Drugs

Chikungunya Vaccine Suspended Due to Safety Concerns

CBER has suspended Valneva Austria’s BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients. The vaccine was granted accelerated approval in 2023 for the preventing disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

An FDA notice says there has been one death from encephalitis directly attributable to the vaccine and over 20 reported serious adverse events that were consistent with chikungunya-like illness. “Reported serious adverse events have included 21 hospitalizations and 3 deaths,” it says. “Furthermore, the clinical benefit of the vaccine has not yet been verified in confirmatory clinical studies. CBER’s benefit-risk analysis broadly shows the vaccine does not have benefits outweighing risks, under most plausible scenarios.”

In May, FDA issued a safety communication that recommended a pause in the vaccine’s use in individuals 60 years of age and older while an investigation of postmarketing reports of serious adverse events was undertaken, including neurologic and cardiac events, in individuals who have received the vaccine.

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