Breakthroughs Blog: Research Roundup

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.

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.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.