DOI: 10.6084/m9.figshare.28039340.v1
title: A prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the recombinant zoster vaccine in Chinese adults ≥50 years of age

description: This post-marketing surveillance study evaluated the safety of the adjuvanted recombinant zoster vaccine (RZV) in Chinese adults, given the limited country-specific safety data accumulated since the 2019 licensure of RZV in China for adults ≥ 50 years of age (YOA). This descriptive, prospective cohort study enrolled adults ≥ 50 YOA who voluntarily received RZV per routine clinical practice in six centers in China. The primary outcomes were occurrence, intensity, and causal relationship to vaccination of medically attended adverse events (MAEs) within 30 days post-any dose. The occurrence and causal relationship to RZV of serious AEs (SAEs) within 30 days post-any dose, and of SAEs and potential immune-mediated diseases (pIMDs) from dose 1 until 12 months post-last dose were secondary outcomes. The exposed set included 3,300 adults (mean age [standard deviation]: 61.2 [7.4] years; 67.1% female), of whom 3,175 completed the study. Fifty-six MAEs were recorded in 42 (1.3%, 95% confidence interval [CI]: 0.9–1.7%) participants; ≥1 grade 3 MAE was reported in six (0.2%, 0.1–0.4%) participants; 15 MAEs (in nine [0.3%, 0.1–0.5%] participants) were considered RZV-related. Within 30 days post-any dose, 12 SAEs were reported in 10 (0.3%, 0.1–0.6%) participants, while 29 SAEs in 22 (0.7%, 0.4–1.0%) participants were reported from post-dose 1 until 12 months post-last dose. The three reported fatal SAEs were not considered RZV-related. Three of the total seven pIMDs were considered RZV-related. The observed descriptive patterns of MAEs, SAEs, and pIMDs did not indicate safety concerns following RZV administration among Chinese adults ≥ 50 YOA. <b>What is the context?</b>Herpes zoster, or shingles, is a painful rash caused by the reactivation of the latent chickenpox virus.The adjuvanted recombinant zoster vaccine, or RZV, was shown to be well tolerated and to effectively prevent shingles in healthy adults aged 50 years or older.Limited data on real-world safety of RZV, in terms of health problems occurring after vaccination in routine medical practice, are available in China, where RZV was licensed for use in 2019. Herpes zoster, or shingles, is a painful rash caused by the reactivation of the latent chickenpox virus.The adjuvanted recombinant zoster vaccine, or RZV, was shown to be well tolerated and to effectively prevent shingles in healthy adults aged 50 years or older.Limited data on real-world safety of RZV, in terms of health problems occurring after vaccination in routine medical practice, are available in China, where RZV was licensed for use in 2019. <b>What is new?</b>We analyzed data from 3,300 Chinese adults aged 50 years or older who voluntarily received at least one dose of RZV as part of routine clinical practice.No safety concerns following receipt of RZV were identified in this population. We analyzed data from 3,300 Chinese adults aged 50 years or older who voluntarily received at least one dose of RZV as part of routine clinical practice.No safety concerns following receipt of RZV were identified in this population. <b>What is the impact?</b>The results add important knowledge to the body of evidence regarding the safety of RZV in Chinese populations. The results add important knowledge to the body of evidence regarding the safety of RZV in Chinese populations.