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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Drug-resistant germs sicken about three million people every year in the United States and kill about 35,000, representing a much larger public health threat than previously understood, according to an updated report released last Wednesday from the Centers for Disease Control and Prevention (CDC). The CDC previously estimated in a 2013 report that about two million antibiotic resistant infections occur every year, causing 23,000 deaths. Using previously unavailable data and by applying new methods, the CDC calculated that the 2013 estimate missed about half of the yearly cases and deaths caused by antibiotic resistant infections. Infectious disease experts say that the new numbers, though still conservative, underscore the magnitude of the problem and establish a new national baseline of infections and deaths that will help prioritize resources to address the most pressing threats. Health authorities in eastern Democratic Republic of the Congo (DRC) have introduced a new Ebola vaccine produced by Johnson & Johnson (J&J) in an effort to combat the world’s second-worst outbreak of the virus on record. The new vaccine—which has completed phase 1 and 2 clinical trials and has been endorsed by the World Health Organization (WHO) —will be administered to 50,000 people in the city of Goma, on the Rwandan border. The experimental vaccine, which requires two injections eight weeks apart, will be rolled out alongside Merck’s single-dose Ebola vaccine. Merck’s vaccine has been administered to over 250,000 people since the start of the current outbreak in August 2018 through a strategy known as ring vaccination, offering the vaccine to contacts of those likely to be infected. The J&J vaccine will be provided to “targeted at-risk populations” in areas where the virus is not yet being actively transmitted, according to WHO. The European Commission granted marketing authorization to Merck’s Ebola vaccine, known as Ervebo, last Monday, making it the world’s first approved Ebola vaccine. This authorization comes less than one month after the European Medicines Agency recommended it to be licensed. A few days following this approval, Merck also received WHO prequalification, a process in which WHO assesses vaccines and other medical products in order to assure member countries that they are safe and effective. Merck said it will also continue to work with the US Food and Drug Administration and regulatory agencies in African countries to license the vaccine. Ervebo is currently being used in the DRC under a “compassionate use” or research protocol similar to a clinical trial. Merck expects the licensed doses will become available during the third quarter of 2020 and has made a commitment to make the vaccine available to countries eligible for purchasing assistance through Gavi, the Vaccine Alliance, at the lowest possible price.

The Global Health Technologies Coalition (GHTC) yesterday honored Congresswoman Anna Eshoo (D-CA) and Congressman Mario Diaz-Balart (R-FL) for their leadership in supporting global health research and development (R&D) at its 2019 Innovating for Impact Awards, an initiative celebrating the US policymakers and partnerships driving global health innovation. GHTC also recognized the partnership that developed the RTS,S malaria vaccine—the world’s first malaria vaccine—for its efforts to advance this breakthrough technology. “I want you to know how much this means to me,” Congresswoman Eshoo said in accepting her award. “But I want to salute all of you….I draw from all of you and what you do….This genius of America will move us forward….When we succeed, when we discover, when we lead, we give hope to the entire world.” Congresswoman Eshoo, who chairs the House Energy and Commerce Health Subcommittee, was honored with a Congressional Champion Award for her instrumental role in establishing the Biomedical Advanced Research and Development Authority and for her efforts to strengthen the ecosystem in which the vital work of US health research agencies is carried out.  GHTC also recognized Congressman Diaz-Balart, who is a member of the House Appropriations Committee, with a Congressional Champion Award for his work to protect funding for global health programs and his sponsorship of the Global Health Innovation Act to support research programs at the US Agency for International Development. “Investments in global health R&D are so critical‒so critical‒to make the world not only a healthier place, but a safe place for all of us….The US leads the world in global health R&D…and it’s so important that we continue to support programs that are so essential to this field,” Congressman Diaz-Balart said in accepting his award.  GHTC presented the Partnership Award to Dr. Ashley Birkett, Director of the Malaria Vaccine Initiative at PATH, and Dr. W. Ripley Ballou, Vice President and Head of the US R&D Center, and Dr. Opokua Ofori-Anyinam, Director of Clinical Development, at GSK Vaccines, who accepted the award on behalf of the many partners who have supported the development of the RTS,S malaria vaccine. Developed through a unique product development partnership, led by GSK and PATH, with critical contributions from the US Department of Defense’s Walter Reed Army Institute of Research (WRAIR), other US agencies, and countless partners—and now in collaboration with the World Health Organization (WHO) —; RTS,S is the world’s first, and to date, only vaccine that has demonstrated it can reduce malaria in children. Over thirty years in the making, the vaccine is now undergoing pilot implementation in three sub-Saharan African countries and has the potential to substantially contribute to malaria control efforts and save tens of thousands of children’s lives. “On behalf of PATH and our partners, we are honored to receive this award and to have contributed to advancing this important new tool to save children’s lives,” said Dr. Birkett. “A vaccine for malaria is among many innovations needed to bring an end to this devastating disease, and we proudly stand with our partners in progressing towards a malaria-free world.” “This vaccine is the result of decades of dedication and collaboration between GSK scientists and our public and nonprofit partners to harness cutting-edge vaccine science to contribute to the fight against malaria,” said Dr. Ofori-Anyinam. “GSK is honored to be recognized alongside our partners as we continue our research to tackle one of the most pressing global health challenges.” Dr. Ofori-Anyinam was joined onstage by Yvette Collymore, Communications Manager for the Center for Vaccine Innovation and Access at PATH; Dr. Mary Hamel, Lead of the Malaria Vaccine Implementation Programme at WHO; and Colonel Viseth Ngauy, Director of the Malaria Vaccine Branch at WRAIR, for a dialogue discussing their organizations’ contributions to advancing the RTS,S vaccine. Attendees also heard from Dr. Carrie Wolinetz, Acting Chief of Staff and Associate Director for Science Policy at the National Institutes of Health (NIH), who delivered a keynote address on behalf of NIH Director Dr. Francis Collins who had an emergency conflict that prevented his attendance.  “GHTC is thrilled to honor Congresswoman Eshoo, Congressman Diaz-Balart, and the developers of the RTS,S malaria vaccine with our Innovating for Impact Awards,” said Jamie Bay Nishi, director of GHTC. “US leadership in global health R&D has helped fuel tremendous progress in generating new cures and vaccines to fight the world’s deadliest diseases, and we’re so delighted to recognize the outstanding work of our honorees who helped make this progress possible.” Global health R&D is vital to conquering the world’s greatest health challenges and to building a safer, healthier world for all. Now in its third year, the Innovating for Impact Awards celebrates US commitment to global health R&D and honors the multisector partnerships and policymakers helping to transform breakthrough scientific research into lifesaving technologies for unmet global health challenges. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.Scientists have identified a new strain of HIV for the first time in 19 years. This strain is part of the Group M version of the HIV-1 virus—the same family of subtypes responsible for the global HIV pandemic—and is the first new Group M HIV strain to be identified since the guidelines for classifying subtypes were established in 2000. Knowing which virus strains are circulating ensures that diagnostic tests used to detect the disease are effective and provides scientists with a more complete picture of how HIV evolves. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, noted there was no need for panic as current treatments for HIV are effective against this strain and others. According to the World Health Organization, approximately 36.7 million people in the world are living with HIV, and UNAIDS estimates that in 2016 1.8 million people became newly infected with the virus. Takeda Pharmaceuticals reported preliminary results from a late-stage study evaluating the effectiveness of its dengue vaccine candidate, which showed promising but mixed results. In the study which tested two doses of the vaccine in more than 19,000 children in eight countries, the vaccine demonstrated an overall effectiveness rate of 80.2 percent against all four strains of dengue virus. In one strain, known as DENV-2, the effectiveness rate was 97.7 percent but the effectiveness rates in two other strains, DENV-1 and DENV-3, were much lower at 73.7 percent and 62.6 percent respectively. There was not enough data to assess the effectiveness of the vaccine against the fourth strain of the virus. Experts note that before final safety and efficacy determinations can be made about the vaccine, longer term safety data is required, especially among children who were not previously infected with dengue virus—an issue that has hampered rival pharmaceutical company Sanofi’s Dengvaxia vaccine. In a pilot program in Zanzibar, an island off the coast of Tanzania, drones are being tested to deploy a new tool to help fight malaria. The drones will spray rice paddies, which are typical breeding grounds for malaria-transmitting mosquitoes, with Aquatain, a non-toxic, silicon-based liquid gel that creates a thin film on top of the water that traps and kills mosquito larvae and pupae by preventing them from breathing at the water surface. After the trial in Zanzibar, researchers plan to publish their findings in peer-reviewed journals and hope to expand their approach across the African continent. According to the United Nations, malaria kills a young child every minute and causes 75 percent of all deaths under the age of five.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. A new blood test for Zika that can detect the virus within a few hours has been approved for production and use by the Brazilian Health Regulatory Agency. The test can detect the virus in infected patients in less than four hours, a dramatically shorter turnaround time than current methods which can take anywhere from 15 to 30 days. This test is also highly accurate in people who have contracted other diseases transmitted by the Aedes aegyptis mosquito, whereas existing lab tests have challenges in differentiating between infections. The test will be produced by a Brazilian company, AdvaGen Biotech, and sold at no more than US$10 per test so that it’s available to most labs, according to the lead scientist who developed the tool. An experimental tuberculosis (TB) vaccine has shown nearly 50 percent protection against progression of active TB in clinical trials, researchers reported last week at the 50th Union World Congress on Lung Health in Hyderabad, India. These final findings from a phase 2b trial confirm earlier results first reported in 2018 for the vaccine M72/AS01E, developed by GlaxoSmithKline and the International AIDS Vaccine Initiative, and put the world one step closer to developing a better vaccine against the disease. Currently, the only available TB vaccine is the bacilli Calmette-Guerin vaccine. Developed in 1921, it is fairly effective for infants and young children, but its protection varies widely in adults. Researchers concluded that trial results support further evaluation of the vaccine as a tool for global TB control, including confirming results in larger, longer studies and broader populations. A Lassa fever vaccine candidate that could offer protection in a single injection was selected by the Coalition for Epidemic Preparedness Innovations to be advanced into human clinical trials by the end of the year. This vaccine, which is based on the measles vaccine platform, was the most effective single-injection vaccine candidate against Lassa fever evaluated by scientists at the Institut Pasteur and offered protection two days after immunization. Lassa fever is a hemorrhagic fever endemic to West Africa and infects up to 300,000 people per year, killing between 5,000 and 6,000.