2023-06-26-世界卫生组织-Results_of_Literature_Review_and_Survey_of_COVID-19_Vaccine_Safety_Assessment_Activities_5页_515kb

COVID-19 Vaccine Safety Assessment Activities Summary

Background

The assessment addressed the urgent need for COVID-19 vaccine safety evidence in 2021 by supporting international groups like COVAX's Vaccine Safety Working Group, CEPI, and WHO-Pharmacovigilance, focusing on collating global studies and identifying knowledge gaps.

Methods

A comprehensive literature review searched published COVID-19 vaccine safety studies up to January 27, 2023, including active vaccine safety surveillance (AVSS) and cohort event monitoring. A survey conducted between December 2021 and February 2022 gathered details on planned and ongoing activities from global institutions, covering aspects like study design, location, population, vaccines, and AEFI monitoring. All data sources are available on VIEW-hub.org.

Results

• Literature review identified 59 countries with published AVSS studies (Table), with the United States having the highest number (65 studies).
• Survey responses covered activities in 46 countries.
• Combined analysis revealed 82 countries with AVSS activities, including at least 36 not captured by the published literature. African regions show high planned/ongoing activities not fully represented in publications.

Key Conclusions

The assessment highlighted geographic disparities in data, emphasizing Africa as a region with many unreported or unpubUshed safety activities, suggesting the need for enhanced global collaboration and data accessibility to inform policy.