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. 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.

The ability of women to choose whether, when, and how many children to have is essential to advancing the health and well-being of women and their families. In fact, research shows that expanding global access to contraception could reduce maternal deaths by nearly one-third and child deaths by one-quarter. Yet today, 218 million women in low- and middle-income countries have an unmet need for modern contraceptives. New contraceptive innovations are urgently needed to help close this contraceptive gap, including tools that are suitable and convenient for women who live far from health care settings and multipurpose products that combine contraception with HIV prevention. In recognition of World Contraception Day, GHTC is testing our readers’ knowledge of the history of contraceptive innovation. Your challenge for each question below: Name that contraceptive method. Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k

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.

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. COVID-19 vaccine trials in the United States, several of which are now in phase 3, have so far not included pregnant women or women who are breastfeeding, and only one potential US-market vaccine manufacturer—AstraZeneca—has begun testing in children. Vaccine candidates are customarily tested first in healthy adults, the population deemed most likely to provide clear results on vaccine efficacy and be at lowest risk for side effects, often leaving out younger populations and women who are pregnant. As manufacturers have been starting to broaden their volunteer pools to other typically underrepresented and at-risk populations—for example, adults over the age of 65 and people with HIV—some experts and advocates remain concerned about the lack of data regarding pregnant women and children.The US Food and Drug Administration (FDA) recently granted emergency use authorization (EUA) to SalivaDirect, a saliva-based COVID-19 diagnostic test developed by researchers at the Yale School of Public Health and funded by the National Basketball Association (NBA). The test joins several other saliva-based tests that have been greenlit by FDA in recent months. SalivaDirect’s Yale-based research team is now working with other labs to develop more saliva-based diagnostics, including one developed at the University of Illinois at Urbana-Champaign, which also received EUA last week. Researchers hope that increased availability of saliva-based tests—which often do not require administration by a trained health care worker and cost less than the standard nasopharyngeal swab tests—will improve speed and affordability of COVID-19 detection.Pharmaceutical companies and research centers, supported by the European Union (EU), have created a 37-member initiative working to advance research and development (R&D) to combat the COVID-19 pandemic. Called the Corona Accelerated R&D in Europe (CARE) initiative, the research-focused consortium has three main goals: screen libraries to identify existing compounds that have potential to be repurposed against COVID-19, perform in silico screening to find new small molecules that fight SARS-CoV-2, and apply approaches like fully human phage and yeast display to the discovery of virus-neutralizing antibodies. The initiative is one of several organizational collaborations working on strategies against COVID-19 and will work to ensure its efforts integrate with and complement other programs, with plans to operate for the next five years.