Biologics

Panel to Examine Ongoing Covid Vaccine Modifications

FDA says it is holding a 1/26/2023 meeting of its Vaccines and Related Biological Products Advisory Committee to consider “whether and how the composition for primary doses of the currently available Covid-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward.”

The agency notes that since the initial authorizations of Covid vaccines, it has learned that protection wanes over time, “especially as the virus rapidly mutates and new variants and subvariants emerge. Therefore, it's important to continue discussions about the optimal composition of Covid-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

Additionally, FDA says presentations and discussions will “examine the state of the pandemic, the evolution of variants and subvariants, and the available effectiveness, safety and immunogenicity data with the current monovalent and bivalent vaccines. The agency will also consider the potential composition of the current and next generation of Covid-19 vaccines for primary and booster immunization. There will also be presentations from manufacturers and the FDA summarizing the manufacturing considerations and timelines related to vaccine composition changes.”

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