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The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.
The European Medicines Agency announced on March 2, 2021 that, in collaboration with Health Canada, it has published the full clinical data set that was reviewed as part of the authorization of the Moderna COVID-19 vaccine. Publication of data is part of EMA’s efforts to be transparent in its authorization of COVID-19 vaccines.
“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, in a press release. “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.”
The published data are available on EMA’s clinical data website and Health Canada’s Public Release of Clinical Information portal. EMA stated that clinical data for the Pfizer-BioNTech vaccine will be published soon.