The vaccine dominoes continue to fall in the U.S. This time one fell on the FDA’s Vaccines and Related Biological Products Advisory Committee, as one of Health and Human Services Secretary Robert Kennedy’s most outspoken critics was removed from the panel nearly a year and a half before his term was to expire.
South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.
Effective vaccines against Staphylococcus aureus remain out of reach: 10 candidates that showed promise in preclinical animal models have failed in clinical trials. Researchers at Third Military Medical University and collaborators reasoned that one of the reasons might be that 70%-80% of the population has developed antibodies to the pathogen.
Immunoprecise Antibodies Ltd. is advancing its universal dengue vaccine program. Following the discovery and validation of a uniquely conserved dengue epitope using its Lensai platform, the company is now advancing to preclinical manufacturing for in vivo testing and virus neutralization analysis.
French vaccines specialist Osivax SAS has been awarded $19.5 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund work on its universal influenza A vaccine.
Worrisome new signals caused the U.S. FDA – which earlier this month OK’d revised labeling for Valneva SE’s chikungunya virus vaccine Ixchiq – to suspend the product’s license altogether. Regulators pointed to four added reports of serious adverse events consistent with chikungunya-like illness, and told Valneva, of Saint Herblain, France, that the company must stop U.S. shipping and sales of the product. Shares (NASDAQ:VALN) closed Aug. 25 at $9.43, down $2.21, or 19%.
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has awarded Baxiva AG $3 million to develop its multivalent glycoconjugate vaccine.
Researchers from the California Institute of Technology and collaborating institutions have developed a novel HIV vaccine candidate, a new germline-targeting Env SOSIP trimer called 3nv.2, that is designed to elicit antibodies targeting three key epitopes on the HIV envelope protein.
Beijing Luzhu Biotechnology Co. Ltd.’s shingles vaccine LZ-901 outperformed GSK plc’s Shingrix (HZ/su) vaccine in a head-to-head phase III trial. A recombinant herpes zoster vaccine candidate independently developed by Luzhu, LZ-901 is the company’s core product.