Clinical Trials Now Required for Annual COVID Shots Given to Healthy Adults
On May 20, 2025, the U.S. Food and Drug Administration (FDA) announced that new clinical trials will be required to approve annual COVID-19 booster shots for healthy adults under age 65. In a joint editorial published in the New England Journal of Medicine, FDA commissioner Marty Makary, MD and the director of the FDA’s Center […]
Government Cancels $700 Million in Funding for Moderna’s Bird Flu Biologic
The U.S. government has cancelled a contract worth over $700 million awarded to Moderna, Inc. for late-stage development of an mRNA bird flu biologic for humans, as well as the right to purchase the shots. Earlier this year, the Department of Health and Human Services (DHHS) Biomedical Advanced Research and Development Authority (BARDA) issued the […]
Moderna Withdraws Application for Combination COVID and Flu Vaccine
Moderna, Inc. withdrew its application for United States licensure for its combination COVID-19/Influenza vaccine known as mRNA-1083. The company stated the decision came “in consultation with” the U.S. Food and Drug Administration (FDA).1 The decision came just one day after the FDA announced the agency would require new clinical trials for approval of annual COVID […]
COVID-19 Misleading Advertising Campaign Lawsuit Against Pfizer Challenges PREP Act Liability Shield
A United States district judge has remanded a lawsuit filed by the state of Kansas against Pfizer, Inc. back to state court. This move may prevent the Public Readiness and Preparedness (PREP) Act from shielding the pharmaceutical giant from liability for Its misleading advertising campaign promoting its mRNA COVID-19 shot (Comirnaty).1 The Kansas attorney general, […]
“Universal Flu Vaccine” Unveiled by DHHS
On May 1, 2025, the U.S. Department of Health and Human Services (DHHS) announced plans to develop a universal influenza vaccine that would eliminate the need for annual flu shots and offer protection against other pandemic influenza threats, including bird flu and respiratory disease caused by coronaviruses. The initiative, called “Generation Gold Standard,” will cost […]
‘All New Vaccines’ in the U.S. to Undergo Placebo-Controlled Safety Testing
On Apr. 30, 2025, the U.S. Department of Health and Human Services (DHHS) announced that all newly developed vaccines will now be required to undergo placebo-controlled clinical trials before being licensed by the U.S. Food and Drug Administration (FDA). This landmark policy shift comes after years of advocacy from consumer organizations critical of vaccine safety […]