Protocol

An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States

November 21, 2022
Authors:

Harvard Pilgrim Health Care Institute, RTI Health Solutions, CVS Health, Carelon Research, Humana HealthCare Research, Optum Epidemiology, Johnson & Johnson

Capability:
Multi-Site Methods & Coordination
Expertise:
Regulatory Research & Support
RWE Research & Consulting
View the public protocol

Johnson & Johnson, Harvard Pilgrim Health Care Institute, RTI Health Solutions, CVS Health, Carelon Research, Humana HealthCare Research, Optum Epidemiology. An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States (EUPAS49836; Study ID 49837; VAC31518COV4001). Amsterdam: European Medicines Agency (EMA); 2022 Nov 21. Available from: https://catalogues.ema.europa.eu/node/3477/administrative-details