Clinical Trials Now Required for Annual COVID Shots Given to Healthy Adults
On May 20, 2025, the U.S. Food and Drug Administration (FDA) announced that new clinical trials will be required to approve annual COVID-19 booster shots for healthy adults under age 65. In a joint editorial published in the New England Journal of Medicine, FDA commissioner Marty Makary, MD and the director of the FDA’s Center […]
FDA Approves MenQuadfi Meningococcal Vaccine for Six-Week-Old Infants
The U.S. Food and Drug Administration (FDA) has licensed Sanofi’ SA’s four-valent MenQuadfi meningococcal vaccine for use in infants aged six weeks to 23 months old to prevent invasive meningococcal disease. Previously approved for children aged two and older, MenQuadfi is now the first meningococcal vaccine included on the U.S. Centers for Disease Control and […]
Meningitis B Vaccine to Be Used for Gonorrhea in England
In August 2025, England will become the first country to offer a vaccine for gonorrhea after cases exceed 85,000 in 2023—the highest gonorrhea levels since recordkeeping began in 1918. The program, offered through the United Kingdom’s National Health Service (NHS), will repurpose the meningitis B vaccine, routinely given to infants, in an attempt to reduce […]
FDA, CDC Halt Use of Chikungunya Vaccine in Adults 60+ After Two Deaths Reported
On May 9, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) recommended a temporary pause in the use of Ixchiq, a live virus vaccine designed to prevent chikungunya virus infection, in adults aged 60 years and older. The recommendation follows reports of serious post-marketing adverse […]
Flu Shot Recipients “More Likely” to Get Influenza Than Unvaccinated
The American Medical Association (AMA) cites that the influenza vaccine is estimated to be 40-60 percent effective at preventing serious infections or death from the influenza virus that affects up to 40 million Americans every year. However, for the 2024-2025 flu “season” the influenza vaccine not only missed the mark on effectiveness, but is linked […]
HHS Halts Funding for Development of Next-Generation COVID Biologics
The U.S. Department of Health and Human Services (DHHS) has stopped U.S. government funding for the development of next-generation COVID-19 biologics by two companies, GeoVax, Inc. of Atlanta, Georgia and CastleVax, Inc. of New York. The project had been funded by Project NextGen, a Biden administration initiative under the U.S. Center for the Biomedical Advanced […]