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.”
“Health Canada is committed to openness and transparency. By releasing the clinical data behind the Moderna COVID-19 vaccine submission, Canada and EMA are providing the healthcare community and researchers with a tremendous resource they can use to help bring the COVID-19 pandemic under control,” said Pierre Sabourin, Assistant Deputy Minister of Health Canada.
EMA and Health Canada are working together with manufacturers to expedite the publication of clinical information underpinning their authorisations for medicines and vaccines for COVID-19. The clinical data for the Pfizer-BioNTech COVID-19 vaccine is expected to be published shortly.
The publication of clinical data for these vaccines is part of the exceptional measures taken by EMA, and the commitments made by Health Canada, to maximise the transparency of regulatory activities on treatments and vaccines for COVID-19 that are authorised or under evaluation. It is in line with EMA’s landmark policy launched in 2016 to proactively publish clinical data supporting marketing authorisation applications, and Health Canada’s clinical transparency initiative which followed in 2019.
The clinical data package for the Moderna COVID-19 vaccine, presenting the interim safety and efficacy data generated in three clinical studies, is available on EMA's clinical data website and Health Canada’s Public Release of Clinical Information portal.
The data anonymization report is also part of the data package. It provides an explanation of the methods used to protect personal data in the clinical reports.