The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19.
U.S. Health and Human Services Secretary Robert Kennedy is facing a second lawsuit challenging his replacement of all the members of the Advisory Committee on Immunization Practices (ACIP) and seeking to undo the CDC’s Jan. 5 revision of its childhood immunization schedule.
A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors.
Amid an ongoing court challenge to the current composition of the CDC’s Advisory Committee on Immunization Practices (ACIP), the committee’s Feb. 25-27 meeting has been removed from its calendar.
In a recent study, researchers from Stony Brook University Renaissance School of Medicine and Cold Spring Harbor Laboratory investigated whether in vivo targeting of gastrointestinal tissues via foodborne delivery of Lm-based cancer vaccines could control tumor growth in murine models of colorectal cancer.
A week after catching Moderna Inc. and its investors off guard with a refuse-to-file letter, the U.S. FDA has reversed course on the company’s BLA submission seeking approval of seasonal influenza vaccine mRNA-1010, now agreeing to review the application and setting an assigned PDUFA date of Aug. 5, 2026.
A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in combination with the Australian Government and philanthropic donors, is the first multisite pediatric study to evaluate individualized mRNA vaccines designed specifically for each child's cancer.
The use of DNA scaffolds could mark a turning point in HIV vaccine design. Scientists at Scripps Research and the Massachusetts Institute of Technology (MIT) have created a new vaccine platform based on DNA origami, a material that the immune system does not recognize as a threat, avoiding unwanted responses.
Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49, having traded as low as $36.66 as investors learned of the RTF letter, which Moderna said is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-BLA-submission talks.
Zhejiang Difference Biological Technology Co. Ltd. (Diff Biotech)’s proprietary nasal spray influenza attenuated live vaccine, DIFF-flu, has received clinical trial approval from China’s National Medical Products Administration (NMPA).
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