Abstract

Importance. The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns. This has caused vaccine hesitancy to be the top 10 in threats to global health. The comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval surveillance. It has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical trials.Highlights. In the present study, the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety concerns. Then, the global progress of active surveillance systems was reviewed, mainly focusing on population-based or hospital-based active surveillance. With these successful paradigms, the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases, methodology challenges, policy supports, and ethical considerations.Conclusion. In the inevitable trend of the global vaccine safety ecosystem, the establishment of an active surveillance system for vaccine safety in China is urgent and feasible. This process can be accelerated with the consensus and cooperation of regulatory departments, research institutions, and data owners.

Highlights

  • Vaccines are the most cost-effective measures to prevent and control a disease

  • The present study aims to review the examples of active surveillance worldwide and its main challenges, and raise more regulatory attention and scientific consensus, which in turn would accelerate the robust, responsive, and representative active monitoring in China

  • Due to the global increase in threats and challenges of vaccine hesitancy and inevitable vaccine inherently-related reactions, the determination of the appropriate and timely response to adverse events has played a critical role in immunization safety surveillance [18]

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Summary

Introduction

Vaccines are the most cost-effective measures to prevent and control a disease This can be the essential means for the global elimination or triumph of communicable diseases, such as the nearly eradicated poliovirus, the priority of cervical cancer [1], or the present threat of the corona virus disease 2019 (COVID-19) pandemic [2]. In 2019, vaccine hesitation, that is, the reluctance or refusal to be vaccinated, despite the availability of vaccines, has been named one of the top 10 threats to global health [5] This threatens to reverse the progress made for tackling vaccine-preventable diseases or is even associated with the resurgence of eradicated infectious diseases, such as the previous outbreak of measles and pertussis in America [6]. The present study aims to review the examples of active surveillance worldwide and its main challenges, and raise more regulatory attention and scientific consensus, which in turn would accelerate the robust, responsive, and representative active monitoring in China

The Necessity of Active Surveillance
Framework of the Immunization Safety Surveillance
Detection of the Vaccine Safety Signal
Verifying the Vaccine Safety Signal
Validation of the Vaccine Safety Signal
Disposing the Vaccine Safety Signal
Global Progress in Active Safety Surveillance
Potentiality of Active Safety Surveillance in China
Social and Ethical Considerations
Conclusion
Findings
Conflicts of Interest
Full Text
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