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

Abstract

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.

Keywords

• Herpes zoster
• adjuvanted recombinant zoster vaccine (RZV)
• post-marketing
• safety
• adverse events
• potential immune-mediated diseases