EMA, Health Canada Unveil Data Assessed in Moderna Vaccine Evaluation
The European Medicines Agency and Health Canada have both moved to publish the full clinical data they reviewed and found sufficient for authorizing Moderna’s COVID-19 vaccine.
The two regulators claimed that they are the first to publish the sprawling, complete set of clinical data Moderna submitted for its mRNA-based vaccine that won it authorizations in the EU, Canada, the U.S. and elsewhere.
“Openness and transparency are key to building confidence in COVID-19 vaccines,” the regulators said. “This … highlights the shared commitment of both organizations 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 healthcare system and the research community.”