Top 5 Infectious Disease News Stories Week of March 1-8

Top FDA Approvals and Updates from February 2025 in Infectious Disease

In February 2025, several key FDA approvals and updates in infectious disease included the approval of Bavarian Nordic’s Vimkunya vaccine for chikungunya, providing a single-dose option for those aged 12 and older. The FDA also approved GSK's Penmenvy vaccine, offering protection against five meningococcal serogroups for individuals aged 10-25. A new treatment for complicated intra-abdominal infections, Emblaveo, was authorized, combining aztreonam and avibactam to address multidrug-resistant bacteria. bioMérieux’s BioFire FilmArray Gastrointestinal Panel Mid received FDA clearance, enabling quicker diagnoses of gastroenteritis. Additionally, Gilead’s lenacapavir for HIV prevention is set for a June 2025 decision, potentially offering a twice-yearly PrEP option. However, the FDA declined Invivyd’s request to expand pemivibart’s EUA for COVID-19 treatment. Concerns arose with the cancellation of the FDA’s flu vaccine advisory meeting, possibly delaying preparations for the 2025 season.

Global Guideline on Candidiasis, Part I: Diagnostics

A new guideline from the European Confederation for Medical Mycology (ECMM) provides updated diagnostic recommendations for candidiasis, with a focus on emerging pathogens like Candida auris. Developed in collaboration with the American Society of Microbiology (ASM) and the International Society for Human and Animal Mycology (ISHAM), the guideline emphasizes conventional culture-based methods, with recommendations to enhance sensitivity by increasing blood culture volumes and sets. It also stresses the importance of identifying Candida species to guide treatment and detect outbreaks. The guideline supports the use of MALDI-TOF mass spectrometry for species identification and PCR assays for blood testing, while cautioning that biomarkers like serum ß-D-glucan and mannan antigen assays should not be used in isolation. Additionally, chromogenic agars are recommended for detecting mixed yeast infections, particularly in high-risk patients. The guideline also notes the need for further research to optimize the use of biomarkers in guiding antifungal treatments.

RNA Medicines and Therapies Drive Healthcare Innovation

RNA-based medicines are revolutionizing healthcare, offering innovative solutions for diseases such as flu, cancer, malaria, and HIV. In an interview with Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, she highlighted how RNA technologies have expanded following the success of COVID-19 vaccines. RNA medicines are advancing into areas like flu prevention, with the potential for universal flu vaccines, and personalized cancer therapies, particularly for hard-to-treat cancers like pancreatic cancer and melanoma. Additionally, RNA solutions hold promise for global health challenges, such as malaria and HIV, and are improving the precision of treatments by targeting specific cell types. Broderick envisions RNA technology playing a key role in the future of healthcare, potentially transforming the way diseases are treated and paving the way for more effective, personalized, and adaptable therapies.

Synthetic Gel Shows Utility Across ABSSSI, Company Sees Other Indications

Recce Pharmaceuticals has developed a novel synthetic topical gel, R327G (RECCE 327), aimed at treating acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot infections (DFI). The gel, which has shown efficacy against multidrug-resistant bacteria, was initially tested as an intravenous formulation and later developed into a topical version after successful trials. In a recent phase 2 study, R327G demonstrated a 93% primary efficacy rate over 14 days, with rapid onset of action and no serious adverse events. The company plans to proceed with phase 3 trials in Australia for ABSSSI and DFI, and anticipates expanding clinical trials to the US for further development. R327G's broad-spectrum activity and speed of action could address ongoing challenges in treating resistant infections.

Vaxart's Oral Norovirus Vaccine: Key Study Findings and Future Plans

Vaxart, Inc. recently published promising results from its phase 1b trial of its first-generation oral norovirus vaccine, showing strong immune responses in elderly adults aged 55-80, a group typically less responsive to traditional injectable vaccines. The oral vaccine induced significant increases in serum antibodies and mucosal T-cell responses in older adults, with no notable differences from responses seen in younger populations. The vaccine, designed to target the intestine, also demonstrated efficacy in generating antibody responses in the nose and mouth, which could be vital for preventing respiratory infections like COVID-19 and flu. Vaxart is now advancing second-generation norovirus vaccine candidates, which have shown improved immunogenicity in animal models, and plans to move these into clinical trials by mid-2025. The oral vaccine platform offers advantages over traditional vaccines, such as avoiding cold storage and needle-stick injuries, and may help reduce virus transmission, even in breakthrough infections.