Drugs

FDA Regulatory Pathway Needed for Dementia Vaccine Trials: Opinion

An opinion article is calling on FDA acting commissioner Kyle Diamantas to establish a formal regulatory framework for evaluating vaccines as potential interventions to prevent dementia, arguing that the absence of clear guidance is hindering the launch of large-scale clinical trials.

In an open letter published by Clinical Trial Vanguard, editor-in-chief Moe Alsumidaie cites a recent Nature Medicine paper that advocates for randomized trials of the live-attenuated shingles vaccine Zostavax as a potential strategy for reducing dementia risk.

The article points to growing epidemiological and mechanistic evidence linking reactivation of the varicella-zoster virus (VZV) to an increased risk of dementia, including research suggesting that VZV infection may contribute to cerebrovascular and neurodegenerative changes associated with Alzheimer's disease.

Alsumidaie argues that while both Zostavax and the recombinant shingles vaccine Shingrix are already licensed, FDA lacks a clear regulatory pathway for approving a vaccine-based dementia prevention indication. Current supplemental Biologics License Application (sBLA) processes were developed around infectious disease endpoints rather than long-term neurodegenerative outcomes, he contends.

The opinion piece notes that uncertainty around acceptable clinical endpoints, evidentiary standards and safety requirements could discourage sponsors from undertaking large, multi-year prevention studies that may require thousands of participants.

To address the issue, Alsumidaie urges CBER to convene a public workshop on vaccine-based dementia prevention trials, issue draft guidance outlining regulatory expectations for sponsors pursuing dementia prevention indications, and develop written recommendations on participant selection and safety monitoring for studies involving live-attenuated vaccines.

The article argues that regulatory clarity, rather than funding alone, may be the key obstacle to advancing research into whether existing vaccines could reduce the risk of dementia and Alzheimer's disease in aging populations.

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