EMA and Health Canada to make COVID-19 vaccine data open access

The European Medicines Agency (EMA) and Health Canada have collaboratively published the full clinical data reviewed as part of their authorisations for the COVID-19 Vaccine Moderna. The aim is to increase trust in the vaccine by ensuring the public has as much information as possible to make decisions regarding vaccination.

EMA stated that in addition to driving consumer trust, this open access approach to clinical data could also have widespread benefits for the health care system and the research community. These two regulators are the only ones in the world publishing this information.

Emer Cooke, EMA’s Executive Director, revealed that the publication of the Moderna data is just the start of the project: “going forward, we will continue with this open data approach for all other COVID-19 vaccines.” Adding: “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.

The two regulatory bodies revealed that they are also working together with other manufacturers to expedite the publication of the 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 clinical data package for the COVID-19 Vaccine Moderna, 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.