Moderna

This sponsor has funded 9 studies across 12 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
41392 Ongoing Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI)... No No
41463 Ongoing Moderna mRNA-1273 Observational Pregnancy Outcome Study (COVID-19) No No
42328 Ongoing Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe A contribution of COVIDRIVE, a public-private partnership to... Yes No
44273 Ongoing Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19) Yes No
44450 Ongoing Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19) Yes No
105009 Ongoing Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2. No No
106670 Ongoing mRNA-1273-P901, Real-World Study of the Effectiveness of Moderna COVID-19 Vaccine No No
106694 Ongoing mRNA-1273-P920, Post-marketing safety of elasomeran/davesomeran and andusomeran vaccines in the United States No No
107256 Ongoing mRNA-1273-P911: Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA) No No

PAS by Risk Management Plan (RMP) requirement

Moderna

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.