Breakthroughs Blog: WHO

At last week’s World Health Assembly, the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative launched the Global Antibiotic Research and Development (GARD) Partnership, an initiative to develop new antibiotics to combat the growing threat of antimicrobial resistance. More than EU€2 million has been pledged to the GARD Partnership, from nonprofit Médecins Sans Frontières and the governments of Germany, the Netherlands, South Africa, and the United Kingdom. This innovative financing approach will enable the partnership to delink the costs of research and development (R&D) from sales and product price; new treatments can be sold affordably and promoted responsibly, without the pressure to recoup the costs of R&D. During the incubation period, the partnership will finance three to four projects while developing a long-term business plan, with the goal of becoming an independent entity by the end of 2017. At a recent meeting of G7 finance ministers and central bank governors, World Bank President Jim Yong Kim announced the creation of an insurance fund to fight pandemics, which will provide up to US$500 million for pandemic response in the world’s poorest countries. The Pandemic Emergency Financing Facility will be funded by reinsurance markets and World Bank–issued catastrophe bonds, which have been used to respond to natural disasters. Premiums will be covered by the World Bank and development partners. Funding eligibility will be determined by the size, growth, and spread of an outbreak and will be limited to pandemics in 78 low-income countries, caused by certain virulent, infectious diseases, including influenza, SARS, MERS, Ebola, and other zoonotic diseases. The facility was established in collaboration with the WHO and insurance providers Swiss Re and Munich Re. The Japanese government has committed US$50 million to the facility. Researchers at the Icahn School of Medicine in New York have identified a protein on the Zika virus that inhibits the human immune system from effectively combatting the virus. The protein—NS5—blocks signals between Zika-infected cells and the immune system; consequently, the immune system fails to produce the potent antiviral interferon. NS5 plays a similar role in other flaviviruses, including dengue and West Nile, but the mechanism by which NS5 prevents interferon production varies. The study suggests that altering or removing NS5 would enable the immune system to swiftly attack the virus. The team believes that a vaccine against the virus could be developed using a live strain of Zika, weakened by modifying or removing NS5. Meanwhile, Australian biotechnology company Biotron announced last week the identification of two compounds in its library that are effective against Zika virus in test tubes. The company specializes in HIV and AIDS and hepatitis C treatments and uses a broad antiviral platform to target specific proteins known as vioporins that are also found in the Ebola, MERS, and Zika viruses.

A woman's hands holding a SILCS diaphragm. (Photo: PATH/Patrick McKern) Last week, GHTC member PATH launched the Caya® contoured diaphragm in the United States, after developing and testing nearly 200 prototypes to ensure the product was safe, effective, and user friendly. PATH collected input from women and health care providers across the globe throughout the research and development (R&D) process, ultimately creating an innovative contraceptive that protects against sexually transmitted infections, has no side effects, and is discreet, comfortable, easy to use, and “one-size fits-most." The Caya® diaphragm, which is now available in 25 countries, is an important addition to existing contraceptive options, as it is the first diaphragm introduced in the United States in 50 years. In 2014, the World Health Organization (WHO) recognized the Chinese Food and Drug Administration as a functioning regulator; China has now developed two vaccines—for Japanese encephalitis and influenza—that have received WHO prequalification, a sign that a product is safe and effective. A representative of the Bill & Melinda Gates Foundation, which has worked with the Chinese government to enhance its vaccine R&D capacity, said that the second prequalification “may be the start of China truly becoming a player in global health.” China recently established a system that regulates manufacturing for pharmaceutical products based on the European Medicines Agency’s (EMA) and US Food and Drug Administration’s (FDA) standards. However, China’s regulatory system still has some barriers to overcome, as the regulatory approval process takes much longer than the EMA’s or FDA’s. Additionally, the Chinese government requires vaccines and drugs to be packaged individually—which is not conducive to international shipping—and there are currently no guidelines on how a manufacturer can obtain a license in China if clinical trials are conducted abroad. A vaccine candidate for the Middle East Respiratory Syndrome (MERS) has been successfully tested in mice and will progress to Phase I clinical trials shortly. The vaccine uses a weakened strand of a poxvirus—known as Modified Vaccinia virus Ankara—that has been altered to display a certain protein unique to the MERS virus. The immune system recognizes the protein as foreign, and develops antibodies and T cells to combat MERS. In the lab, the MERS virus was not able to reproduce in vaccinated mice despite exposure to “high levels” of the virus. The vaccine was developed by the Ludwig Maximilian University of Munich’s Institute for Infectious Diseases and Zoonoses, and the German Center for Infection Research has already committed 1.5 million euros for the Phase I clinical trials. The results of a massive trial for a new pneumonia vaccine were announced last week, demonstrating a major reduction in cases of the disease responsible for fifteen percent of deaths in children under five years of age. The vaccine, known as PCV-10, protects against ten different bacteria that can cause pneumonia. The trial lasted seven years, during which time the vaccine was given to 35,000 children in the Kenyan town of Kilifi. Eighty percent of vaccinated children demonstrated greater resistance to pneumonia. The town saw a 42.7 percent reduction in cases overall, and a 95 to 100 percent reduction in invasive pneumococcal disease—the most deadly form of pneumonia.

The zoonotic Middle East Respiratory Syndrome (MERS), which World Health Organization (WHO) Director-General Dr. Margaret Chan called “a threat to the entire world” has spread to South Korea. More than 100 cases and 10 deaths have been reported, making it the largest outbreak outside of the Arabian Peninsula. While there are currently no vaccines or treatments for MERS, researchers are confident that with adequate political will and funding, such products could be rapidly advanced. Photo: PATH/Nguyen Ba Quang Dr. Matthew Frieman, a professor and researcher at the University of Maryland School of Medicine, has developed an experimental vaccine in partnership with vaccine company Novavax Inc. that successfully protected mice against the MERS virus. Greffex, another vaccine company, has already worked with the US National Institute of Allergy and Infectious Diseases to develop a vaccine that triggers the production of antibodies—proteins that protect against the disease—in mice. Dr. Frieman and Greffex CEO John Price agree that funding and political will are the only barriers to the development of a MERS vaccine. According to Price, Greffex could develop a MERS vaccine candidate in less than a month with a sample of the virus, but they lack the funding to conduct clinical trials. Researchers have also struggled to obtain the needed information and materials—including samples of the virus—from scientists in Saudi Arabia. In the meantime, Frieman is working to test existing, approved drugs for the treatment of MERS, and has identified 27 drugs that have demonstrated potential in combatting MERS in a laboratory setting. At this year’s G7 summit, leaders of seven countries—including Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States— pledged to advance research and development (R&D) for neglected tropical diseases and new antibiotics. The members of the G7 committed to supporting everything from basic research through the development of “easily usable and affordable drugs, vaccines and point-of-care [diagnostics].” The G7 Leaders' Declaration also endorses the WHO Global Action Plan on Antimicrobial Resistance and the WHO Global Observatory on Health Research and Development, highlighting the need for improved coordination of global health R&D. In a New York Times op-ed, Gregg Gonsalves and Mark Harrington, co-founders of the Treatment Action Group, reflected on lessons learned about the US Food and Drug Administration’s (FDA) drug approval process during the US HIV and AIDS epidemic. The article comes as Congress is considering the 21st Century Cures Act, a bill intended to advance medical breakthroughs, in part through FDA reform. The legislation includes several provisions to expedite the approval of drugs and medical devices based on what Gonsalves and Harrington consider to be “lower standards.” The authors assert that while innovative regulatory pathways—such as the Accelerated Approval Program—enabled early access to new HIV and AIDS drugs, pharmaceutical companies were still required to demonstrate the safety and efficacy of products before they entered the market. Additionally, in the case of preliminary approval, companies were expected to continue and complete clinical trials. To protect patient safety, Gonsalves and Harrington argue that such standards should be upheld, reminding Congress that those standards “paved the way for the development and approval of breakthrough drugs [that] have been proven to be effective and safe.” There are nearly 170 contraceptives products in the R&D pipeline, from discovery, through product development, to regulatory review. Researchers, advocates, funders, and procurement agencies can now find information about these products all in one place through Calliope, the Contraceptive Pipeline Database, a new resource developed by GHTC member FHI 360. Calliope includes information regarding the R&D stage, the partners, the active pharmaceutical ingredients, the delivery and duration, and the mechanism by which the technologies prevent pregnancy. The contraceptive pipeline is diverse, and includes vaccines, microbicides, implants intrauterine devices and balls, pills, and even microchips. The exchange was created to galvanize contraceptive R&D for low-resource settings through knowledge sharing and the facilitation of cross-sector partnerships.

Dr Margaret Chan, WHO director-general opens the assembly. Photo: WHO The 68th World Health Assembly (WHA) in Geneva wrapped up last week after addressing several items that will shape the next few years of global health innovation. While we’re very excited by the progress made, much hinges on the connections between this year’s assembly decisions, the finalization of the post-2015 Sustainable Development Goals (SDGs), and next year’s WHA, which will likely have an even greater focus on global health research and development (R&D). Here are some highlights from the last two weeks: First, there were several decisions that will impact the work of the entire global health community: WHO budget increase approved Member states approved WHO’s proposed program budget for 2016-17, increasing the biennial budget by US$236 million—a five percent increase from the previous cycle. The renewed push for malaria elimination through the Global Technical Strategy for Malaria was mentioned as one of the reasons behind the funding increase. Work on non-State actors’ engagement framework continues The Assembly also welcomed a report on progress of a draft framework for engagement with non-State actors—including nongovernmental organizations, private-sector entities, philanthropic foundations, and academic institutions—noting that it wishes to finalize the framework by the next WHA. Delegates requested that the director-general convene an intergovernmental meeting as soon as possible and submit a finalized draft for adoption at next year’s WHA, as well as submit a register of non-State actors. Delegates acknowledged the importance of WHO engaging with non-State actors, which may facilitate greater alliances between WHO and nonprofit product development organizations, as well as global health innovation advocacy groups. It was also a big week for global health innovation: Pooled R&D fund, CEWG recommendations progress WHO delegates consider draft resolutions. Photo: Pierre Albouy/WHO Member states officially noted a report outlining the role the WHO Special Programme for Research and Training in Tropical Diseases would play in hosting and managing a pooled R&D fund. The fund, which will be financed by voluntary contributions, is intended to support R&D for new technologies to meet the needs of low- and middle-income countries. Priorities areas for the fund will be identified by the WHO Global Health Research Observatory, which will be formally launched in January 2016. It remains to be seen how the structure of the observatory will ultimately be implemented, and how that will impact the work of the pooled fund. The pooled fund and observatory were developed as a result of recommendations from a 2012 report by the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) which was looking for ways to fund R&D for and achieve access to treatments and technologies for diseases predominantly impacting the poor. To demystify this conversation, GHTC and the Council on Health Research for Development cosponsored a live event and webinar at WHA that examined approaches to incentivizing global health R&D and ensuring access to technologies. The discussion featured panelists from PATH, Médecins Sans Frontières, Cipla, and the Norwegian Institute of Public Health. The webinar is available on demand here. Timeframe for global strategy on public health, innovation, and intellectual property extended Member states also agreed to extend the timeframe for action on The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA) from 2015 to 2022. The GSPA was adopted by members in 2008 “to promote new thinking on innovation and access to medicines.” The agreement also extends the timeframe of an overall program review of the global strategy on its achievement, remaining challenges, and recommendations on the way forward. A panel of experts to conduct the evaluation will not be established until early 2017, with their report to be presented at the 71st WHA in 2018. WHO endorses Global Vaccine Action plan which includes support for R&D During discussion around the Global Vaccine Action Plan (GVAP), member states approved a resolution that includes language directed at strengthening WHO’s prequalification program, which provides tentative evaluation of new vaccines and medicines. The resolution also included a call for increased capacity-building for R&D, technology transfer, and other elements of vaccine development. Ebola epidemic prompts creation of new emergency response capabilities, greater emphasis on development of new technologies As the Ebola outbreak in West Africa winds down, WHO’s efforts and preparedness for future health emergencies was a hot topic at the Assembly. Delegates welcomed WHO's commitment to make important changes in its emergency response work. Through an approved resolution, WHO will establish a new emergency response capability based on all-hazards preparedness with an emphasis on adaptability, flexibility, accountability, humanitarian principles, predictability, opportunity and country ownership. WHO also plans to establish a contingency fund of $100 million to finance emergency field operations for up to three months. R&D language was also included in the resolution, which supports the development of a ‘blueprint’ for accelerating R&D in epidemics or health emergencies where few or no technological solutions exist. WHO approves global malaria strategy which emphasizes importance of research and innovation Delegates showing support for the proceedings. Photo: WHO Member states approved the Global Technical Strategy for Malaria, which aims to eliminate malaria in at least 35 countries by 2030. The strategy emphasizes the importance of research and innovation, and the need for political commitment, sustainable financing, strong health systems, and collaboration across different sectors. Dr. Pedro Alonso, head of the Global Malaria Program, cited R&D as a necessary endeavor to reach the lofty elimination goals outlined in the strategy.WHO adopts global plan to combat antimicrobial resistance   A key item under discussion by governments was the draft WHO Global Action Plan on Antimicrobial Resistance (AMR) which was approve by member states. Angela Merkel, chancellor of Germany, opened the Assembly by calling AMR "an issue of crucial importance to humankind." Germany has made AMR a key priority during their current chairmanship of the G7. The plan calls for countries to put in place by 2017 systems to monitor drug resistance. It also calls for reductions in overuse of antibiotics and for more investment in new drugs and other health technologies. GHTC member RESULTS, along with the Stop TB Partnership and Global Health Advocates, highlighted the need for drug-resistant tuberculosis to be central to the AMR Global Action Plan throughout the Assembly, and the Global Health Council and Global Health Advocates France delivered a statement calling for drug-resistant TB to be central to the plan and included in the Communiqué of the G7 Summit.Role of Health in SDGs discussed As the finalization of the SDGs approaches this fall, the Assembly discussed the need to secure a strong role for health goals in the overarching framework, and adopted a resolution urging member states to emphasize, among other priorities, “medical products, vaccines and technologies.” Through the Global Health Council, GHTC presented a statement highlighting the need to include health innovation targets and indicators in the SDGs. Looking ahead to the 69th WHA: Several R&D topics to be revisited In comparison with last year’s WHA, this year’s agenda did not include as much substantive decision-making regarding global health R&D activities, such as the global health R&D observatory, the ongoing pilot demonstration projects, or the previously proposed R&D treaty. These topics will be revisited at the 69th WHA in 2016. Regulatory strengthening expected to be discussed We also expect that regulatory systems strengthening will be on the agenda in 2016, an area that is of interest to the US delegation in particular. Since the 2014 Ebola outbreak, interest has been revived in strengthening the involvement of stringent regulatory authorities, like the US Food and Drug Administration, in supporting quick review of emergency tools, as well as building capacity for regulation and increasing regulatory harmonization around the world. As you can see, it was a very busy few weeks! We’re pleased with the outcomes from the WHA, but also see a need to ensure that the important agreements and resolutions are carried forward by member state governments and partners. Hopefully with the upcoming final post-2015 discussions and the next WHO Executive Board meeting only six months away, we’ll see the momentum for global health R&D continue.