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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. 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.

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 Department of Defense is providing US$71 million for increased production of Inovio Pharmaceutical’s Cellectra devices—small, hand-held tools that are used to deliver Inovio’s vaccine candidate, INO-4800, directly to the skin without the use of needles. The device works by using a small electrical pulse that enables the DNA-based virus to pass into the recipient’s skin. Cellectra operates on AA batteries, and it is designed to "function reliably in challenging environments and can be stockpiled in large quantities without maintenance.” The vaccine, INO-4800, is expected to remain effective for up to one year in room-temperature storage. These durable qualities could make this vaccine system effective for low-resource settings. Inovio expects to begin a phase 2/3 trial in July. On Wednesday, the University of Oxford launched the first clinical trial in Africa of a COVID-19 vaccine. The vaccine being evaluated, AZD1222, was invented at the University of Oxford and is being developed in partnership with AstraZeneca. The trial is being conducted in South Africa, which has 120,000 of the continent’s 340,000 total cases. It represents a key moment for a continent that has so far been elbowed out of the global competition for medical supplies during the pandemic. Africa Centers for Disease Control and Prevention Chief John Nkengasong said, “unless we act now, Africa is at risk of being left behind on the global vaccine.” Others noted that several African countries have clinical trial capacities to contribute to global research and development. The University of Oxford is also running trials of AZD1222 in Brazil and Britain.Remdesivir, the first drug to demonstrate a benefit for treating COVID-19, has so far been delivered intravenously but will now be evaluated in an inhalable form in clinical trials. The inhalable version will be delivered via a nebulizer, a tool commonly available in the United States. Scientists at Gilead, remdesivir’s sponsor, hope that the availability of nebulizers will make it easier to use remdesivir at earlier stages of infection, such as when a patient tests positive but is presymptomatic. While delivering remdesivir as an inhalant may help overcome some of the limitations of intravenous delivery, it may also present other issues. Some physicians are worried that using a nebulizer could enable the spread of viral particles, and at improper doses, remdesivir can be toxic.