Biologics

Panel Backs Monovalent XBB Variant Covid Vaccine

FDA’s Vaccines and Related Biological Products Advisory Committee 6/15 voted 21 to 0 that the Covid-19 vaccination program for the 2023-2024 season should contain a monovalent vaccine comprising the XBB-lineage variant.

Panel members essentially agreed with an FDA briefing document released in advance of the meeting that stated: “while vaccines based on the original virus strain can still be protective against severe disease, protection wanes with time and is reduced against subsequent waves of variant viruses. Both real-world evidence and immunogenicity data suggest that a vaccine composition that more closely matches circulating virus strains can significantly improve vaccine-induced immunogenicity and protection.”

Agency reviewers said that the current sublineages under consideration include XBB.1.5, XBB.1.16, or XBB.2.3. The three variants have a similar spike protein, and a vaccine that targets any of the three should be effective, experts told the panel. The three vaccine makers — Pfizer-BioNTech, Moderna, and Novavax — indicated that they can produce sufficient supplies by September.

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