Research Roundup: Countries sign on to global vaccine initiative, scientists call for COVID-19 challenge trials, and a new TB test profiles drug resistance

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.

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.