Despite Safety Concerns, FDA Approves Moderna’s mRNA Flu Shot
On Aug. 5, 2026, the U.S. Food and Drug Administration (FDA) approved Moderna’s seasonal flu shot, mFLUSIVA (mRNA-1010), making it the first messenger RNA platform for seasonal influenza in the United States. The decision permits health care providers to use mRNA technology for annual influenza vaccination in eligible age groups.1 FDA regulators approved mFLUSIVA to […]
Inside the FDA’s ‘Cover-Up’ of Child Deaths Linked to COVID Vaccines
In September 2025, then-U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary publicly acknowledged that the agency was investigating reports of child deaths following COVID-19 vaccination. “We do know at the FDA… that there had been children who have died from the COVID vaccine,” Makary said during a CNN interview. By that stage, however, a […]
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 […]
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 Has No Plans to Put Black Box Warning on COVID Vaccines
So, first of all, it’s been known that there have been rare cases of death following the COVID shot that have been published in The New England Journal of Medicine, it came out in a Senate subcommittee report, and we have patient testimonials from families out there, so this is nothing new. But the moral […]
FDA Won’t Add “Black Box” Warning to COVID-19 Shots
News outlets have recently reported that the U.S. Food and Drug Administration (FDA) was considering adding a box warning (known for many years as a “Black Box” warning) to COVID-19 shots. A boxed warning appears prominently at the top of a drug’s prescribing information and represents the FDA’s strongest safety alert. The agency uses it […]