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 Vaccine Only 36 Percent Effective This Year
The U.S. Centers for Disease Control and Prevention (CDC) reported that the 2025–2026 influenza vaccine showed reduced effectiveness compared to previous seasons. Researchers linked the lower performance to the emergence of a new influenza A(H3N2) subclade that differed from the strain used to manufacture the vaccine.1 The CDC reported overall flu shot effectiveness at 36 […]
CDC’s ACIP Forms Workgroup to Back New Lyme Disease Vaccine and Monoclonal Antibody Products
At an Apr.15-16, 2025 meeting of the U.S. Centers for Disease and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), it was announced that a workgroup had been formed to further development of a new vaccine for Lyme disease. The first session of the new group will take place in May with a presentation scheduled […]
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, […]