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 […]
DHHS Secretary RFK, Jr. and USDA Secretary Both Say “No” to Bird Flu Vaccine for Chickens
Opinion | Secretary of Health and Human Services Robert F. Kennedy, Jr announced on Mar. 4, 2025 that the avian influenza (“bird flu”) vaccine should not be given to chickens in the U.S. based on emerging evidence that injecting poultry with avian influenza virus (AIV) vaccine could lead to mutations accelerating evolution of the animal […]
Texas Man and Dairy Cattle Test Positive for Bird Flu
A man in Texas has tested positive for the H5N1 bird flu after direct exposure to infected dairy cattle. While this is the second recent case of bird flu identified in humans in the United States, it is the first time the disease has been found in dairy cattle.1 The first case of H5N1 in […]
Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly
On June 1, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) COVID-19 biologic for children as young as six months to five years old. The application is for a three-dose regimen, […]
FDA’s Expert Panel Recommends COVID-19 Booster Dose for Seniors and Others, Rejects Booster Dose for Children
Despite not convening the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) last month to vote on effectiveness and safety of the Pfizer-BioNTech COVID-19 vaccine (licensed under the name COMIRNATY), the U.S. Food and Drug Administration (FDA) convened the advisory committee on Friday, Sept. 17, 2021 to vote on booster doses of the vaccine.1 The […]
The FDA Has a History of Rushed Drug Approvals
Two weeks ago, the Pfizer COVID-19 vaccine was reported as the first COVID-19 vaccine to receive full approval from the U.S. Food and Drug Administration (FDA) for individuals aged 16 and older.1 But, for some, questions remain regarding conflicting discrepancies of the wording surrounding the approval.2 While the FDA’s report states that full approval was […]