News

Statement from Jamie Bay Nishi, Director, Global Health Technologies Coalition (GHTC), on the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAI), signed into law today by President Trump, which reauthorizes the Biomedical Advanced Research and Development Authority (BARDA)This legislation is an important step forward in strengthening our nation’s preparedness against global disease threats. We applaud the Administration and Congress for recognizing that protecting our nation’s health requires deploying BARDA’s unique capabilities to combat all hazards—not only chemical, biological, radiological and nuclear threats, but naturally occurring health threats as well. The legislation’s authorization of Strategic Initiatives to develop countermeasures against emerging infectious diseases, pandemic influenza and antimicrobial-resistant pathogens is a welcome move in fortifying our nation’s public health defenses.Now, Congress must match this authorization with strong investments in BARDA so the agency can deliver innovations against the full spectrum of health threats we face. Most of BARDA’s work on emerging infectious diseases has been funded piecemeal through emergency appropriations for Zika and Ebola, funding now nearly depleted—even as the Ebola outbreak escalates. This funding by crisis approach is inadequate. It undermines our ability to prepare for future threats. The House of Representatives’ proposed fiscal year (FY) 2020 appropriation provides a modest increase for BARDA, which is welcome. But a larger investment is needed for BARDA to fully and equitably fund the breadth of disease threats within its mandate and capitalize on recent scientific advances to generate innovations that could dramatically boost our capacity to neutralize potentially catastrophic outbreaks.BARDA’s reinforced authority to pursue Strategic Initiatives against naturally occurring threats can provide a significant contribution to our nation’s defenses. But this authority is of limited value without sufficient funding. We urge Congress to provide BARDA with a budget that is aligned with its mandate—and its unique capacity to deliver new tools to fight back against intensifying threats like Ebola; unexpected emergencies like Zika; and smoldering problems, like the steady, ominous rise in drug-resistant infections, and the near certainty of a future fight against a deadly strain of pandemic influenza.  Diseases punish the unprepared. We need a research infrastructure primed for a rapid response. That requires a strong, reliable investment in BARDA distributed across a diverse and promising research portfolio.CONTACT: Katy Lenard, klenard@burness.com, +1 301-280-5719

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 large new study confirms previous research suggesting that a vaccine against rotavirus—a highly contagious virus that can cause severe illness and death in infants and young children— may have an added benefit: lowering the risk for Type 1 diabetes, an autoimmune disease that usually develops in childhood. The study showed a 33 percent reduction in the incidence of Type 1 diabetes among children who completed the three-dose RotaTeq series compared with unvaccinated children. RotaTeq, which protects against five different strains of rotavirus, is one of two orally administered rotavirus vaccines. Among those children in the study who took only one or two of the required three RotaTeq doses, there was no reduction in incidence compared with unvaccinated children. The reductions in risk in those who took the other version of the rotavirus vaccine, Rotarix, were not statistically significant. Approximately one million treatment courses of new child-friendly, easy-to-administer tuberculosis (TB) medicines have been ordered by 93 countries since they were first introduced in 2016, according to developer TB Alliance. Prior to the development of these treatments, caregivers would approximate children’s dosing by crushing or splitting bitter-flavored adult pills, which created adherence challenges. The new treatments meet World Health Organization (WHO) guidelines for childhood TB treatment and are dissolvable in water and flavored for palatability, making it easier for caregivers to administer. The 93 countries in which these treatments have been introduced account for 75 percent of the estimated global childhood TB burden. According to WHO, one million children are diagnosed with TB every year. US President Donald Trump recently issued an executive order calling for all US federal agencies to cut at least one-third of their advisory committees by September—a move many previous agency heads and critics say would weaken science-based regulation processes and the use of evidence-based policymaking. When excluding agencies that are mandated by law, a total of 462 boards and advisory committees that advise on government regulations and provide scientific oversight on other agency decisions are potentially on the chopping block as a result of the executive order. Critics of the executive order said that the one-third number put forth by the Trump administration seemed completely arbitrary and also pushed back on the notion that cutting the committees would save taxpayer dollars.

The Global Health Technologies Coalition (GHTC) has opened nominations for its 2019 Innovating for Impact Awards. Now in its third year, this initiative recognizes the research partnerships and political champions that help transform breakthrough scientific research into lifesaving drugs, diagnostics, vaccines, and other tools for devastating, unmet global health challenges.Awards will be presented in two categories:The PARTNERSHIP AWARD honors an innovative research and development (R&D) partnership that brings together multisector partners to advance a high-impact, game-changing global health technology. The partnership must have received federally funded research support or in-kind support from a US government agency.The CONGRESSIONAL CHAMPION AWARD honors two US Members of Congress whose actions have strengthened political will and advanced US efforts to develop technologies to fight the world’s most challenging diseases and health conditions.Nominations will be open until Wednesday, July 31, 2019. Awardees will be editorially selected by a committee of leaders from the global health and research communities. Honorees will be celebrated at a recognition dinner in Washington, DC in November before an audience of policymakers, US government officials, media, and leaders of the global health and medical research communities.Previous honorees for the Congressional Champion Award include Senator Roy Blunt (R-MO), Congresswoman Rosa DeLauro (D-CT), Senator Chris Coons (D-DE), and Congressman Tom Cole (R-OK). Past Partnership Award honorees include the respective partnerships that developed the dapivirine microbicide ring for HIV prevention and improved child-friendly tuberculosis medicines.

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 clinical trial in four African nations found no substantial difference in HIV risk among women using three different methods of contraception—an injectable, progestin-only contraceptive, a nonhormonal intrauterine device, or IUD, and a progestin-based implant. However, the study—conducted by a consortium led by FHI 360—revealed high rates of HIV contracted among each group of women studied, prompting calls for deeper integration of HIV prevention and family planning services. The World Health Organization (WHO) will begin synthesizing and sharing findings from the Evidence for Contraceptive Options and HIV Outcomes, or ECHO trial, with WHO’s Guideline Development Group, which will convene at the end of July 2019. This group will consider the trial’s results, along with other research, to determine whether changes are needed to the global guidance on contraceptive use and issue recommendations at the end of August. A study performed by researchers at the University of Oxford, along with partners at five other institutions, has identified the human antibodies that prevent the malaria parasite from entering blood cells—potentially key to creating a highly effective malaria vaccine. The study was done as part of a clinical trial in Oxford of the first vaccine candidate that targets the RH5 malaria protein, a protein contained in the parasite which must bind to a human protein on red blood cells in order to infect them. This study demonstrated which human antibodies effectively block RH5 from binding, thus preventing the parasite from spreading through the blood. Another key finding of the study is the discovery of a new antibody which slows down the speed with which RH5 binds to red blood cells, giving antibodies that do block RH5 from binding more time to act. Researchers aim to use these findings to develop an improved RH5 vaccine that induces more of the effective antibodies. A new civil society group, the Drug Transparency Observatory, has formed in France to monitor the French government’s implementation of a resolution on the transparency of medicines markets adopted at the World Health Assembly last month. A statement released by the new group calls on the French government and all countries to not only implement the adopted resolution, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing to include disclosure of research and development costs. The statement noted that the Drug Transparency Observatory will monitor “the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting.”