Breakthroughs Blog: Medicines

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.

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. Researchers in Rwanda, amid insufficient COVID-19 testing capacity, have created an algorithm to maximize the efficiency of pooled testing—the method of testing batches of samples first, followed by individual sample testing if a batch test comes back positive. Instead of retesting every individual sample after a batch test comes back positive, the new algorithm indicates a way to create and overlap smaller groups from the batch that will lead to identification of the positive samples. While the complexity of the method is of concern to some researchers, the approach also shows potential to be an important tool for resource-limited settings battling the COVID-19 pandemic, given the reduction in total number of required retests and the speed of results. The algorithm is currently being developed into a software that can be used by lab technicians to minimize human error.A research team at the University of California, San Francisco (UCSF), synthesized an anti-coronavirus compound similar to an infection-fighting antibody found in llamas, alpacas, and other camelids. The molecule, a type of nanobody, is among the most potent compounds for fighting COVID-19 identified in lab tests to date, according to the researchers, although it has yet to go through animal studies or human clinical trials. Nanobodies are about a quarter of the size of most antibodies, and work by nestling into small spaces in proteins and blocking viruses from attaching to and infecting cells. The nanobody made in the UCSF lab is stable enough to be converted into a dry powder and aerosolized, with potential to be self-administered by simple inhaled sprays to the nose and lungs. The researchers have published their lab results in a preprinted, non-peer reviewed paper and are in the process of finding a partner to assist in clinical testing, manufacturing, and distributing the compound.The Africa Centers for Disease Control and Prevention (CDC) announced Thursday the launch of a continent-wide study of COVID-19 antibodies, after a smaller study and testimony from global health experts indicated that current official numbers might be underestimating infection and death rates. With a median age of 19, Africa’s young population might be indicative of high levels of asymptomatic infection. The study, to begin in the upcoming weeks, will include all countries in Africa, likely starting with Liberia, Sierra Leone, Zambia, Zimbabwe, Cameroon, Nigeria, and Morocco. The continent surpassed 1 million confirmed cases on August 7, with more than 24,000 deaths recorded.

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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) authorized last week its first COVID-19 antibody tests that estimate the level of antibodies in a person’s bloodstream, indicating the strength of their immune response. Since April, FDA has greenlit 33 antibody tests, all of which provide a basic positive or negative result. The two recently approved tests, developed by Siemens Healthineers, are new versions of previous yes-or-no antibody tests that provide “semi-quantitative” readings of a patient’s antibody levels. Both tests are chemiluminescent immunoassays, tagging antibodies with reagent markers and producing more light when more antibodies are present. The new tests will provide an additional tool in evaluating COVID-19 immune response, but FDA also warned that results from these tests do not provide reason to stop following COVID-19 prevention guidelines and emphasized the remaining unknowns about antibodies and protective immunity.Research on monoclonal antibodies—lab-made imitations of natural antibodies—to treat COVID-19 is accelerating as two National Institutes of Health (NIH) clinical trials were launched last week. The trials, one focusing on patients early in disease progression and one on sicker, hospitalized patients, are intended to determine whether a monoclonal antibody developed by Eli Lilly has an effect on symptom duration and recovery time. Success as a COVID-19 treatment could also lead to exploration of monoclonal antibodies as an infection prevention measure. Scientists hope monoclonal antibody treatment can provide a “bridge” of immunity before a vaccine is available.The Serum Institute of India announced it will be receiving US$150 million in funding from the Bill & Melinda Gates Foundation in partnership with Gavi, the Vaccine Alliance, to produce 100 million COVID-19 vaccine doses for low- and middle-income countries. The Serum Institute will manufacture vaccines from developers AstraZeneca and Novavax once approved and make them available for procurement, priced at $3 per dose, in 92 countries via a Gavi advance purchase commitment as part of the COVID-19 Global Vaccine Access (COVAX) Facility initiative, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization. COVAX aims to deliver 2 billion doses of approved, effective vaccines against COVID-19 by the end of 2021.