Biologics

FDA Panel Determines Next Flu Vaccine Composition

Despite an HHS decision to cancel (see earlier story) a 3/13-planned Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to select the strains and the composition of next season’s influenza vaccines, the agency convened an interagency meeting on the same date to adopt recommendations for vaccine manufacturers and the virus strains to be used for the 2025-2026 U.S. flu season.

An FDA notice says that “following a thorough and comprehensive review of U.S. and global surveillance data,” the panel agreed to recommendations that are similar to the previous year’s strain selection. “With today’s action, the FDA does not anticipate any impact on timing or availability of vaccines for the American public,” it adds.

The panel comprised scientific and public health experts from FDA, Centers for Disease Control and Prevention, and Department of Defense. Key issues discussed included:

Data and information on flu virus strains that are circulating in the U.S. and globally;
Data and information on mid-season vaccine effectiveness of current vaccines; and
Information on potential vaccine virus strains for use in manufacturing next season’s flu vaccines.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome