As U.S. regulatory uncertainty swirls around the vaccine space and health care in general, Vaxcyte Inc. stands poised for a readout of phase II infant data by the end of this quarter with VAX-24, the 24-valent pneumococcal conjugate vaccine (PCV). The San Carlos, Calif.-based firm will offer top-line safety, tolerability, and immunogenicity data, to be followed by top-line data with the booster dose by the end of this year.
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) has announced it will award US$2 million to Immunethep SA to develop a conjugated peptide-based vaccine to prevent infections from all invasive serotypes of Escherichia coli.
Io Biotech Aps has presented preclinical data regarding their Arg1-derived peptide cancer vaccine IO-112 as a potential immunotherapeutic that would allow controlling the tumor microenvironment.
With the U.S. FDA’s approval of Vimkunya, Bavarian Nordic A/S is now in the chikungunya virus infection mix along with Valneva SE’s Ixchiq. A single-dose, adjuvanted virus-like particle-based vaccine to protect against the chikungunya virus infection, Vimkunya is the first of its kind available in the U.S. for those age 12 and older.
A second pentavalent vaccine for preventing meningococcal disease has been approved by the U.S. FDA. GSL plc’s Penmenvy will now go up against Pfizer Inc.’s Penbraya, which had a two-year head start in the market.
Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
CSPC Pharmaceutical Group Ltd. has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for SYS-6017, an mRNA vaccine to prevent herpes zoster infections.
The development of an effective HIV vaccine remains an urgent public health need due to the high genetic variability and rapid mutation rates of the virus, which limit the generation of broadly neutralizing antibodies.
When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.
RSS
