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 […]
CDC Vaccine Advisory Panel Purged
On June 9, 2025, U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr. fired all 17 members of the U.S. Centers for Disease Control and Prevention’s (CDC) committee that makes national vaccine policy—the Advisory Committee on Immunization Practices (ACIP). “A clean sweep is necessary to reestablish public confidence in vaccine science,” Secretary Kennedy […]
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 […]
“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 […]
U.S. Government Expands Mpox Vaccine Stockpile With $144 Million Order for Freeze-Dried Jynneos
The U.S. government is bolstering its emergency vaccine reserves with a $144 million purchase of a freeze-dried version of the Jynneos vaccine, designed to protect against both mpox (also known as monkeypox) and smallpox. Danish pharmaceutical company Bavarian Nordic A/S, the vaccine’s manufacturer, announced it will begin production and supply in 2026.1 2 Freeze-Dried Vaccine […]
‘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 […]