How to Strengthen China's Pharmacovigilance for SARS-CoV-2 Vaccines in Post-marketing Phase

doi:10.19803/j.1672-8629.2020.11.04

Abstract

Abstract: Objective To explore how timely find out the adverse events of specific interest following immunization, comprehensively evaluate the safety profile of vaccines and ensure the safety to recipients when SARS-CoV-2 vaccines are approved for marketing and inoculation to populations in the future. Methods Suggestions on strengthening pharmacovigilance are provided by review of World Health Organization's recommendations for pharmacovigilance preparedness for the launch of the COVID-19 vaccines, the standards and tools developed by the Brighton Collaboration through Safety Platform for Emergency vACcines and the analysis of China's pharmacovigilance surveillance systems. Results In view of unusual pathophysiology of COVID-19, innovative technology platform to accelerate development of SARS-CoV-2 vaccine candidates, and limited number of subject exposed, heterogeneity of population studies, and limited period of follow up during pre-licensure trials, it is critical to continue monitoring the safety of vaccine at the time of deployment to further characterize and quantify clinically relevant risks and to identify new reactions. Conclusion sIt is suggested that China urgently needs to develop a post-marketing monitoring plan for SARS-CoV-2 vaccines, layout resource to carry out active surveillance for vaccine safety and enhance passive surveillance for adverse events following immunization and adverse events of specific interests, strengthen authorities'information communication at all levels to reduce public hesitancy to vaccine.

Key words: COVID-19, vaccine safety, pharmacovigilance

CLC Number:

R951

ZUO Shuyan. How to Strengthen China's Pharmacovigilance for SARS-CoV-2 Vaccines in Post-marketing Phase[J]. Chinese Journal of Pharmacovigilance, 2020, 17(11): 766-772.

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https://zgywjj.magtechjournal.com/EN/Y2020/V17/I11/766

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