Moderna Spikevax® Studies
Moderna Spikevax® Studies
Moderna Spikevax® Studies
The Moderna Post-Authorization Safety Study (PASS) began in 2021 and 2022 with the aim of studying the safety of the Moderna Spikevax® vaccine. Separate, focused analyses have also been requested by the PRAC, for pregnancy outcomes as well as myocarditis and pericarditis following the administration of Spikevax, characterizing the history, course, outcomes, and risk factors.
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Registration and Protocols |
| EUPAS44273. Toft Sørensen H et al. Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe. 27 September 2021. |
| EUPAS105009. Ong D et al. Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2. |
| EUPAS44450. Toft Sørensen H et al. Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19). 27 September 2021. |