Moderna mRNA-1273 Observational Pregnancy Outcome Study (COVID-19)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48937
• EU PAS number:
  EUPAS41463
• Study ID:
  48937
• Official title and acronym:
  Moderna mRNA-1273 Observational Pregnancy Outcome Study (COVID-19)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• 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

Planned: 22/07/2021

Actual: 01/09/2021

Date of final study report

Planned: 06/01/2024

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)