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 […]
FDA Launches New Consolidated Adverse Event Monitoring System
The U.S. Food and Drug Administration (FDA) has announced the launch of a new Adverse Event Monitoring System (AEMS) that consolidates adverse event reporting systems for different types of products licensed by the FDA, including the Vaccine Adverse Event Reporting System (VAERS) that was created under the 1986 National Childhood Vaccine Injury Act (NCVIA). The […]
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 […]
Moderna’s mNEXSPIKE mRNA COVID-19 Shot Approved by European Commission
The European Commission (EC) has granted marketing authorization for Moderna’s mNEXSPIKE mRNA COVID-19 shot, allowing it to be marketed across the European Union (U.N.). The authorization follows a regulatory review and permits all 27 E.U. Member States, as well as Iceland, Liechtenstein and Norway, to consider the shot for use within their vaccination programs. It […]
FDA Greenlights Review of Moderna’s mRNA Flu Shot After Application Amended
On Feb. 18, 2026, the U.S. Food and Drug Administration (FDA) agreed to review Moderna’s application for its mRNA influenza shot, known as mRNA-1010, after the company amended its submission to address regulatory concerns. The agency accepted the updated biologics license application and set a target action date of Aug. 5, 2026, allowing the shot […]
FDA Refuses to Review Moderna’s mRNA Influenza Shot License Application
The U.S. Food and Drug Administration (FDA) has declined to accept for review Moderna’s Biologics License Application (BLA) for its mRNA-based seasonal influenza shot, citing concerns about the completeness of the submission. The decision highlights the agency’s commitment to maintaining clear evidentiary standards for approving the licensing of new vaccines.1 On Feb. 3, 2026, the […]