Breakthroughs Blog: COVID-19

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.

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.  Scientists studying the genetic code of the novel coronavirus have determined it is not mutating quickly, suggesting the virus is less likely to become more dangerous as it spreads. Although all viruses evolve over time, accumulating mutations as they replicate inside a host’s cells and spread through a population, scientists say there is no evidence that some strains of the new coronavirus are deadlier than others. Researchers at Johns Hopkins University are now studying more than 1,000 samples of the virus and have noted only four to ten genetic differences between the strains that have infected people in the United States and the original virus that spread in Wuhan. This represents hope for researchers working to create a long-lasting vaccine against the pathogen. Several vaccines are currently in development, but experts posit it could be at least a year to 18 months before one becomes available. The US Food and Drug Administration (FDA) has announced it is making it easier for doctors to try an experimental treatment for seriously ill COVID-19 patients that uses plasma from people who have had the disease and recovered. Though there is currently little evidence this treatment works in people infected with the novel coronavirus, the approach has recently been used with some effectiveness to treat patients with SARS and Ebola. The idea is that so-called convalescent plasma taken from donors recovering from infection will contain antibodies to the virus that can be used to treat other patients. There are risks with this approach, the worst being it could make the patient sicker—a response known as antibody-dependent enhancement where the virus is actually helped to proliferate by a patient's own immune system. The FDA will still require doctors to seek approval to use the treatment for individual patients, but they can receive authorization in less than four hours via phone call. The FDA has granted emergency use authorization for a rapid COVID-19 test on the GeneXpert platform, a widely used tool for tuberculosis diagnostic, which could facilitate increased testing capacity in low- and middle-income countries (LMICs). There are more than 23,000 of the devices worldwide, which are produced by Cepheid, including an estimated 7,000–10,000 across Africa, Latin America, and South-East Asia. The tool can process nose swab samples in only 45 minutes and perform up to 96 tests in 24 hours. GeneXpert tests are automated, point-of-care devices which allow healthcare facilities to perform the test in-house without having to send samples off to a lab, allowing for real-time management of patients being evaluated for admission to facilities. Advocates are calling on Cepheid to reduce the price of test cartridges from US$20 to $5 to make them more affordable in LMICs.

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. Due to overwhelming demand, Gilead Sciences has paused granting patients access to remdesivir, an experimental drug which up until now has been used under a “compassionate use” policy against COVID-19—the disease caused by the novel coronavirus. In a statement, the company said it is focused on processing previously approved requests and establishing a new system that allows patients to get the drug in a similar time frame to what it would have taken to work through the requests it has already received. The company will make exceptions for pregnant women and children under the age of 18, as well as those with confirmed cases of COVID-19 who are experiencing “severe manifestations” of the disease. Gilead noted that, in recent weeks, there has been an “exponential increase” in requests for compassionate use of remdesivir due to the spread of COVID-19 in the United States and Europe, which has flooded the treatment access system which was never intended for use in response to a pandemic. Remdesivir is currently being studied in five large clinical trials, two of which could yield results in early April. The World Health Organization (WHO) has announced it will launch a multi-arm, multi-country clinical trial, known as the SOLIDARITY trial, for potential coronavirus therapies. The trial will test four drugs or drug combinations already licensed and used for other illnesses as part of a global effort to identify treatments for COVID-19. The four therapies include the antiviral drug remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and the antimalarial drug chloroquine—all of which have shown some effectiveness against the novel coronavirus either in vitro and/or animal studies. These therapies will be compared to the standard of care—the regular support hospitals treating patients currently use, such as supplementary oxygen. Ten countries have already indicated they will take part in the trial. WHO launched a similar trial in the Democratic Republic of Congo in November 2018 to test four therapies against Ebola. Phase 2 and 3 clinical trials of Takeda’s tetravalent dengue vaccine candidate showed that it is safe, produces immunity in children, and protects against the disease—regardless of previous exposure to different strains of the virus—according to studies published in The Lancet. In the phase 3 trial, researchers found an overall vaccine effectiveness of 80.2 percent in the first 11 months and 73.3 percent in the first 17 months. Takeda’s dengue vaccine candidate is only the second dengue vaccine to enter clinical trials, following Sanofi Pasteur's Dengvaxia. Sanofi’s vaccine was 56–61 percent effective in preventing dengue in children, but it was tied to severe illness in some individuals vaccinated without having prior exposure to infection. Dengvaxia was approved by the US Food and Drug Administration last May, but with caveats due to potential adverse effects. Takeda is conducting clinical trials in dengue endemic countries before seeking regulatory approval.