As global populations age, the urgency to tackle both infectious and neurodegenerative diseases is intensifying. Interestingly, recent research points to a possible connection between the shingles vaccine and a reduced risk of dementia—offering a new perspective on preventive health strategies. With both clinical and regulatory implications, this unexpected link is gaining the attention of healthcare professionals and policymakers alike.
Shingles, caused by the reactivation of the varicella-zoster virus (VZV), typically affects adults over the age of 50 and can lead to severe nerve pain and complications. Vaccines like Shingrix have been highly effective in preventing shingles and are currently recommended by public health agencies, including the CDC and EMA, for older adults. However, emerging data suggest these vaccines might also reduce the risk of dementia by up to 20% (Langan et al., 2022).
Regulators are watching these developments closely. While the shingles vaccine has not been approved for dementia prevention, real-world evidence is influencing discussions about broader indications. For instance, the European Medicines Agency and the U.S. FDA are increasingly interested in post-market safety data and secondary benefits of approved vaccines, particularly when those benefits address major public health burdens like Alzheimer’s disease and other dementias.
The biological connection lies in the inflammatory process. The varicella-zoster virus can trigger neuroinflammation, a condition closely linked to cognitive decline and neurodegeneration. By preventing shingles outbreaks, the vaccine may reduce the frequency and severity of these inflammatory events. Moreover, some researchers suggest that the vaccine could enhance immune responses that aid in the clearance of harmful proteins, such as beta-amyloid, in the brain (Itzhaki, 2018; Barda et al., 2023).
Still, regulatory agencies are cautious. The current findings are based primarily on observational studies, which, while promising, do not establish causation. Regulators emphasize the need for randomized controlled trials to substantiate any expanded health claims. Nonetheless, these early signals are shaping future clinical research guidelines and post-market surveillance priorities, particularly within frameworks like the FDA’s Real-World Evidence (RWE) Program.
For healthcare providers, these findings offer an added incentive to encourage vaccination among eligible adults. For regulators, they present an opportunity to reconsider how secondary vaccine benefits could factor into public health recommendations and labeling decisions. As the healthcare landscape evolves, multi-purpose vaccines that address both infectious and chronic diseases could become a central strategy in improving population health outcomes.
In conclusion, while the shingles vaccine’s primary indication remains clear, its potential to reduce dementia risk is reshaping conversations around both clinical practice and regulatory oversight. Continued research, supported by robust data and proactive regulatory engagement, will be key to unlocking the full value of this dual-purpose vaccine.
EMMA International has a professional staff dedicated to the regulatory process and advancing these lifesaving treatments. Contact us today by phone at (248) 987-4497, or email at info@emmainternational.com to learn more about how EMMA International can help.
References:
- Barda, N., et al. (2023). Association between shingles vaccination and reduced risk of dementia: A population-based cohort study. The Lancet Regional Health – Europe, 23, 100537.
- Itzhaki, R. F. (2018). Herpes simplex virus type 1 and Alzheimer’s disease: increasing evidence for a major role of the virus. Frontiers in Aging Neuroscience, 10, 324.
- Langan, S. M., et al. (2022). Shingles vaccination and risk of dementia: a retrospective cohort study using primary care data from Wales. PLOS Medicine, 19(6), e1003982.
- World Health Organization. (2023). Dementia. Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia