Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity (COVID-19)

Study identification

• EU PAS number:
  EUPAS41392
• Study ID:
  42014
• Official title and acronym:
  Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity (COVID-19)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Finland

  Germany

  Italy

  United States
• Study description:
  The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 24/05/2021

Study start date

Actual: 07/07/2021

Date of final study report

Planned: 30/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Moderna

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)