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 […]
Poland, Romania Resist Brussels Court Order to Pay $2.2 Billion to Pfizer
A court in Belgium has ordered Poland and Romania to proceed with paying €1.9 billion ($2.2 billion) for purchasing mRNA COVID-19 shots from Pfizer, Inc. and BioNTech SE in a case brought by Pfizer three years ago. The lawsuit and court judgement has intensified a broader legal dispute over mRNA COVID shot contracts signed by […]
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 […]
Guinea-Bissau Hepatitis B Vaccine Trial in Newborns Sparks Ethics Debate
The World Health Organization (WHO) and some members of the U.S. Congress have raised ethical concerns about a U.S. Centers for Disease Control and Prevention (CDC) funded clinical trial examining the hepatitis B vaccine for newborns in Guinea-Bissau.1 The study would support a randomized controlled trial led by researchers at the University of Southern Denmark […]
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 […]