Study identification

EU PAS number

EUPAS1000000711

Study ID

1000000711

Official title and acronym

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

DARWIN EU® study

No

Study countries

United States

Study description

This retrospective US cohort study will actively monitor safety outcomes following administration of mRNA-1273.712 targeting the SARS-CoV-2 KP.2 variant among individuals in the US enrolled in commercial and Medicare Advantage plans.
The study will descriptively characterize the utilization of mRNA-1273.712 and inferentially assess the risk of myocarditis, pericarditis and other safety topics of interest in recipients of mRNA-1273.712.

Study status

Finalised
Research institutions and networks

Institutions

Aetion, Inc., a Datavant company

Contact details

Clinical Trial Disclosure ModernaTX

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

ModernaTX
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only