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. As COVID-19 vaccine trials continue and expand, several plans for allocation of an approved vaccine are being formed. Preliminary guidance from a strategic advisory group at the World Health Organization, which some experts have said needs more detail before it can be actionable, outlines groups of people who should have priority access to vaccines and urges high-income countries to ensure that low- and middle-income countries receive vaccines early in allocation. Draft recommendations from the National Academies of Sciences, Engineering, and Medicine, developed in response to requests from the Centers and Disease Control and Prevention and National Institutes of Health for vaccine allocation in the United States, also outlines priority groups, but goes a step further to rank those groups in a tiered approach, starting with health care workers and first responders. Both strategies address and emphasize vaccine access for disadvantaged groups, and both plans will continue to be developed in the upcoming months.Computer vision startup Gauss and biotech company Cellex recently announced their development of the first rapid COVID-19 diagnostic test able to be performed fully at home, with no laboratory involvement. The antigen test, developed by Cellex, requires its user to take a nasal swab from both nostrils and then place the swab in a small vial filled with a buffer solution. An AI app, developed by Gauss, then analyzes a picture of the rapid test to deliver results within 15 minutes. The test is still under development, and the companies will be pursuing US Food and Drug Administration emergency use authorization in upcoming months with the hopes of making the tool “as widely available as possible.”Preliminary results from a 1,000-person study indicated positive results for Eli Lilly’s anti-inflammatory treatment in shortening COVID-19 recovery time. The study, sponsored by the National Institute for Allergy and Infectious Diseases, tested Eli Lilly’s rheumatoid arthritis drug baricitinib in combination with Gilead’s remdesivir, which has previously been shown to reduce COVID-19 recovery time. The results announced last week, which have not yet been published or reviewed by independent scientists, showed participants given baricitinib recovered one day sooner than those given remdesivir alone. Eli Lilly plans to pursue emergency use approval of the drug for hospitalized COVID-19 patients and, if approved, proposes selling it through its normal commercial means.

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.

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.