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 […]
Combination mRNA COVID-Influenza Shot Recommended by European Medicines Agency
The European Medicine Agency (EDA) has recommended marketing authorization for Moderna’s mCombriax mRNA (messenger ribonucleic acid) shot. The product, also known as mRNA-1083, is a genetically engineered biologic targeting both influenza and COVID-19. It builds on work Moderna has done on its next-generation mRNA COVID shot known as mNexSpike and mRNA-1010.1 2 3 The recommendation […]
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 […]
Study Finds More MMR/MMRV Death Reports Than Deaths from Measles
A new study has found a significant number of deaths among infants and toddlers within days of receiving MMR/MMRV combination vaccines, particularly after the routine first-dose at 12 to 15 months, with reported deaths exceeding documented measles fatalities in the United States.1 The preprint, which examined Vaccine Adverse Event Reporting System (VAERS) death reports, identified […]
U.S. Researcher Wins $1.9 Million USDA Grant to Develop Novel Bird Flu Vaccine
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has awarded a three-year, $1.9 million grant to a researcher at the University of Missouri School of Medicine and the College of Veterinary Medicine to develop a novel vaccine against highly pathogenic avian influenza (HPAI) (“bird flu”) and Newcastle disease—another fatal, viral […]
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 […]