GSK is collaborating with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to investigate whether GSK’s shingles vaccine, Shingrix (zoster vaccine recombinant), could reduce the risk of dementia.
The research plan follows multiple retrospective observational studies, which suggest a potential link between shingles vaccination – specifically with Shingrix – and a lower likelihood of developing dementia. However, given unmeasured confounding factors, GSK has cautioned that these studies cannot establish causation.
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The new study will analyse electronic health records from the UK’s National Health Service (NHS), focusing on approximately 1.4 million individuals who are 65 or 66 years old. Researchers will assess how shingles vaccination affects dementia risk while accounting for variables such as age, sex, and existing medical conditions. The study is expected to take four years to complete.
Interest in the potential cognitive benefits of Shingrix was highlighted by a 2024 study published in Nature, which leveraged a natural experiment created by the transition from live to recombinant shingles vaccines. The study found that recipients of the recombinant vaccine had a significantly lower risk of dementia over six years, with a 17% increase in diagnosis-free time – equivalent to 164 additional days without a dementia diagnosis for those eventually affected.
The effect observed across various analyses, was more pronounced in women, and was stronger compared to other vaccines commonly administered to older adults, including influenza and tetanus-diphtheria-pertussis vaccines. The study’s authors called for further research into the underlying biological mechanisms and a large-scale randomised controlled trial.
In the UK, the recombinant zoster vaccine Shingrix, is offered to all adults turning 65, those aged 70 to 79 years, and those who are 50 years and above with a severely weakened immune system. It is the only US Food and Drug Administration (FDA)-approved shingles vaccine and has dominated the market since its US approval in 2017, outperforming MSD’s now-discontinued Zostavax. In 2020, Zostavax was discontinued in the US given Shingrix’s better effectiveness and safety. The UK Health Security Agency (UKHSA) announced in September 2023 that all newly eligible individuals would receive Shingrix instead of Zostavax.
GSK’s vaccine generated £3.36bn ($4.35bn) in sales in 2024, as per the company’s financials. According to GlobalData’s Pharma Intelligence Center, Shingrix sales will surpass $5bn by 2030.
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