Research Roundup: FDA vaccine approval guidelines, COVID-19 vaccine approved for Chinese military, and potential repurposed antiviral treatment
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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.