FDA Panel Backs mFlusiva mRNA Flu Shot for Elderly
Despite a number of significant limitations in the available safety and efficacy data for licensure review of Moderna, Inc.’s new mRNA influenza biologic mFlusiva, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee ((VRBPAC) voted on June 18, 2026 to recommend fast-tracked licensure of the first mRNA product to target […]
FDA Set to Review Moderna’s mFlusiva mRNA Flu Shot
An mRNA (messenger ribonucleic acid) influenza biologic developed by Moderna, Inc. is scheduled to be reviewed today by a U.S. Food and Drug Administration (FDA) advisory panel. The Vaccines and Related Biological Products Advisory Committee ((VRBPAC) will evaluate data on Moderna’s mFlusiva (formerly known as mRNA-1010) to determine if the product provides superior relative vaccine […]
Pfizer, BioNTech End mRNA COVID-19 Biologic Trial Early
After failing to recruit enough eligible volunteers to generate enough data in the U.S. to meet U.S. Food and Drug Administration (FDA) post-marketing evidence requirements, Pfizer, Inc. and BioNTech SE have halted a large clinical trial of their updated mRNA COVID-19 biologic. The study targeted healthy adults 50 to 64 years of age but fell […]
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 […]
Annual COVID Shot. Is it Inevitable?
In a recent interview, the newly appointed director of the U.S. Centers for Disease Control and Prevention (CDC) suggested that the agency may soon come out with a recommendation for Americans to be vaccinated for COVID-19 every year.1 2 Mandy Cohen, MD, MPH, who was sworn in as the 20th CDC director on July 10, […]
CDC, FDA Find Possible Link Between Pfizer’s Bivalent COVID Shot and Strokes
The U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said last week that they are investigating a possible link between Pfizer/BioNTech’s bivalent messenger RNA (mRNA) Comirnaty COVID biologic and an increased risk of a type of ischemic stroke among people 65 years of age and older. Data from the […]