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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. Moderna and Pfizer announced last week the launch of phase 3 clinical trials for their COVID-19 vaccine candidates, the first late-stage studies supported by Operation Warp Speed in the United States. Both vaccine candidates are mRNA-based, meant to induce an immune response by mimicking the virus. The 30,000-subject phase 3 trials—to be conducted in locations across the United States—will evaluate the safety and efficacy of the vaccines. Moderna, in partnership with the National Institute for Allergy and Infectious Diseases (NIAID), and Pfizer, in partnership with BioNTech, have said they hope to seek regulatory approval and start supplying vaccines by the end of the year.Sorrento Therapeutics has licensed a saliva-based rapid COVID-19 diagnostic test developed by a fertility lab at Columbia University. The test, COVI-TRACE, is single-step and contained within a small tube, requiring no laboratory equipment. It works by applying heat to saliva in the tube, inducing a reaction from enzymes and reagents to provide a result within 30 minutes. If positive, the enzymes and reagents will react to the presence of the virus’ RNA and turn the liquid from red to yellow. A preliminary, preprinted study produced a sensitivity level of 97 percent and a specificity level of 100 percent, indicating low rates of false negatives and false positives. Sorrento intends to pursue emergency use authorization from the US Food and Drug Administration (FDA) and scale up production of the test.As COVID-19 vaccine trials increasingly scale up, some advocate groups and individuals are pushing to ensure diverse representation in clinical research. Clinical diversity—the inclusion of diverse populations including racial and ethnic minorities, elderly people, and those with underlying medical conditions in clinical trials—helps ensure that research covers the different ways individuals might respond to drugs and therapies. When it comes to COVID-19, populations that have historically been underrepresented in clinical research are among the highest risk for infection and death. Data has shown that Black and Latino populations are three times more likely to be infected with COVID-19 than white people and twice as likely to die. Chronic kidney disease has been identified as one of the top risk factors for serious infection. Eight out of ten COVID-19 deaths reported in the United States have been of people ages 65 and older. Several vaccine developers have acknowledged the importance of representing high-risk communities in clinical trials, and recent FDA guidance “strongly encourages” the inclusion of diverse populations in clinical trials but does not mandate representation.

COVID-19 is an unprecedented global health crisis. Just as every sector is grappling with unforeseen challenges, global health advocacy has been continuously adapting to a policy environment in flux. As part of this community, the Global Health Technologies Coalition (GHTC) has been responding by:Reporting on the latest developments in COVID-19 research and development (R&D).Tracking COVID-19’s impacts on the R&D ecosystem.Sharing key US and multilateral policy updates with our members and partners.Developing and advancing specific policies that would drive creation of new tools for countering COVID-19 in low-resource settings, especially in low- and middle-income countries (LMICs).GHTC applauds many of the actions taken by lead US policymakers over the last several months. Congress has appropriated more than $10 billion for research to respond to COVID-19 through four emergency supplemental bills, and this funding is driving high-impact innovation at record speed. Yet many of the new products that result from this innovation will be ill-suited for low-resource settings, which often lack electricity, adequate hygiene, highly trained health care workers, laboratory networks, robust supply chains, and other attributes often taken for granted in well-resourced systems. For these settings, we need different innovations:Drugs that are easily transported and administered without the need for highly trained health workers.Rapid diagnostic tests that can deliver results at point of care without using complex laboratory equipment.Vaccines that are single dose, can be stored at room temperature, can be rapidly produced and distributed, and are easily administered (ideally through ingestion, a patch on the skin, or an electrical pulse rather than an injection). Medical devices, such as specially designed non-invasive ventilators, IV infusion monitors, and oxygen delivery devices, that require minimal technical expertise, have fewer and more easily replaceable parts, are quickly manufactured, and are battery operated.Personal protective equipment that is durable, reusable, open-source, and can be quickly manufactured and adapted in a variety of settings.Through our US and multilateral policy efforts, GHTC has been advocating for policies that would foster these needed products. In our US advocacy, we are pushing Congress for three funding lines that would drive innovation at the US Agency for International Development (USAID), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Centers for Disease Control and Prevention (CDC):$200 million for Global Health Programs at USAID to advance and deliver innovations to help LMICs prevent, prepare for, and respond to COVID-19 and other pandemic threats. These innovations should be specifically designed for low-resource settings and should include vaccines and vaccine delivery systems; diagnostics; therapeutics; medical devices; personal protective equipment for frontline health workers; health facility innovations; and the financing, manufacturing, and delivery systems these essential resources require.At least $200 million to CEPI to advance vaccine candidates for SARS-CoV-2. CEPI is advancing nine vaccine candidates and has put forward a $5 billion global ask to advance this portfolio. US support for CEPI will help ensure that vaccines developed will be deployed effectively and affordably worldwide.Robust funding for the CDC Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases to support the development and deployment of essential tools to combat COVID-19 globally.In our multilateral advocacy, GHTC has been pushing back against the United States’ retreat from international leadership on COVID-19 R&D, including the decision to withdraw from the World Health Organization (WHO) in the middle of the pandemic. GHTC advocates that the United States should work with other global leaders to proactively invest in global product development, manufacturing capacity, and product delivery mechanisms, including the Access to COVID-19 Tools (ACT) Accelerator, which could be instrumental in helping LMICs finance the purchase and administration of COVID-19 vaccines, treatments, diagnostics, and other tools. GHTC has also been pushing other G7 and G20 leaders to fill the funding gaps for the ACT Accelerator and to support other financing mechanisms such as a World Bank global health security challenge fund and health systems strengthening investments by regional development banks.GHTC is also engaging with the Global Health Security Agenda (GHSA) and pushing for the explicit inclusion within GHSA of R&D for diagnostics and medical countermeasures to respond to emerging health threats.Finally, GHTC has been working with other global stakeholders to assess how new COVID-19 product development and deployment mechanisms could be used to reshape the global R&D ecosystem and benefit other critical global health priorities.To support our US and multilateral policy asks, GHTC is tracking US government and multilateral-supported COVID-19 R&D, publishing materials to help policymakers and the public better understand these research efforts, and leading and supporting our partners with aligned messaging:GHTC COVID-19 R&D Tracker [Editor note: This was discontinued in 2021]COVID-19 Vaccine 101: The Facts that MatterGHTC maps the US agencies involved in Global Health Security R&DGHTC-led Congressional letter to support R&D for the international responseGHTC featured in Global Citizen: “To Defeat COVID-19, the United States Must Invest in Innovations for All”GHTC defends WHO’s role in global R&D response to COVID-19GHTC condemns US withdrawal from WHOGHTC endorses FIND’s Call to Action on COVID-19 testingThis is the first global health crisis in this century to significantly affect every person living in the United States and around the world—a catastrophe that could raise awareness and support for global health R&D. GHTC will continue to leverage this moment and emphasize the narrative that links all the issues we work on, that global health and global health security can never be assured until we have a robust, coordinated, and global R&D ecosystem that includes the populations, diseases, and conditions too often overlooked.

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. The European Medicines Agency (EMA) issued a positive opinion on the monthly dapivirine vaginal ring, developed by GHTC member the International Partnership for Microbicides (IPM), for use by cisgender women 18 and older in developing countries to reduce HIV risk. The ring—designed to help address women’s unmet need for HIV prevention methods—is the first long-acting HIV prevention product. The EMA opinion recommended the ring’s use in combination with safer sex practices when daily oral pre-exposure prophylaxis (PrEP) is not used or cannot be used. Efficacy data indicated the dapivirine ring reduced women’s HIV risk by 35 percent and showed no safety concerns with long-term use. This EMA decision paves the way for review by the World Health Organization (WHO) and regulatory bodies in each country where it is intended for use. IPM is continuing market and implementation research and working on rollout plans, with a hope for making the ring available in some communities with urgent need sometime in 2021.Three laboratories working on COVID-19 vaccines released promising results last week, reporting their findings from early human trials. The three vaccine candidates—developed by Oxford University/AstraZeneca, CanSino Biologics, and Pfizer/BioNTech—all produced strong immune responses with antibody levels similar to those seen in patients who have recovered from COVID-19. The developers also indicated that immunity is likely to require a second vaccine dose. Scientists have cautioned that lab results from these early vaccine trials do not guarantee COVID-19 disease prevention. Among outstanding questions is the long-term efficacy and effects of these candidates, as the trials have only measured results over a few weeks. The three developers that released results last week—along with Moderna, which reported its vaccine candidate’s positive immune response the week prior—will continue further human trials in the upcoming months.A study conducted by the UK-based company Synairgen reported positive results for a potential new COVID-19 treatment method: an inhaled form of interferon beta, a naturally occurring antiviral protein more commonly used in its injectable form to treat diseases like multiple sclerosis. Results from the study of 101 patients, not yet published in a peer-reviewed journal, showed that hospitalized patients who received the treatment had a 79 percent lower risk of developing more debilitating symptoms and were twice as likely to recover without limitations compared to those receiving a placebo. The preliminary double-blind placebo-controlled study will be followed up with larger clinical trials.

Statement from Jamie Bay Nishi, Director, Global Health Technologies Coalition (GHTC)Today, the European Medicines Agency (EMA) adopted a positive opinion under Article 58 for use of the monthly dapivirine ring by cisgender women ages 18 and older in developing countries—a move that we at the Global Health Technologies Coalition (GHTC) applaud as a major milestone for women’s HIV prevention efforts. We urgently need new and better technologies to tackle HIV/AIDS, which is the leading cause of death globally for women ages 15-44 and one of the biggest threats to women’s health and well-being. Today’s decision represents significant progress for a tool that has been shown to not only reduce women’s risk of HIV, but one that finally could offer them a discreet, women-centered option that they can use on their own terms.Today’s outcome is a testament to the critical role of US government investments in global health research and development (R&D). Developed by the nonprofit International Partnership for Microbicides (IPM), a GHTC member organization, the ring received crucial funding for nearly two decades from numerous donors, including the US Agency for International Development (USAID), in partnership with the US President’s Plan for Emergency AIDS Relief (PEPFAR), and in-kind support from the National Institutes of Health (NIH). These investments ensured late-stage clinical trials and ongoing follow-up studies, and, pending future regulatory approvals, will enable IPM to introduce the ring in countries in sub-Saharan Africa.With its potential to transform lives in sub-Saharan Africa, the ring illustrates yet another example of the impressive return on U.S. investments in global health R&D. Yet this is not the end game. Bringing this devastating epidemic under control will require an expanded toolbox of next-generation prevention and treatment products, such as long-acting injectable antiretroviral drugs, multipurpose prevention tools and vaccines. And most importantly, it will mean ongoing, sustained investments in the U.S. government agencies that have made these lifesaving innovations possible.