Breakthroughs Blog: NIH

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. 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.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. 

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.Dexamethasone, an inexpensive, decades-old drug is showing promise for treating COVID-19, per unpublished, preliminary results from a study called Recovery that was funded by the United Kingdom. The preliminary results indicated that the drug reduced the risk of death for patients on ventilators by 35 percent, those receiving oxygen by 20 percent, and overall mortality by 17 percent. Immediately following the results, the United Kingdom granted approval for use of the drug to treat COVID-19. According to FiercePharma, UK officials have enough dexamethasone stockpiled to treat 200,000 patients.  A recent study lends support to anecdotal evidence that blood type and genetics may be linked to worse outcomes from COVID-19 illness. Last Wednesday, a team of European researchers published a study in The New England Journal of Medicine indicating that people with type A blood have a 45 percent higher risk of catching COVID-19 and sliding into respiratory failure and people with type O blood have a 35 percent lower risk of developing respiratory failure compared to people with other blood types. Scientists are still unsure why blood type might be correlated with COVID-19 outcomes, but a nascent hypothesis is that it could be linked to blood clotting risk. The researchers also found that a cluster of genes are associated with higher risk of developing severe COVID-19 by 77 percent.A project led by researchers from Scripps Research, GHTC member IAVI, and the University of California San Diego School of Medicine published research in Science detailing a set of antibodies discovered in recovered COVID-19 patients that provide powerful protection against SARS-CoV-2. In theory, the antibodies could be given to patients who are just developing the illness to prevent progression to severe disease and to protect people who are at higher risk for contracting COVID-19. To discover the antibodies, the scientists isolated more than 1,000 distinct antibody-producing immune cells, obtained genetic sequences from these cells to produce more antibodies, and then tested the antibodies’ effectiveness against blocking the virus in vitro. The researchers discovered several antibodies that, even in small quantities, could block the SARS-CoV-2 virus. The work was funded by the US National Institutes of Health, IAVI, and the Bill & Melinda Gates Foundation, among others.