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.