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 […]
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 Licenses Moderna’s mNEXSPIKE COVID Shot for Individuals at High Risk for Severe COVID Disease
On May 30, 2025, the U.S. Food and Drug Administration (FDA) licensed mNEXSPIKE (mRNA-1283), a newly developed mRNA COVID-19 biologic for individuals who have previously received any COVID shots and are either 65 years of age or older, or between 12 and 64 years old with at least one underlying medical condition that increases their […]