Anna Kovacevich

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.

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 US Food and Drug Administration (FDA) published guidance Tuesday outlining its standards for approving COVID-19 vaccines. According to the nonbinding guidelines, a vaccine candidate will need to be at least 50 percent more effective than a placebo to be fully approved—a benchmark often used for flu vaccine approval. FDA did not rule out potential for issuance of Emergency Use Authorizations, which would allow a vaccine to be temporarily approved based on relevant scientific evidence, before formal review of the candidate. In addition to the written guidelines, FDA Commissioner Stephen Hahn testified in front of the Senate Health, Education, Labor and Pensions Committee on Tuesday, reinforcing FDA’s commitment to a safe regulatory process and development of medical countermeasures to fight COVID-19.A COVID-19 vaccine developed by CanSino Biologics and the Beijing Institute of Biotechnology was approved for Chinese military use on June 25. The vaccine, Ad5-nCoV, was approved for phase 1 clinical trials in March and has since completed phase 1 and 2 trials. Clinical results showed safety and efficacy of the vaccine, according to CanSino. The recent approval, issued by China’s Central Military Commission, will last one year and is limited to military use. There are currently eight vaccine candidates in China approved for human trials at home and abroad, including Ad5-nCoV.Researchers at Columbia University and the University of Wisconsin-Madison recently identified five existing drugs that interfere with polymerase, a protein that helps SARS-CoV-2 spread throughout the body. Disrupting the polymerase reaction could help the immune system destroy SARS-CoV-2 and stop coronavirus infection. The five FDA-approved drugs include: ViiV’s Ziagen and Bristol Myers Squibb’s Zerit, both used to treat HIV; Roche’s Valcyte and Gilead’s Vistide, used for cytomegalovirus; and BMS’ Baraclude, used for hepatitis B. The researchers will perform cell-culture studies on these five antivirals to determine their efficacy against COVID-19, after which the most effective drugs could advance to further studies.