Background The purpose of this study was to evaluate the effectiveness of the influenza vaccine during the 2024-2025 respiratory viral season.
Methods Employees of Cleveland Clinic in employment in Ohio on October 1, 2024, were included. The cumulative incidence of influenza among those in the vaccinated and unvaccinated states was compared over the following 25 weeks. Protection provided by vaccination (analyzed as a time-dependent covariate) was evaluated using Cox proportional hazards regression.
Results Among 53402 employees, 43857 (82.1%) had received the influenza vaccine by the end of the study. Influenza occurred in 1079 (2.02%) during the study. The cumulative incidence of influenza was similar for the vaccinated and unvaccinated states early, but over the course of the study the cumulative incidence of influenza increased more rapidly among the vaccinated than the unvaccinated. In an analysis adjusted for age, sex, clinical nursing job, and employment location, the risk of influenza was significantly higher for the vaccinated compared to the unvaccinated state (HR, 1.27; 95% C.I., 1.07 – 1.51; P = 0.007), yielding a calculated vaccine effectiveness of −26.9% (95% C.I., −55.0 to −6.6%).
Conclusions This study found that influenza vaccination of working-aged adults was associated with a higher risk of influenza during the 2024-2025 respiratory viral season, suggesting that the vaccine has not been effective in preventing influenza this season.
This study analyzed over 53,000 Cleveland Clinic employees and found that those who received the influenza vaccine during the 2024–2025 season were statistically more likely to contract influenza compared to those who remained unvaccinated. After adjusting for key factors like age, sex, job role, and location, the data showed a 27% higher risk of influenza among the vaccinated group (Hazard Ratio = 1.27). This led to a negative vaccine effectiveness estimate of −26.9%.