Pre-filled Syringe Version of GSK’s Shingles Vaccine Approved by FDA
On July 17, 2025, officials at the U.S. Food and Drug Administration (FDA) granted a license to GSK plc (formerly GlaxoSmithKline) to distribute a pre-filled syringe version of Shingrix (Zoster Vaccine Recombinant Adjuvanted) vaccine to control outbreaks of shingles (herpes zoster) in adults. The pre-filled syringe version of Shingrix was approved for use by adults […]
Push for National Bird Flu Vaccine Program as USDA Points to Falling Egg Prices After Gains in Biosecurity Containment
Publicity about avian influenza (H5N1) infecting chickens, turkeys and cows in the United States1 and globally has been widespread for several years as fears about the possibility of bird flu epidemics among humans have led to calls for acceleration of development and use of animal and human bird flu vaccines.2 3 4 5 In February […]
FDA Approves Yeztugo as Injectable Product to Prevent HIV in Adults and Adolescents
Last week, Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir), the company’s injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP). Yeztugo is not labeled a “vaccine” but is a pharmaceutical product intended to reduce the risk of acquiring human immunodeficiency virus (HIV) via sexual activity […]
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 […]
FDA Approves MenQuadfi Meningococcal Vaccine for Six-Week-Old Infants
The U.S. Food and Drug Administration (FDA) has licensed Sanofi’ SA’s four-valent MenQuadfi meningococcal vaccine for use in infants aged six weeks to 23 months old to prevent invasive meningococcal disease. Previously approved for children aged two and older, MenQuadfi is now the first meningococcal vaccine included on the U.S. Centers for Disease Control and […]