Nov. 2020
Joint statement to consolidate the pharmacovigilance systems for securing safety of theCOVID-19 vaccine products
issued by
Japanese Society for Pharmacoepidemiology
Japanese Epidemiological Association
Society for Clinical Epidemiology
The Japanese Society for Vaccinology

The challenge of emerging, life-threatening novel corona virus outbreak is the ongoing, global
public health crisis, affecting people’s life and society extensively. All-out battle by all the nationsof the world against COVID-19 virus entails every countermeasure including the existing publichealth, medical, and social interventions, however, it is expected that containment of COVID-19
pandemic and prevention of its resurgence would not be achievable without effective, brand-new
vaccines against novel corona virus and medical interventions for the infection. Such highexpectation of the public and substantial support of the national governments have prompted themedical and pharmaceutical communities to facilitate the development of multiple COVID-19
vaccines at unprecedented speed and we see a likelihood that those vaccine products become
available in the market within 2020. Vaccination program is a medical intervention to the wholesociety and needs tens of thousands of healthy people being vaccinated to be effectivelyimplemented. Therefore, it is essential that high standard of vaccine safety should be met forsuccessful implementation of vaccination programs. A safety issue of a COVID-19 vaccine, once itarises after the launch, itself could be greatly and extensively impactful to the whole society andenhance the public’s distrust of vaccine, potentially resulting in unsuccessful intervention.
Thus, we believe that the system securing the post-authorization safety of approved COVID-19vaccines be the most urgent issue to be addressed, regardless of following the precedent
frameworks of existing pharmacovigilance methods used for pharmaceutics and vaccines. The
proactive pharmacovigilance system of COVID-19 vaccine be established in advance incooperation and collaboration with vaccine suppliers, health authorities and the public by taking
full advantages of leading-edge social infrastructure, to capture safety concerns instantaneouslyand infallibly, and to implement real-time, proactive countermeasures against safety concerns
arising post-authorization. In addition, many vaccine products under development need multiple
shots and adherence to predefined vaccination schedule is essential for securing efficacy andsafety, and then the record sharing of vaccination among healthcare professionals is necessary.
To this end, it is an imperative to construct and operate the national registry to enroll and follow
all the vaccinees of approved COVID-19 vaccines, allowing collection of vaccination records andoutcome data after vaccination systematically.

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Thus, we PROPOSE that the following actions 1 -3 shall be taken;
1. Construct the online electronic registry system and mandate the entry of the vaccination
coupons of approved COVID-19 vaccines into the registry via the Internet at vaccination, toregister and follow all the vaccinees in a centralized manner. Vaccinee’s consent to the use of
the registry data and retrieval of relevant health records should be obtained on registration.
2. Allow linkage between the registry and various types of electronic health records (EHRs)
database such as claims and hospital administrative databases, to enable real-time andformal epidemiologic analyses by combining the health and social data with vaccination data
at individual level. Otherwise, incorporating or recording the data related to vaccination into
the claims database by any means should be sought where record linkage is impossible.
3. Utilize the clinical information obtained through the linkage of vaccine registry and EHR
databases for assessing causal inference between vaccination and an occurrence of healthhazards in a reported case, to provide quick remedy for and rational countermeasures against
potential adverse reactions due to vaccination.
To provide effective and safe vaccination to everyone is vital and locomotive to overcome thepandemic caused by this novel corona virus at the earliest possible time. We believe that it is a
MUST to consolidate the pharmacovigilance system of COVID-19 vaccines which enables theproactive and rapid data collection about emerging safety concerns in advance.

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