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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. Pfizer and BioNTech filed on Friday for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for their COVID-19 vaccine candidate, after data indicated 95 percent efficacy of the vaccine in phase 3 trials. A first look at early phase 3 data had showed the mRNA-based vaccine was more than 90 percent effective at preventing COVID-19 infection; follow-up numbers released after the trial collected sufficient safety data then showed a 95 percent efficacy rate. The vaccine could receive authorization by the end of the year—allowing distribution to begin in 2020—depending on the speed of the review, according to the CEO of BioNTech. The vaccine developers expect to produce up to 50 million doses of the two-shot regimen in 2020 and up to 1.3 billion doses in 2021.New data from AstraZeneca and the University of Oxford’s phase 3 COVID-19 vaccine trial signaled that the candidate has an average efficacy of 70 percent, with a range of 62 to 90 percent in different dosing schemes. Late last week, AstraZeneca and Oxford released results from their phase 2 trial, which showed that the candidate was safe and produced a strong immune response in younger adults and older participants. The developers plan to file for emergency use from regulatory bodies in the United Kingdom and other countries and expect about 3 billion doses to be ready in 2021. The results from Oxford/AstraZeneca’s trial followed announcements by two US-based vaccine efforts—Pfizer/BioNTech and Moderna/National Institute of Allergy and Infectious Diseases—indicating more than 90 percent efficacy of their COVID-19 vaccine candidates in phase 3 trials.FDA has granted EUA to the first rapid COVID-19 diagnostic able to be performed entirely at home. The test, developed by Lucira Health, requires the user to self-conduct a nasal swab, which is then swirled in a vial of laboratory solution that plugs into a portable device. The rapid result—which is delivered within 30 minutes—is then displayed as a light, labeled positive or negative. Initial use of the single-use test kit will require a prescription, but the company has said it expects the test to be widely available by next spring at a cost of US$50. FDA has authorized emergency use of nearly 300 COVID-19 diagnostics to date, but this will be the first conducted entirely at home, which experts hope will allow quicker quarantining and contact-tracing to combat spread of the virus.

On November 19, the Global Health Technologies Coalition (GHTC) convened its first virtual Hill event of the COVID-19 pandemic, connecting a group of congressional staff with representatives from four organizations advancing COVID-19 innovations to meet global needs. Twelve staffers representing members serving on key committees participated in the virtual dialogue. GHTC hosted the conversation to continue educating allies on the Hill about the need for COVID-19 innovations designed for use in low-resource settings, and how the US Agency for International Development (USAID) could support that effort—if Congress appropriates sufficient emergency funding in the next COVID-19 relief bill. The organizations who participated have strong records of advancing innovations for health emergencies with USAID support and are poised to play an important role in the global response to COVID-19. The event began with a presentation by Dr. Rebecca Richards-Kortum, director of the Rice 360° Institute for Global Health, on the institute’s COVID-19 diagnostic tool. The simple-to-use, rapid point-of-care diagnostic offers results in 30 minutes or less, using a platform that is expected to cost less than US$5,000 per instrument and less than $2 per test. With USAID support, Rice is validating the test and plans to pursue emergency use authorization from the US Food and Drug Administration (FDA). The team hopes to scale the test quickly to countries in sub-Saharan Africa where they have research partners and infrastructure in order to make an impact in communities where trained laboratory personnel, basic hardware, and reagents are not readily available to support widespread testing using currently available COVID-19 diagnostics. Shift Labs' DripAssist device. Photo: Shift Labs Next, Dr. Beth Kolko, co-founder and CEO of Shift Labs gave an overview of its DripAssist IV device. This ingenious device, designed to be durable, portable, easy to assemble, and operable with minimal training, can help a clinician anywhere in the world give IV medication safely and effectively without the use of costly infusion pumps. DripAssist, which was developed with support from USAID through the Fighting Ebola and Saving Lives at Birth Grand Challenges, was widely used during the recent Ebola outbreak in the Democratic Republic of the Congo—and even more recently was deployed in health care facilities in the United States facing a shortage of infusion pumps to address a surge in COVID-19 patients. “Designing for global needs gives engineers like our team a set of constraints that requires them to be more inventive,” Dr. Kolko noted, “And on the back end, you end up with a device that is more widely deployable,” including right here at home. Dr. Devin Sok, senior director of antibody discovery and development at GHTC member IAVI, followed with a presentation on IAVI’s COVID-19 antibody research efforts and how emerging antibody therapies could be a key tool to defeat COVID-19 globally. IAVI is focused on developing COVID-19 monoclonal antibodies both to treat individuals just exposed to the virus to stop progression to the severe form of the disease and also to prevent infection in individuals who might be at risk of exposure, like a temporary vaccine. While antibody therapies are typically expensive, Dr. Sok referenced the example of a low-cost monoclonal antibody product already on the market for rabies and noted that IAVI is proactively taking several steps in developing its product to drive down costs and ensure that it will be accessible and deployable in low-resource settings worldwide, even though this might delay product introduction. “We were aware from the beginning that we were not going to be first to market, but the priority was to be first to access,” he said. OraSure Technologies' rapid HIV self-test. Photo: World Health OrganizationFinally, Dr. Stephen Tang, president and CEO of OraSure Technologies, shared more about his company’s progress on developing a rapid antigen self-test for COVID-19, a tool with potential to dramatically simplify and expand access to COVID-19 testing in the United States and globally. Described by Dr. Tang as a “lab on a swab,” the test uses a self-collected nasal sample and delivers easy-to-read results at point of care without the need for additional instruments or laboratory analysis. OraSure’s history of designing diagnostics for global health needs has positioned the company well to support global access to COVID-19 diagnostic tools. It created the first rapid oral HIV self-test prequalified by the World Health Organization and the first FDA-approved rapid diagnostic test for Ebola, and it is now leveraging the same lateral flow platform these tests are built on for its COVID-19 diagnostic. Subject to receipt of an emergency use authorization by FDA, OraSure’s rapid self-test for COVID-19—developed with funding from the Biomedical Advanced Research and Development Authority—could be deployed worldwide.  Reflecting on the lessons OraSure has drawn from its experience developing HIV diagnostics and what’s required to ramp up COVID-19 diagnostic testing to the massive scale the world requires, Dr. Tang emphasized several interrelated factors: instrument-free self-tests are ideal for countries with limited laboratory infrastructure; ease of use is key, particularly in countries with low literacy rates; experience counts when it comes to working with regulators, particularly during health emergencies; and the ability to scale manufacturing to meet demand is paramount for impact.  After the presentations, the congressional staff participants posed a range of thoughtful questions about the innovations as well as the innovators’ perspectives on what the United States can do support the global response to COVID-19—from how US military research capabilities can be leveraged to design COVID-19 products suited for austere settings, to how members of Congress who represent researchers and research institutions can better advocate for resources needed to support science, to the specific measures that must be taken to scale up COVID-19 diagnostic capacity in the United States and around the world. As we consider the challenges of delivering certain COVID-19 products—including the leading vaccine candidates—everywhere they are needed worldwide, GHTC will continue to connect policymakers and their teams with innovators working to design tools with global access in mind. We hope this dialogue creates the foundation for an enduring partnership between congressional champions for global health innovation and the researchers whose work is fueling progress against COVID-19 and other global health threats.

“We might be tired of COVID-19, but it is not tired of us.” With those words punctuating his opening remarks, World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus reminded World Health Assembly (WHA) participants that the ongoing pandemic continues to dominate both our lives and the agenda in multilateral fora. This year’s virtual assembly tried to continue to galvanize the global community around a coordinated response to the pandemic and reassert the importance of other key global health priorities. While this virtual assembly did not provide the same opportunities as years past to engage with stakeholders, GHTC tracked the proceedings and worked with partners to weigh in on key agenda items. Here are our top takeaways from this year’s forum:WHO and member states remain focused on pandemic response, health emergencies governanceWith the ongoing pandemic continuing to dominate the attention of the world, global coordination to address COVID-19 was a clear priority for WHO during the assembly. Delegates debated the challenges and gaps in the ongoing response efforts, as well as preparedness and response mechanisms for future health emergencies. The assembly also approved a resolution to bolster WHO’s work and strengthen countries’ preparedness capacities; while the resolution primarily focuses on health system strengthening, the International Health Regulations, and governance, it does include a provision that calls on member states “to facilitate investment in strong national research agendas and adequate infrastructures for research and development in support of new measures to counteract the impact of health emergencies, including non-pharmaceutical interventions.” The debate between member states over the resolution felt like a precursor for the more far-reaching reform proposals that may be in the offing next year, following the completion of multiple reviews over pandemic response that are now underway. Those reviews are looking at countries’ and WHO’s pandemic performance, WHO’s health emergencies program, and the International Health Regulations system itself. There appeared to be a slowly emerging political consensus shaping up around initiatives being advanced by both Germany and France to significantly strengthen the hand of WHO in terms of its emergencies powers to obtain data from member states and take action. Unfortunately, the proposals currently don’t formally integrate research and development (R&D) into their frameworks. WHO develops Immunization Agenda 2030  Member states expressed broad support during the assembly for the Immunization Agenda 2030, which outlines research and innovation as one of its seven strategic priorities, highlighting the need for “continued research into new and improved vaccines, technologies and vaccine manufacturing platforms, as well as innovations in immunization service delivery and program management.”Germany noted that the current strategy does not factor in the impact of COVID-19 on current immunization priorities and programs and that an additional evaluation to integrate pandemic response efforts will be necessary to adequately reflect the shifting landscape.WHO TB research and innovation strategy moves forwardThis year, WHO unveiled their new Global Strategy for Tuberculosis Research and Innovation, drawing on consultation with scientists, national tuberculosis (TB) program managers, and other officials from within and beyond ministries of health, including ministries of science and technology, representatives of civil society and affected communities, research funding institutions, and other TB research and innovation stakeholders. A resolution on this new strategy was passed by member states via silence procedure in the summer and formally adopted during the assembly.The strategy outlines four major areas for action: 1) creating an enabling environment for TB research and innovation; 2) increasing financial investments in TB research and innovation; 3) promoting and improving approaches to data sharing; and 4) promoting equitable access to the benefits of research and innovation. “This global strategy will guide member states and other relevant stakeholders in translating political commitments on TB research and innovation into concrete action backed by investment, as an integral part of efforts to end TB,” said Dr. Tereza Kasaeva, director of WHO’s Global TB Program. The WHO strategy also promotes the sharing of data arising from publicly funded research, with the ultimate goal of ensuring that the public benefits from public investments in science. The resolution also calls for WHO to provide technical and strategic assistance to member states, urges countries to strengthen efforts for TB research and innovation as a complement to broader cooperation to tackle antimicrobial resistance at all levels, and pushes for increased coordination across United Nations agencies and greater collaboration with the private sector.While the strategy is a welcome development, further investment for TB research must follow from member states. Global leaders must close the US$1.3 billion funding gap for TB R&D annually if the 2030 targets are to be achieved. WHA adopts new road map for neglected tropical diseasesWhile member states did not spend much time debating the topic, they did adopt a new road map on tackling neglected tropical diseases (NTDs) at the assembly. The NTD road map sets global targets and milestones to prevent, control, eliminate, and eradicate 20 NTD groups.One of the key components of the road map is a shift away from single-disease vertical programs to integrated approaches, which promote improved coordination and collaboration. Another distinct feature is to drive greater ownership by national and local governments, including communities. The overarching 2030 global targets include a 90 percent reduction in the number of people requiring treatment for NTDs and a call to eradicate dracunculiasis—also known as Guinea-worm disease—and the chronic skin disease yaws, which affects mainly children under 15 years old.Research and innovation will be a critical component to ensure that these targets are met, and several member states called for greater investment for new tools to combat these diseases.Civil society engagement with WHO remains limited Civil society engagement with WHO continues to be a challenging process, and after several disappointing meetings this year, this month’s assembly was no different. The often hectic and oblique communication, or lack thereof, on how civil society organizations (CSOs) could meaningfully participate in these meetings heading into the assembly was yet another sign that the trend line on productive collaboration between WHO and CSOs is heading in the wrong direction.CSOs were also prohibited from delivering statements on certain agenda items, and like member states, they were forced to consolidate a number of agenda items into a single statement as WHO pulled together several topics into one session, creating a disjointed dialogue in which not all issues received adequate airtime.Moving forward, WHO needs to provide new avenues for CSO input around these fora, whether through separate listening sessions, online consultations, or other mechanisms that allow civil society to bring its expertise to bear and provide technical feedback to various processes.This year’s assembly felt largely more ceremonial than substantive at times, given the lack of debate on many agenda items and WHO speeding through the list of topics. The pandemic will continue to be a major focus in 2021 for WHO and member states, but other health areas that have been neglected through underinvestment on the WHA73 agenda must also re-emerge as key priorities.