A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States

ENCePP Code of conduct

No

Data sources

• Data source(s), other:
  5 data research partners, including data from 4 national insurers (CVS Health/Aetna, Carelon Research [formerly HealthCore/Anthem], Humana, and Optum) and 1 regional insurer (HealthPartners). Each data research partner is a participant in the FDA Sentinel System.
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No