ACIP Majority Ignores Risks and Recommends Infants Get Merck’s RSV Monoclonal Antibody
On June 25, 2025, the majority of members of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) ignored risk warnings and voted for a recommendation that infants be given Merck & Co.’s monoclonal antibody, clesrovimab, marketed as Enflonsia. The committee advised using Enflonsia to prevent Respiratory Syncytial Virus […]
Massachusetts School District Will Exclude Unvaccinated Students This Fall
Newton Public Schools in Newton, Massachusetts will now require all students to be vaccinated before returning to school in the fall of 2025 unless they have a valid medical or religious exemption to vaccination. Superintendent Anna Nolin announced the policy change after a review prompted by a recent increase in chickenpox cases across the district. […]
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 […]
FDA Licenses Moderna’s mNEXSPIKE COVID Shot for Individuals at High Risk for Severe COVID Disease
On May 30, 2025, the U.S. Food and Drug Administration (FDA) licensed mNEXSPIKE (mRNA-1283), a newly developed mRNA COVID-19 biologic for individuals who have previously received any COVID shots and are either 65 years of age or older, or between 12 and 64 years old with at least one underlying medical condition that increases their […]
FDA Approves Novavax’s COVID-19 Vaccine With Restrictions
On May 16, 2025, the U.S. Food and Drug Administration (FDA) approved licensure of Novavax, Inc.’s Nuvaxovid protein-based COVID-19 vaccine, which has been available in the United States under Emergency Use Authorization (EUA) since July 2022.1 The decision for a full licensure was postponed while the new agency leadership under the current administration conducted a […]
FDA, CDC Halt Use of Chikungunya Vaccine in Adults 60+ After Two Deaths Reported
On May 9, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) recommended a temporary pause in the use of Ixchiq, a live virus vaccine designed to prevent chikungunya virus infection, in adults aged 60 years and older. The recommendation follows reports of serious post-marketing adverse […]