Project Grant NU38CK000485

ASSESSING THE SAFETY OF COVID-19 VACCINES ACROSS LARGE AND DIVERSE POPULATIONS USING THE 17-COUNTRY GLOBAL VACCINE DATA NETWORK CONSORTIUM - GLOBALLY, SCIENTISTS HAVE RESPONDED WITH UNPRECEDENTED EFFORT TO DEVELOP COVID-19 VACCINES. THE AVAILABILITY OF MULTIPLE VACCINES WITH THE POTENTIAL TO VACCINATE BILLIONS OF PEOPLE IS PLACING TREMENDOUS STRESS ON POST INTRODUCTION VACCINE SAFETY PHARMACOVIGILANCE SYSTEMS. THERE IS AN URGENT NEED TO BE ABLE TO ASSESS AND COMPARE THE SAFETY OF THESE VACCINES TO ASSURE THAT VACCINES ARE SAFE AND EFFECTIVE. THE GLOBAL VACCINE DATA NETWORK (GVDN), ESTABLISHED IN 2019 AS A NETWORK OF 21 SITES IN 17 COUNTRIES AND 5 WHO REGIONS, HAS THE CAPABILITY AND CAPACITY TO UNDERTAKE COLLABORATIVE ACTIVE POST INTRODUCTION PHARMACOVIGILANCE VACCINE SAFETY STUDIES FOR COVID-19 VACCINES USING CLINICAL DATABASES, EITHER INDEPENDENTLY OR AS COLLABORATORS. IN THIS PROPOSAL, GVDN DETAILS HOW WE WILL DEVELOP AND ADAPT PROTOCOLS FOR ASSESSING BACKGROUND RATES OF ADVERSE EVENTS AS WELL AS DESCRIBING HOW WE WILL PERFORM STUDIES TO ASSESS THE SAFETY OF THE AVAILABLE VACCINES USING ELECTRONIC HEALTH CARE DATA. THIS WILL INCLUDE CASE-BASED AND COHORT STUDIES AND RAPID CYCLE AND TREE SCAN SIGNAL DETECTION STUDIES AT SOME SITES. THESE STUDIES WILL ALL BE PERFORMED WITH A COMMON PROTOCOL TO BE ENABLE RESULTS TO BE COMBINED, AND ALSO TO ENABLE COMPARISON OF RESULTS BETWEEN VACCINES AND VACCINE PLATFORMS. WE WILL ADAPT AND DEVELOP PROTOCOLS TO ALLOW NATIONAL AND/OR REGIONAL ACTIVE POST INTRODUCTION PHARMACOVIGILANCE PROGRAMS TO CONTRIBUTE TO A GLOBAL COLLABORATIVE EFFORT.