sponsored by the Gates Foundation and other partners), Korea-Seoul Life Science Fund, Korea Investment Global Frontier Fund, and Green Cross Corporation also provided funding to Eubiologics. The creation of Euvichol® is a great example of how the contributions of public, nonprofit, and commercial partners can be leveraged to advance technology development for diseases impacting the poor. What’s next for the vaccine? EuBiologics has initiated production of 6 million doses of the vaccine for 2016, which is expected to double WHO’s stockpile. IVI will continue to work with the WHO and partners to promote uptake of the vaccine and make sure it is available and used in places where it is needed most.