Expert review of vaccines · 2026
A self-controlled case series study on the safety of a live attenuated herpes zoster vaccine in China.
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Cao Xiang, Wei Mingwei, Huo Xiang, Liu Yuanbao, Xu Ming, Wang Xiaoshan, Huang Xianzhang, Ma Hui, Xu Na, Lu Qiang, Ma Shihua, Jin Pengfei, Li Jingxin
Аннотация
BACKGROUND: Herpes zoster (HZ), caused by varicella-zoster virus, primarily affects the elderly. In May 2023, the first domestically produced live attenuated zoster vaccine was approved for use in adults aged 40 years or older in China.
RESEARCH DESIGN AND METHODS: We conducted a self-controlled case series study to collect hospitalization events among 25,000 vaccinated adults (April 2020-December 2023, 5 regions) during the risk period (0-42 days) and the control period (72-162 days). Conditional Poisson regression models and conditional logistic regression models were applied to compare the risk of hospitalization.
RESULTS: The rate ratio of hospitalization following immunization was 0·381 (0·323-0·450). Compared with those in control period, the incidence rates of the following hospitalization events decreased: RRs of 0·297 (0·203-0·435) for stroke, cerebrovascular, and nervous system diseases; 0·296 (0·205-0·527) for cardiovascular diseases; 0·183 (0·054-0·627) for genitourinary system diseases; 0·246 (0·155-0·391) for respiratory, thoracic, and mediastinal diseases; 0·238 (0·089-0·635) for diseases of eye and adnexal diseases; and 0·202 (0·053-0·766) for skin and subcutaneous tissue diseases.
CONCLUSIONS: This study confirms the safety of the live attenuated zoster vaccine, demonstrating that vaccination does not increase the risk of hospitalization and may even reduce the incidence of hospitalization.
RESEARCH DESIGN AND METHODS: We conducted a self-controlled case series study to collect hospitalization events among 25,000 vaccinated adults (April 2020-December 2023, 5 regions) during the risk period (0-42 days) and the control period (72-162 days). Conditional Poisson regression models and conditional logistic regression models were applied to compare the risk of hospitalization.
RESULTS: The rate ratio of hospitalization following immunization was 0·381 (0·323-0·450). Compared with those in control period, the incidence rates of the following hospitalization events decreased: RRs of 0·297 (0·203-0·435) for stroke, cerebrovascular, and nervous system diseases; 0·296 (0·205-0·527) for cardiovascular diseases; 0·183 (0·054-0·627) for genitourinary system diseases; 0·246 (0·155-0·391) for respiratory, thoracic, and mediastinal diseases; 0·238 (0·089-0·635) for diseases of eye and adnexal diseases; and 0·202 (0·053-0·766) for skin and subcutaneous tissue diseases.
CONCLUSIONS: This study confirms the safety of the live attenuated zoster vaccine, demonstrating that vaccination does not increase the risk of hospitalization and may even reduce the incidence of hospitalization.