Anna Kovacevich

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.

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. Moderna and Pfizer announced last week the launch of phase 3 clinical trials for their COVID-19 vaccine candidates, the first late-stage studies supported by Operation Warp Speed in the United States. Both vaccine candidates are mRNA-based, meant to induce an immune response by mimicking the virus. The 30,000-subject phase 3 trials—to be conducted in locations across the United States—will evaluate the safety and efficacy of the vaccines. Moderna, in partnership with the National Institute for Allergy and Infectious Diseases (NIAID), and Pfizer, in partnership with BioNTech, have said they hope to seek regulatory approval and start supplying vaccines by the end of the year.Sorrento Therapeutics has licensed a saliva-based rapid COVID-19 diagnostic test developed by a fertility lab at Columbia University. The test, COVI-TRACE, is single-step and contained within a small tube, requiring no laboratory equipment. It works by applying heat to saliva in the tube, inducing a reaction from enzymes and reagents to provide a result within 30 minutes. If positive, the enzymes and reagents will react to the presence of the virus’ RNA and turn the liquid from red to yellow. A preliminary, preprinted study produced a sensitivity level of 97 percent and a specificity level of 100 percent, indicating low rates of false negatives and false positives. Sorrento intends to pursue emergency use authorization from the US Food and Drug Administration (FDA) and scale up production of the test.As COVID-19 vaccine trials increasingly scale up, some advocate groups and individuals are pushing to ensure diverse representation in clinical research. Clinical diversity—the inclusion of diverse populations including racial and ethnic minorities, elderly people, and those with underlying medical conditions in clinical trials—helps ensure that research covers the different ways individuals might respond to drugs and therapies. When it comes to COVID-19, populations that have historically been underrepresented in clinical research are among the highest risk for infection and death. Data has shown that Black and Latino populations are three times more likely to be infected with COVID-19 than white people and twice as likely to die. Chronic kidney disease has been identified as one of the top risk factors for serious infection. Eight out of ten COVID-19 deaths reported in the United States have been of people ages 65 and older. Several vaccine developers have acknowledged the importance of representing high-risk communities in clinical trials, and recent FDA guidance “strongly encourages” the inclusion of diverse populations in clinical trials but does not mandate representation.

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 European Medicines Agency (EMA) issued a positive opinion on the monthly dapivirine vaginal ring, developed by GHTC member the International Partnership for Microbicides (IPM), for use by cisgender women 18 and older in developing countries to reduce HIV risk. The ring—designed to help address women’s unmet need for HIV prevention methods—is the first long-acting HIV prevention product. The EMA opinion recommended the ring’s use in combination with safer sex practices when daily oral pre-exposure prophylaxis (PrEP) is not used or cannot be used. Efficacy data indicated the dapivirine ring reduced women’s HIV risk by 35 percent and showed no safety concerns with long-term use. This EMA decision paves the way for review by the World Health Organization (WHO) and regulatory bodies in each country where it is intended for use. IPM is continuing market and implementation research and working on rollout plans, with a hope for making the ring available in some communities with urgent need sometime in 2021.Three laboratories working on COVID-19 vaccines released promising results last week, reporting their findings from early human trials. The three vaccine candidates—developed by Oxford University/AstraZeneca, CanSino Biologics, and Pfizer/BioNTech—all produced strong immune responses with antibody levels similar to those seen in patients who have recovered from COVID-19. The developers also indicated that immunity is likely to require a second vaccine dose. Scientists have cautioned that lab results from these early vaccine trials do not guarantee COVID-19 disease prevention. Among outstanding questions is the long-term efficacy and effects of these candidates, as the trials have only measured results over a few weeks. The three developers that released results last week—along with Moderna, which reported its vaccine candidate’s positive immune response the week prior—will continue further human trials in the upcoming months.A study conducted by the UK-based company Synairgen reported positive results for a potential new COVID-19 treatment method: an inhaled form of interferon beta, a naturally occurring antiviral protein more commonly used in its injectable form to treat diseases like multiple sclerosis. Results from the study of 101 patients, not yet published in a peer-reviewed journal, showed that hospitalized patients who received the treatment had a 79 percent lower risk of developing more debilitating symptoms and were twice as likely to recover without limitations compared to those receiving a placebo. The preliminary double-blind placebo-controlled study will be followed up with larger clinical trials.

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.Seventy-five countries submitted expressions of interests to join the COVID-19 Vaccine Global Access (COVAX) Facility, a new initiative to ensure fair and equitable vaccine distribution around the world. The 75 interested countries would fund vaccine production and distribution through their national budgets, supporting vaccine access among their own populations as well as in 90 lower-income countries through voluntary donations. COVAX would provide a guaranteed share of vaccine doses to cover 20 percent of each country’s population and act as a supplement to any deals individual countries make with vaccine manufacturers. The COVAX Facility is a key part of the Access to COVID-19 Tools (ACT) Accelerator vaccine pillar, which is led by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (CEPI); and the World Health Organization (WHO). The initial goal of the initiative is to raise US$2 billion to buy COVID-19 vaccines, according to Gavi. More than 100 COVID-19 vaccine candidates are currently in development around the world.In an open letter to National Institutes of Health (NIH) Director Francis Collins, more than 100 scientists called for human challenge trials to accelerate the development of a COVID-19 vaccine. During challenge trials, healthy volunteers are given a vaccine and then exposed to a virus to evaluate whether the vaccine prevents infection. While challenge trials are controversial, they would hasten the COVID-19 vaccine development process, as conventional efficacy trials can take months longer. Signatories of the letter also noted that challenge trials are more likely to yield interpretable results. Some US lawmakers already support the idea, and WHO guidance has stated that human challenge trials are ethical when in compliance with certain criteria.The Foundation for Innovative Diagnostics (FIND)—a GHTC member—and Cepheid, Inc., announced last week the launch of a new rapid molecular tuberculosis (TB) test that can simultaneously detect first- and second-line drug resistance. The Xpert® MTB/XDR test can provide TB drug-resistance profiles in less than 90 minutes and could be crucial in the fight against extensively drug-resistant TB (XDR-TB), the most complicated form of TB. Current methods for identifying drug-resistance profiles for XDR-TB can take up to 16 weeks to give results. Diagnosis and treatment of drug-resistant TB has been an essential part of TB elimination efforts for years. FIND and Cepheid have both conducted evaluations on the new test, and the data will undergo WHO review later this year.