Post-marketing safety of the Moderna COVID-19 vaccine following the 2024/2025 strain change in the United States

22/08/2025
29/09/2025
EU PAS number:
EUPAS1000000711
Study
Finalised

ENCePP Code of conduct

Yes
Data sources

Data source(s), other

​​Optum de-identified Clinformatics® Data Mart Database (Optum® CDM)Humana Healthcare Research Standard De-Identified Dataset​

Data sources (types)

Drug prescriptions
Electronic healthcare records (EHR)
Non-interventional study
Other
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Yes

Check completeness

Yes

Check stability

Yes

Check logical consistency

Yes
Data characterisation

Data characterisation conducted

Yes

Data characterisation moment

after data extraction