FDA Database Analysis Finds No Link Between Shingles Vaccine and Gout

Sheryl Kluberg, PhD, SM
Credit: Harvard Medical School

A new study seeks to dispel the notion that receipt of the shingles vaccine could increase the risk of new-onset gout among US adults.

A real-world, retrospective safety study with a self-controlled risk interval (SCRI) design leveraging data from the US Food and Drug Administration’s Sentinel System, results indicate there was no statistically significant association between recombinant zoster vaccine and incident gout in adults aged 50 years or older.¹

“This SCRI analysis using real-world data from a large administrative claims database found no statistically significant association in the risk of incident gout in the 30-day risk period relative to the control period following [recombinant zoster vaccine] exposure,” wrote investigators.¹ “Furthermore, the precision of the effect estimate excludes a clinically meaningful increase in risk. This result was consistent across all secondary and sensitivity analyses.”

Among the most common forms of inflammatory joint disease, gout represents a familiar hurdle for practitioners, especially those providing care for older patient populations. Citing previous purporting discordance in the rate of gout events among patients receiving the recombinant zoster vaccine, a team led by Sheryl Kluberg, PhD, SM, a research scientist in Therapeutics and Infectious Disease Epidemiology in the department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, sought to explore associations of recombinant zoster vaccine receipt and new-onset gout using real-world. Launched in 2016, the FDA’s Sentinel System is the agency’s national electronic system for monitoring safety of FDA-regulated medical products and aggregates data from multiple health systems and research partners from across the US.^1,2

The system provided information related to 461,313 individuals who received 1 or more recombinant zoster vaccines doses aged 50 years or older between January 1, 2018, and December 31, 2019 for inclusion in the analysis. Additional inclusion criteria for the study included having at least 730 days of medical and drug coverage prior to recombinant zoster vaccine exposure, allowing 45-day gaps, and continuous enrollment with no gap following recombinant zoster vaccine exposure.²

Among this cohort, 1264 individuals had an occurrence of gout during the 60 days following recombinant zoster vaccine exposure. Of these, investigators determined 302 individuals had events considered to be incident gout. The cohort with incident gout had a mean age of 72.5 (SD, 8.3) years, 65.9% were male and 50.0% were from the South Census Bureau region.¹

For the purpose of analysis, days 1 to 30 following recombinant zoster vaccine exposure were considered the risk window and days 31 to 60 were considered the control window. Investigators assessed risk ratios of gout in each window using a conditional Poisson model. Investigators planned sensitivity analyses assessing dose-specific risk, risk based on compliance with recommended dose spacing, with adjustment for seasonality, and with restoration to the pre-COVID-19 era.¹

Upon analysis, results indicated 50.7% of the 302 individual cohort experienced gout events during the risk window and 49.3% experienced gout events during the control window (RR, 1.03; 95% CI, 0.81 to 1.29). Additionally, investigators highlighted the results of all sensitivity analyses were consistent with the results of the primary analysis.¹

“This analysis, using real-world data from a large patient cohort, supported by a rigorous study design and careful sensitivity analyses, found no evidence of an increased risk of incident gout in the 30 days following [recombinant zoster vaccine] exposure in US adults aged ≥50 years,” investigators wrote.¹

References:

1. Kluberg SA, Simon AL, Alam SM, et al. Risk of incident gout following exposure to recombinant zoster vaccine in US adults aged ≥50 years. Semin Arthritis Rheum. Published online July 14, 2024. doi:10.1016/j.semarthrit.2024.152518
2. Center for Drug Evaluation and Research. FDA’s Sentinel initiative. U.S. Food and Drug Administration. March 8, 2024. Accessed August 9, 2024. https://www.fda.gov/safety/fdas-sentinel-initiative.