mRNA-1273-P911: Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107257
• EU PAS number:
  EUPAS107256
• Study ID:
  107257
• Official title and acronym:
  mRNA-1273-P911: Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational cohort study that combines data collected directly from healthcare providers (HCP) with existing retrospective real-world data as captured in clinical electronic health record (EHR) and administrative claims data. Vaccine exposure and case identification information will be obtained retrospectively from existing real-world data to identify cases of post-vaccine myocarditis (PVM) and ultimately vaccine-associated myocarditis (VAM) for potential study inclusion. Eligible participants will be identified and followed for up to 5 years until the end of the study period or loss to follow-up or death.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 21/09/2022

Study start date

Actual: 30/04/2022

Data analysis start date

Actual: 31/10/2022

Date of interim report, if expected

Actual: 31/10/2022

Date of final study report

Planned: 31/10/2028

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)?:
  EU RMP category 3 (required)