Post-Marketing Surveillance of Adverse Events for the Recombinant Zoster Vaccine Among the Population over 50 Years Old in Hangzhou, China DOI Creative Commons
Jing Wang, Jian Du, Yan Liu

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(12), P. 1376 - 1376

Published: Dec. 6, 2024

Objectives: This study aimed to evaluate the safety profile of recombinant zoster vaccine (RZV) after its marketing in China. Methods: We present a descriptive analysis and signal assessment adverse events following immunization (AEFI) associated with RZV between September 2020 December 2023. The data collected includes demographic characteristics classification AEFI cases, while was evaluated using reporting odds ratio (ROR). Results: In total, we documented 275 cases vaccination, rate 76.22/10,000 doses administered. Notably, only one case classified as serious, rates were significantly higher among females, individuals aged 50–59 years, those residing rural areas. Furthermore, for first dose exceeded that second dose. Among reported 98.91% attributed product-related reactions, 97.45% initially by either recipient or their guardians. interval vaccination symptom onset predominant within 3 d vaccination. disproportionality identified five positive signals—fever (37.5–38.5 °C), injection site reactions greater than 5 cm, pain, Henoch Schönlein purpura (HSP), swelling—which suggests stronger association expected threshold. Conclusion: summary, demonstrated favorable profile. However, continued monitoring research on long-term implications are needed.

Language: Английский

Post-Marketing Surveillance of Adverse Events for the Recombinant Zoster Vaccine Among the Population over 50 Years Old in Hangzhou, China DOI Creative Commons
Jing Wang, Jian Du, Yan Liu

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(12), P. 1376 - 1376

Published: Dec. 6, 2024

Objectives: This study aimed to evaluate the safety profile of recombinant zoster vaccine (RZV) after its marketing in China. Methods: We present a descriptive analysis and signal assessment adverse events following immunization (AEFI) associated with RZV between September 2020 December 2023. The data collected includes demographic characteristics classification AEFI cases, while was evaluated using reporting odds ratio (ROR). Results: In total, we documented 275 cases vaccination, rate 76.22/10,000 doses administered. Notably, only one case classified as serious, rates were significantly higher among females, individuals aged 50–59 years, those residing rural areas. Furthermore, for first dose exceeded that second dose. Among reported 98.91% attributed product-related reactions, 97.45% initially by either recipient or their guardians. interval vaccination symptom onset predominant within 3 d vaccination. disproportionality identified five positive signals—fever (37.5–38.5 °C), injection site reactions greater than 5 cm, pain, Henoch Schönlein purpura (HSP), swelling—which suggests stronger association expected threshold. Conclusion: summary, demonstrated favorable profile. However, continued monitoring research on long-term implications are needed.

Language: Английский

Citations

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