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 […]
Florida Senate Advances Bill Allowing Vaccine Manufacturers to Be Sued in State Court
Florida lawmakers are moving legislation that would allow individuals injured by vaccines to sue manufacturers in Florida state courts. The bill passed a Senate committee with a 5-3 vote in January and is advancing through the legislative process.1 If passed, this legislation would mark a departure from decades of product liability immunity that has largely […]
FDA Commissioner on New Nutrition Guidelines, Flu Surge
There’s been a revolution in nutrition science recognizing that we have been misled with 60 years of dogma that has determined that we need to have a myopic focus on demonizing fat, for example. We now know that that’s not true. The field of nutrition has matured to recognize now the importance of protein, so […]
FDA Requires Vaccine Makers to Include Febrile Seizure Warning on Flu Shot Labels
The U.S. Food and Drug Administration (FDA) notified six influenza vaccine manufacturers on Jan. 9, 2026 that they must add a warning about the risk of febrile (fever) seizures to their product information labels, citing newly identified postmarketing safety data. The notices, issued under the FDA’s statutory authority to mandate safety labeling changes, were sent […]