Breakthroughs Blog: COVID-19

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.The University of Minnesota’s Center for Infectious Disease Research and Policy last week announced the launch of a roadmap outlining a detailed strategy for the development of broadly protective and widely suitable vaccines to address future COVID-19 variants and other coronaviruses. The roadmap lays out the need for five broad and intersectional streams of work from virology to financing that will be necessary to break down the siloes of current vaccine development to achieve better coordination, accountability, and access. The initiative comes as a response to the COVID-19 pandemic, which is the third time in two decades that a coronavirus has become a public health crisis.A man in Germany has become at least the third person living with HIV formally declared HIV-free after undergoing a procedure in 2013 to replace his cancerous bone marrow cells with donor stem cells that contained a mutation making them effectively HIV-resistant. There remain questions about the full effects of the transplant and the factors behind the successful elimination of HIV in the body, even after follow-up studies. Experts say it is unlikely this procedure would ever be rolled out widely in people without leukemia due to high risk of a person rejecting donor marrow, but other ongoing and planned studies are looking at the potential of genetically modifying a patient’s own stem cells to include the HIV-resistant mutation.The United States is seeing a concerning rise in cases of syphilis, which has seen various cycles of rises and declines over the past century. There are few researchers that study syphilis, and the development of new diagnostics, treatments, and preventive tools has proved challenging because of past inability to grow the fragile Treponema pallidum bacterium that causes the disease in a lab and because of the virus’s ability to evolve resistance to antibiotics. A new technique that allows for lab-grown bacteria along with recent, promising studies of treatments and diagnostics for the disease provide hope. However, there is wide agreement that a vaccine is needed to eliminate the disease and the potential of resistance, and researchers are far from introducing a potential candidate.

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.

The US Agency for International Development (USAID) released a new report on its global health research and development (R&D) programs for fiscal year 2022 that includes unprecedented insight into the product development programs the agency supported—and highlights the need for additional, dedicated resources for global health research.Why it matters: The report gives insight into an agency that is a key sponsor of global health product development.Due to a lack of commercial incentive for industry investment, most global health research is supported by public funders, most notably the US government.Several US agencies support global health research, but USAID is the only agency with a mandate to improve global health and development. The agency excels at pushing products through the end of the research pipeline and advancing tools to suit the needs of people in low-resource settings.What’s new: This report includes an unprecedented 13-page appendix detailing USAID’s individual product-level investments. By our count, USAID supported at least 59 products in 2021 covering multiple health areas and product types.By the numbers: In 2021, USAID spent US$165 million in baseline funding and $50 million in COVID-19 supplemental funding on health product development and research to assess the best way to implement new products and practices.Research spending from baseline funds increased slightly over the prior year (+$4 million) — but continued to decline as a proportion of total global health spending. In 2021, proportionate spending on research dropped slightly to 5.1 percent, continuing a years-long pattern. If the trend continues, GHTC estimates that proportionate spending on R&D will drop to 4.2 percent by 2026 unless Congress passes a policy like the Supporting Innovative Global Health Technologies (SIGHT) Fund to direct more dedicated funding to R&D.Our take: GHTC applauds the release of the report and the additional detail provided by USAID. We call policymakers’ attention to the continued need for additional, dedicated resources for global health research at USAID that this report exposes.