Breakthroughs Blog: Research Roundup

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.PANTHER, a newly launched pan-African platform for emergency research and preparedness, aims to address the lack of clinical trials carried out on the continent, despite it facing a disproportionate amount of the global disease burden. The researchers behind the initiative see the platform as a way to ensure essential data is captured in clinical trials during active outbreaks of existing or newly emerging diseases, especially following the recent Marburg and Sudan ebolavirus outbreaks. PANTHER hopes to prepare around 80 percent of the groundwork for trials before an outbreak by targeting at-risk spots, creating a network of researchers and health care providers, and proactively engaging funders so that when an outbreak is identified, this foundation can be quickly leveraged to adapt trials to local contexts and specific disease characteristics.Last week, researchers announced promising results from a phase 1 clinical trial, supported by the US National Institutes of Health, looking at a temperature-stable tuberculosis (TB) vaccine that can be freeze-dried and safely stored at higher temperatures for months. The shot, given to 45 healthy adults in the study, was found safe, well-tolerated, and elicited measurable responses in the body. If further testing of the vaccine proves successful, the shot could be a clear alternative to the bacille Calmette-Guerin vaccine—the only licensed vaccine for TB, which is more sensitive and cannot be frozen— and break down barriers to vaccine distribution in low-income and low-resource settings around the world.A new paper found that more than 10 percent of people in rural Myanmar have been exposed to a diverse range of sarbecoviruses, a group of coronaviruses that includes Sars and Sars-Cov-2. Researchers also emphasized that the paper confirmed the risk of direct spillover from bats, especially in remote, rural areas. While there were no signs of human-to-human transmission of these viruses, the findings highlight the ongoing occurrence of spillovers and the need for surveillance of both disease outbreaks and rural areas with high wildlife-human interface, as well as ensuring strong biosecurity laboratory measures are in place.

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, a US Food and Drug Administration (FDA) advisory panel recommended approval of two vaccines for respiratory syncytial virus (RSV) for adults 60 and older, one by Pfizer and one by GlaxoSmithKline. The agency could grant formal approval to the vaccines in the coming months, making them the first shots available against RSV, a disease responsible for significant deaths and hospitalizations among older adults and young children. Other vaccines, as well as monoclonal antibody treatments, also in the pipeline could additionally address the yearly burden of RSV.The US Centers for Disease Control and Prevention (CDC) has issued a warning about a rise in extensively drug-resistant cases of Shigella, especially in gay and bisexual men, in the United States and other countries. Shigella is a highly infectious bacterial infection that causes an inflammatory diarrheal condition and is spread when infected fecal matter enters the mouth or nose. The European Centre for Disease Prevention and Control also released an alert about possible cases among recent travelers. Doctors have faced major challenges in identifying viable alternative antibiotics to treat these cases, underlining the need for greater focus on the research and development of new antibiotics.This year’s Conference on Retroviruses and Opportunistic Infections saw a myriad of presentations on how best to expand global access to the cabotegravir, or CAB-LA, which is a long acting, injectable form of preexposure prophylaxis (PrEP) used to prevent HIV infection. CAB-LA joins oral PrEP and the recently approved dapivirine vaginal ring as a third safe and effective biomedical HIV prevention option, for the first time allowing people an authentic choice among products. However, to ensure access and availability of these products, there remains a need for additional research on the use of CAB-LA in certain patient populations, including among people who inject drugs, and further research on effective delivery methods to expand uptake of oral PrEP.

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, the US Food and Drug Administration (FDA) announced that it is slowing down Emergency Use Authorizations (EUAs) of new in vitro diagnostics for COVID-19 and Mpox. The agency will continue reviewing tests that have already been submitted for authorization and is expected to review only some additional tests from experienced developers that use innovative technological approaches, fill a gap in need, or demonstrate potential for wide public health benefits. Instead, the agency is encouraging most developers to submit their tests through different review processes. Despite the end of the national emergency declaration for the COVID-19 pandemic on May 11, the 440 EUAs already granted will remain in effect as long as a separate agency-level EUA declaration determined by FDA continues.The World Health Organization (WHO) convened an emergency meeting of the Marburg virus vaccine consortium following the confirmation of the first-ever Marburg outbreak in Equatorial Guinea. During the meeting, five vaccine developers shared updates on their vaccine candidates for the disease. WHO is taking steps toward pursuing a real-time clinical trial for some of the candidates in alignment with the already-approved WHO clinical trial protocol for Marburg vaccines (which needs to be adapted to the country context) and in consultation with country officials. Sabin Vaccine Institute and Janssen’s candidates are in phase 1 clinical trials, while IAVI, Public Health Vaccines, and Auro Vaccines’ candidates are still in the pre-clinical development stage.A new study published last week found that a drug tested in mice could potentially be used as a birth control option for men. If successful in further trials, the drug would work as an on-demand contraceptive compared to other male contraceptives in the pipeline, like daily pills and gels, that researchers say are more complicated, time-consuming, and long-lasting. The drug works by preventing a molecular action from turning sperm “on” and activating them to pursue an egg. The researchers have founded a new company to move forward development of the drug but note it will likely be years before it is ready for testing in men.

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.A recent study found that an inexpensive, widely available antibiotic could sharply reduce the number of pregnant individuals in low- and middle-income countries who develop sepsis in childbirth, which is among the three leading causes of maternal deaths globally. The study, conducted in seven countries mostly in sub-Saharan Africa and Asia, showed that a single dose of the drug azithromycin during labor cut the risk of the mother developing sepsis by around 35 percent. Azithromycin is a generic drug, it has a long half-life, and it does not require refrigeration, making it an inexpensive and easy-to-deliver tool that could be widely adopted even in low-resource settings.Following the recent discovery of an outbreak of H5N1 on a Spanish mink farm, scientists have identified that the strain of the virus behind the outbreak contains a mutation that could make the virus more adaptable to mammals. While experts have stressed that there is no need panic, the outbreak is a reminder of the importance of disease surveillance and preparedness measures, especially as a new variant of H5N1 has spread among bird populations and spilled over into humans in recent years. Scientists have not detected any transmission of this latest strain among humans, although the mutation could increase the potential risk.Fungal pathogens are a growing threat to global public health, according to experts and the World Health Organization (WHO), which published a list of priority fungal pathogens last year. Resistance is exacerbating the threat. For example, Candida auris, Aspergillus fumigatus, and Cryptococcus neoformans, which WHO ranks among the four highest priority threats, have all shown resistance to current tools. There are also no vaccines for the top four critical infections identified. As aging populations and the climate crisis contribute to growing antimicrobial resistance, there is a strong need for improving surveillance capacity and investing in developing diagnostics, medicines, and other interventions for fungal infections, which currently account for less than 1.5 percent of all infectious disease research spending, according to WHO.