Research Roundup: Newborn sepsis treatment trial, Ebola outbreak antivirals trial, Generic TB drug approval

Last week, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend approval of Moderna’s mRNA influenza vaccine for older adults. In a Phase 3 trial in more than 40,000 adults in 11 countries during the 2024-2025 flu season, the vaccine demonstrated significantly better protection than standard-dose shots. Moderna's vaccine also uses mRNA technology, meaning it can be updated more quickly to match circulating flu strains compared to traditional vaccines that use egg-based methods. After initially agreeing to review the vaccine, the FDA had previously raised concerns about the Phase 3 trial for the vaccine, prompting backlash from vaccine and public health experts, before deciding to go ahead with its review. Following the recommendation, the FDA will make a final decision on approval, which is expected by early August.The Global Health Innovative Technology (GHIT) Fund has started an emergency framework to surge support and funding for the development of rapid and point-of-care diagnostic technologies in response to the Ebola outbreak caused by the Bundibugyo virus in the Democratic Republic of the Congo and Uganda. There are currently no approved vaccines, therapeutics, or point-of-care diagnostics for Bundibugyo virus. GHIT Fund is prepared to support fast-track funding for infections caused by filoviruses, which include Ebola, with the aim of advancing a diagnostic test, particularly one that is suited to low- and middle-income countries with limited infrastructure, that can improve control capacity for this and future outbreaks.  Inflammatix is collaborating with the University of Nebraska Medical Center to explore the use of the company’s diagnostic test platform for hantaviruses after the recent hantavirus outbreak exposed gaps in testing capacity due to limited technology and testing standards. Inflamattrix’s TriVerity test is a blood-based test that used machine learning to detect infection. It previously received clearance from the US Food and Drug Administration as a sepsis test in 2025. The partners are aiming to develop a tool that can assess the early signatures of infection in people with high-risk exposure to the virus, which could help improve early response capacity in future outbreaks.  

Fatherhood is often framed as a life milestone, but far less attention is paid to men’s role in deciding if or when that milestone occurs. Nearly half of all pregnancies, around 121 million globally each year, are unintended, highlighting major gaps in contraceptive access and limitations in today’s methods. Boosting investment in the research and development (R&D) of new and improved contraceptive options, including for men, offers a critical opportunity to strengthen reproductive autonomy, advance gender equality, and help prevent unintended pregnancy. The gendered burden of pregnancy prevention Without male contraceptive options beyond condoms and vasectomy, the physical, financial, logistical, and emotional burden of pregnancy prevention has long fallen on women.  While a wide range of options exist for women, from pills to injections, patches, and implants, an estimated 257 million women worldwide who want to avoid pregnancy are not using safe, modern methods of contraception due to a combination of social barriers (such as cultural or religious opposition), structural challenges (including limited access to high-quality services or education), and technological limitations (such as unpleasant side effects or short duration of protection). These barriers are especially pronounced in low- and middle-income countries—in sub-Saharan Africa, nearly one in four women has an unmet need for contraception.  Addressing this gap requires expanding options for women, such as methods that are longer acting, more discreet, have fewer side effects, and require fewer health care provider visits, as well as expanding contraceptive choice for men. New male contraceptive options to replace or complement female contraceptives could help rebalance the shared responsibility for family planning, empower men to have greater autonomy over their own reproductive health decision-making, and contribute to reducing unintended pregnancy. The gap in male contraception Limited innovation in male contraception reflects decades of underinvestment—not a lack of demand. Research shows strong interest in male contraceptives among men in diverse settings worldwide, alongside high trust in male partner birth control use among female partners, with preferred product types and attributes varying across contexts. Despite this clear demand, progress in male contraceptive innovation has been slow, in part due to the limited funding landscape. Contraceptive R&D has relied heavily on public and philanthropic funding, with the Gates Foundation playing a lead role. Private-sector engagement has remained limited due to perceived uncertainty about the potential market, unclear regulatory pathways, high development costs, and the broader historical underinvestment in contraception R&D. The continued success of products currently in clinical development has the potential to spark greater engagement in the field from diverse investors. Male contraceptive innovations on the horizon  While the pipeline lags behind demand, several exciting and innovative tools and approaches are advancing through clinical development.  The most advanced product in development is a reversible hormonal gel, NES/T, which can be applied once daily to the upper arms and shoulders. The gel is absorbed through the skin and suppresses sperm production. Originally developed by the Population Council and the US National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development, it is now being advanced by Contraline, which recently announced the launch of Phase 3 trial planning. Nonhormonal male contraceptive options are another promising area of research because they target sperm function directly, avoiding hormone-related side effects. Contraline’s ADAM™ is a nonhormonal injectable device that blocks sperm flow for an extended period before dissolving. It has demonstrated encouraging safety and efficacy data in a first-in-human trial, with Phase 2 planning underway. YourChoice Therapeutics and Columbia University’s YCT529 is a first-in-class nonhormonal daily pill that suppresses sperm production and has shown positive results in a small, early human trial.  The path ahead When the US Food and Drug Administration approved the first oral contraceptive pill for women in 1960, its rapid, widespread adoption transformed reproductive autonomy and expanded economic, education, and career opportunities for women, carrying benefits that reverberated across entire economies and contributed to broader gender equality. Continued innovation in female contraceptives remains essential to ensure options better fit the needs and lifestyles of women worldwide.  But this progress should also be matched by investment in novel male contraceptives. Ensuring that everyone who wants to use contraception can access safe, effective, and acceptable options will expand choice, strengthen reproductive autonomy, and contribute to a more equitable and resilient future for family planning at a time when reproductive health protections are increasingly constrained worldwide.