International – EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine

Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada collaboratively published the full clinical data reviewed as part of their authorisations of the Moderna COVID-19 vaccine.

This international partnership highlights the shared commitment of both organisations to ensure the public has as much information as possible to make decisions regarding vaccination. Increasing access to clinical data can also have widespread benefits for the health care system and the research community. EMA and Health Canada are the only two jurisdictions in the world publishing this comprehensive information.

“With the publication of the data package for Moderna’s COVID-19 vaccine, we are publishing the clinical reports that we assessed in support of the authorisation of this vaccine, and going forward, we will continue with this open data approach for all other COVID-19 vaccines,” said Emer Cooke, EMA’s Executive Director. “EMA and Health Canada’s joint commitment to openness and transparency will support global research, allow for public scrutiny and reinforce society’s trust in COVID-19 vaccines as mass vaccination campaigns continue to be rolled out across the EU, Canada and the rest of the world.”…