Solid phase III efficacy results for Moderna Inc.’s seasonal influenza vaccine, mRNA-1010, may lead the company to resubmit a BLA for a flu/COVID-19 combo shot it has been developing. The top-line data showed Moderna’s flu vaccine produced a superior relative efficacy that was 26.6% higher than a comparator standard-dose seasonal influenza vaccine in people ages 50 and older.
Despite the controversies swirling around the June meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP), the reconstituted committee delivered good news to Merck & Co. Inc. when it voted 5-2 June 26 to recommend that infants younger than 8 months who are not protected by maternal vaccination get one dose of a monoclonal as they head into their first respiratory syncytial virus season.
Although the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) was scheduled to vote June 25 on recommendations for maternal and pediatric respiratory syncytial virus vaccines, it adjourned by pushing that vote to the second day of the meeting. But before leaving for the day, it got an earful of comments from pediatricians, nurses and even a retired FDA scientist urging the CDC to reinstate the 17 committee members Health and Human Services Secretary Robert Kennedy dismissed two weeks earlier and replaced with eight new members.
Barely a day before the eight new members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are supposed to hold their first meeting, Sen. Bill Cassidy, R-La., called for the June 25 meeting to be postponed.
Cidara Therapeutics Inc. will meet with the FDA to discuss strongly favorable phase IIb results from its randomized, double-blind, placebo-controlled phase IIb Navigate trial testing CD-388 for the prevention of seasonal influenza in healthy, unvaccinated adults aged 18-64. Meanwhile, shares of the San Diego-based firm (NASDAQ:CDTX) closed June 23 at $44.95, up $23.93, or 113.8%, as Wall Street learned that the study met its primary endpoint, turning up a statistically significant prevention efficacy for each of three dose groups in people given a single shot at the beginning of the flu season.
The June 25-26 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) will be anything but business as usual. In wiping the slate clean just two weeks before the panel was to meet, Health and Human Services Secretary Robert Kennedy made sure of that.
Researchers from Purdue University and the U.S. Centers for Disease Control and Prevention have recently developed a novel influenza vaccine candidate that uses a bovine adenoviral (BAd) vector to deliver nucleoprotein (NP) antigens from both influenza A and B viruses, along with an autophagy-inducing peptide (C5) to enhance cellular immune responses, particularly T-cell responses.
The funding boost Moderna Inc. had expected via a roughly $590 million Biomedical Advanced Research and Development Authority award now looks to be off the table. The company disclosed May 28 that the U.S. Department of Health and Human Services (HHS) said it will terminate the award for late-stage development and right to purchase pre-pandemic influenza vaccines.
While current influenza vaccines primarily target the variable hemagglutinin protein, the slower-evolving neuraminidase presents a promising target for the development of new vaccines providing broader protection.
At the recent European Society of Clinical Microbiology and Infectious Diseases (ESCMID) meeting in Vienna, Longhorn Vaccines & Diagnostics LLC presented data on the neutralizing antibody responses of LHNVD-202, an unconjugated composite peptide vaccine.
