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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.Last week, AstraZeneca paused its phase 3 COVID-19 vaccine trial after a participant exhibited symptoms of transverse myelitis. On Saturday, the company announced the UK trials of its vaccine candidate would resume, citing the conclusion of its investigation into the adverse reaction. AstraZeneca’s clinical trials in the United States, Brazil, and South Africa remain paused. No further details on the affected participant or illness have been released, to protect patient confidentiality. The UK trial continuation was greenlit by Britain’s regulatory authority, and the review process included analysis from independent boards overseeing trials on several other COVID-19 vaccine candidates.German diagnostic test maker Qiagen plans to launch a COVID-19 antigen test that processes about 30 samples per hour and provides results within 15 minutes. The company plans to launch two versions of the test in November, one for labs and one for point-of-care use, and has not yet received authorization from the US Food and Drug Administration (FDA). Studies on the diagnostic indicated 100 percent accuracy in identifying those without the disease and at least 90 percent accuracy in identifying those with the disease. The test uses an eHub, a small portable device, to analyze nasal swab samples. Qiagen expects to be able to produce several million tests per month when it launches and scale up to more than 10 million per month in 2021.The United States has indicated it will not participate in the COVID-19 Vaccine Global Access (COVAX) Facility, a global effort to develop and distribute COVID-19 vaccines effectively and equitably. The initiative—co-led by the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), and Gavi, the Vaccine Alliance—currently includes more than 170 countries and hopes to work against “vaccine nationalism,” which WHO Director-General Dr. Tedros Adhanom Ghebreyesus has said exacerbated the pandemic and supply chain failures. The Trump administration said the United States will continue to work toward a vaccine that maintains FDA standards.

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. Three new studies, recently published in the journal JAMA, support the use of steroids to treat severely ill COVID-19 patients, generating mounting evidence that these common drugs are the most effective treatment for the virus found to date. The use of steroids to treat COVID-19 had been under debate over the last few months, as some worried that they could prevent the body from fighting off the virus effectively as a side effect of tamping down the immune system’s potentially deadly overreaction to infection. Dexamethasone, a steroid that was found to reduce deaths among the most serious COVID-19 cases, has been in use in some areas since a major June UK study demonstrated its efficacy. The new research, published jointly by three different global teams, further backs the use of dexamethasone as well as another steroid, hydrocortisone. Positive results on steroid use are especially significant because of their wide availability and inexpensive prices, making them an accessible treatment option.Study results released last week, gathered from tests on more than 30,000 people in Iceland analyzing immune response to COVID-19, found evidence of a lasting antibody presence post-infection. Previous smaller studies have suggested COVID-19 antibodies might disappear quickly after infection, making the unknowns of lasting immunity and future infection a question of interest for researchers. The new study, conducted by Amgen-subsidiary deCODE Genetics, used nasal swabs and blood samples from 30,576 individuals to examine infection levels and immune response. Results showed that after the first wave of antibodies, which may fade after a month or two as other studies have reported, a longer-lasting second wave of antibodies forms, which was shown to remain stable for four months. While these findings are not necessarily applicable to all countries’ populations, and several unknowns remain, the results provide an optimistic sign for vaccine makers hoping to confer long-lasting COVID-19 immunity.The National Institutes of Health (NIH) is backing nine additional COVID-19 test manufacturers as part of its Rapid Acceleration of Diagnostics initiative (RADx), adding US$129.3 million in funding to scale up production of point-of-care screening tests and high-throughput laboratory assays. Many of the test candidates are using innovations that have moved from labs to point of care in five to six months—a process that usually takes years—according to NIH National Institute of Biomedical Imaging and Bioengineering (NIBIB) Director Bruce Tromberg. NIBAB helps lead RADx, which hopes to deliver products and services to the public this fall.

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) last week granted emergency use authorization (EUA) to a rapid, inexpensive COVID-19 diagnostic test developed by Abbott Laboratories that delivers results within 15 minutes. The test, which works by detecting antigens unique to SARS-CoV-2, is the first COVID-19 antigen diagnostic that does not require specialized equipment to read the results. The diagnostic does require a health care professional to obtain a nasal swab from the patient, which is then inserted into a credit card–sized device. A strip inside changes color if SARS-CoV-2 proteins are detected. Abbott has said the company intends to produce tens of millions of the diagnostic in September and 50 million in October, to be priced at US$5 per test.The National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS) will begin studies on GS-441524, a compound similar to remdesivir, as a potential treatment for COVID-19. The compound, developed by Gilead, has not yet been tested in humans, but research suggests it works in the same way as remdesivir and is active against SARS-CoV-2. Gilead says it has primarily pursued remdesivir due to evidence that it is more effective than GS-441524 at blocking viral replication in test tubes and animal models and was more active against multiple coronaviruses in lab tests. Other researchers have said GS-441524 could have similar or superior effects to remdesivir, is more easily synthesized enabling easier creation of oral versions, and does not cause much toxicity. NCATS expressed its intention to further study the compound in an August 20 letter and has said it expects to conduct studies quickly and make results available to the research community.Scientists are looking into an alternative vaccine delivery route to combat COVID-19: nasal sprays. The majority of vaccines—and all current COVID-19 vaccine candidates in clinical trials—are delivered as an injection into muscle to optimize the human immune response and prevent people from becoming sick. A nasal spray, some researchers say, could be more effective in helping to prevent the spread of disease, as COVID-19 infection can take hold in the nose or throat before systemic immunity from a vaccine kicks in, allowing infection to still spread to others. The nasal spray could provide a local immune response in the nose and throat as well as a systemic response through the entire body. Multiple researchers are in early stages of developing nasal spray vaccines, including one with inspiration from an existing nasal spray flu vaccine.