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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. 

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.Seventy-five countries submitted expressions of interests to join the COVID-19 Vaccine Global Access (COVAX) Facility, a new initiative to ensure fair and equitable vaccine distribution around the world. The 75 interested countries would fund vaccine production and distribution through their national budgets, supporting vaccine access among their own populations as well as in 90 lower-income countries through voluntary donations. COVAX would provide a guaranteed share of vaccine doses to cover 20 percent of each country’s population and act as a supplement to any deals individual countries make with vaccine manufacturers. The COVAX Facility is a key part of the Access to COVID-19 Tools (ACT) Accelerator vaccine pillar, which is led by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (CEPI); and the World Health Organization (WHO). The initial goal of the initiative is to raise US$2 billion to buy COVID-19 vaccines, according to Gavi. More than 100 COVID-19 vaccine candidates are currently in development around the world.In an open letter to National Institutes of Health (NIH) Director Francis Collins, more than 100 scientists called for human challenge trials to accelerate the development of a COVID-19 vaccine. During challenge trials, healthy volunteers are given a vaccine and then exposed to a virus to evaluate whether the vaccine prevents infection. While challenge trials are controversial, they would hasten the COVID-19 vaccine development process, as conventional efficacy trials can take months longer. Signatories of the letter also noted that challenge trials are more likely to yield interpretable results. Some US lawmakers already support the idea, and WHO guidance has stated that human challenge trials are ethical when in compliance with certain criteria.The Foundation for Innovative Diagnostics (FIND)—a GHTC member—and Cepheid, Inc., announced last week the launch of a new rapid molecular tuberculosis (TB) test that can simultaneously detect first- and second-line drug resistance. The Xpert® MTB/XDR test can provide TB drug-resistance profiles in less than 90 minutes and could be crucial in the fight against extensively drug-resistant TB (XDR-TB), the most complicated form of TB. Current methods for identifying drug-resistance profiles for XDR-TB can take up to 16 weeks to give results. Diagnosis and treatment of drug-resistant TB has been an essential part of TB elimination efforts for years. FIND and Cepheid have both conducted evaluations on the new test, and the data will undergo WHO review later this year. 

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. On Monday, the US Food and Drug Administration (FDA) gave an Emergency Use Authorization (EUA) to a point-of-care COVID-19 antigen test developed by Becton, Dickinson and Company (BD), a GHTC member. The test—one of several COVID-19 diagnostics that BD has been working on—detects infection by scanning for proteins found on or inside the virus. The hand-held device provides results in about 15 minutes and runs on a BD diagnostics platform widely used across the United States. The relative speed of production and low cost of the rapid test make it an important tool in fighting the pandemic, according to FDA. BD has said it expects to produce 10 million tests by the end of September and 2 million tests a week thereafter.University of Oxford researchers are developing a rapid COVID-19 test that would cost less than US$25. The viral RNA test uses RT-LAMP technology and provides results from a throat or nasal swab within 30 to 45 minutes. The RT-LAMP technology requires no specialized equipment, scientific training, or a cold chain, which makes the device ideal for use in low- and middle-income countries that have less technical infrastructure. The test has gone through clinical validation, results of which researchers said would be published soon. Oxsed Limited, a new company launched by Oxford, will be pursuing its further development and market release.Newly released data demonstrates that an injectable form of cabotegravir is more effective than widely used oral drugs for the HIV prevention strategy of pre-exposure prophylaxis (PrEP). There are currently two FDA-approved PrEP drugs, both of which require daily oral intake. The new data, from trials conducted by the HIV Prevention Trials Network, shows that a single shot of cabotegravir every two months is 66% more effective than the most commonly used PrEP pill, Truvada. Viiv Healthcare, the company that developed the injectable drug, hopes to file for FDA approval in early 2021. The findings were presented by researchers during AIDS 2020, an annual international conference held virtually last week.