Research Roundup: NIH starts hydroxychloroquine clinical trial, clinical trial begins of second US COVID-19 vaccine, and anti-parasite drug may help treat coronavirus

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. Early data from two phase 3 clinical trials at the University of Chicago testing Gilead Sciences’ antiviral medicine remdesivir among COVID-19 patients is showing rapid recoveries in fever and respiratory symptoms among the patients. The university recruited 125 patients with COVID-19 to participate in these studies, of which 113 had severe cases of the disease. Researchers overseeing the trials reported nearly all patients were discharged from the hospital in less than one week after receiving daily infusions, noting only two patients have died. Although public health experts largely view these results as encouraging, clinical trials of remdesivir, including those with randomized control groups, are being run concurrently at other institutions to determine if this drug is safe and effective against COVID-19. Positive results from these trials could lead to fast approvals by the US Food and Drug Administration and other regulatory agencies in what could be the first approved treatment for the disease.Sanofi and GlaxoSmithKline (GSK) are joining forces to develop a vaccine for COVID-19. Sanofi will test its experimental coronavirus vaccine with GSK supplying some of the adjuvants—additional ingredients that improve efficacy and make it easier to produce vaccines in larger quantities. The companies plan to start human trials in the second half of this year, with the goal of having a vaccine available by the second half of 2021 if the studies are successful. If this partnership does produce a vaccine, GSK has also committed to reinvest any short-term profit from the vaccine into COVID-19 research and long-term pandemic preparedness. This partnership is one among many working to develop a COVID-19 vaccine. Earlier this year, Sanofi partnered with the Biomedical Advanced Research and Development Authority, a US agency focused on funding research and development for global health threats. In a statement, both companies pledged to make any vaccine that is developed affordable and accessible worldwide.Last week, President Trump announced he was halting US payments to the World Health Organization (WHO) pending a 60 to 90-day review. In his announcement, President Trump cited the organization’s failure to properly investigate early reports of the virus’ emergence and to stop its spread after it first appeared in China as reasons for halting payments. President Trump accused WHO of being China-centric and alleged the organization was critical of his administration’s travel ban from China as COVID-19 continued to spread globally. President Trump’s announcement has prompted international outcry with many noting now is not the time to end support for WHO. The US government contributed nearly US$900 million to WHO’s 2018–2019 budget, representing one-fifth of the agency’s operating budget for those years.

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. Last week, doctors in China reported that the malaria drug hydroxychloroquine helped to speed the recovery of a small number of patients who were mildly ill from COVID-19, the disease caused by the novel coronavirus. Symptoms such as cough, fever, and pneumonia went away faster, and the disease was less likely to become severe in people who received hydroxychloroquine than in a comparison control group that did not receive the drug. The study was small with just 62 individuals, limited to patients who were only mildly or moderately ill, and excluded patients with underlying conditions that could be made worse by hydroxychloroquine. The authors of the report noted hydroxychloroquine is a promising treatment for COVID-19 but that more research is required, including on how it works in treating the disease and how best to use it.The US government has made deals with Johnson & Johnson (J&J) and Moderna Inc—and is reportedly in talks with two other companies—to prepare them to mass produce coronavirus vaccines before one that is safe and effective has even become available. Last Monday, J&J announced a US$1 billion deal to create enough manufacturing capacity to produce more than one billion doses of a vaccine candidate that will not begin testing until September. This effort will be funded in part by the Biomedical Advanced Research and Development Authority (BARDA). Moderna, which has already begun human clinical trials of a vaccine candidate supported by the National Institutes of Health, also signed a deal with BARDA—an agency which ultimately plans to support five or six experimental vaccine candidates with the hopes of having two or three successful ones. There are currently no approved vaccines for COVID-19, and experts have estimated it could be 12 to 18 months before one receives regulatory approval.The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a new coronavirus test that takes only 15 minutes. The test from Abbott runs on its point-of-care ID NOW platform and weighs less than seven pounds, so it can be easily deployed to disease hotspots. This test is one of the fastest tests for COVID-19 available and comes just weeks after FDA EUA approval of a 45-minute rapid point-of-care test. Abbott plans to deliver 50,000 tests per day starting last week and plans to produce about five million tests per month. Public health experts say that a key factor in ending the spread of coronavirus is to dramatically increase testing. A lack of availability of COVID-19 test kits has been a point of contention in the United States, which now has the largest number of COVID-19 cases of any country in the world.