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U.S. Withdraws Financial Support from Pharma’s Arm GAVI

U.S. Withdraws Financial Support from Pharma’s Arm GAVI

The U.S. government has withdrawn a $1.2 billion pledge to the Global Alliance for Vaccines and Immunization (GAVI) originally made by the Biden administration. GAVI, which is officially known as Gavi, The Vaccine Alliance, is a public-private multilateral funding partnership launched in 2000 by the pharmaceutical industry, governments and private institutions and philanthropic organizations to […]

FDA Approves Yeztugo as Injectable Product to Prevent HIV in Adults and Adolescents

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

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

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

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 […]

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