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Posted 02 March 2021 | By Kari Oakes 

EMA, Health Canada publish Moderna data package

2789 Making good on an earlier commitment to transparency in regulatory decision-making during the COVID-19 pandemic, the European Medicines Agency (EMA), in collaboration with Health Canada, has published the full clinical data package upon which the regulators based their approvals of the COVID-19 vaccine jointly developed by Moderna and the US National Institutes of Health.
The Tuesday announcement of the availability of the data package “highlights the shared commitment of both organizations to ensure the public has as much information as possible to make decisions regarding vaccination,” according to EMA. (RELATED: EMA outlines regulatory transparency measures amid COVID pandemic, Regulatory Focus 30 October 2020)
“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 authorization 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, according to the press release, expects to be able to publish the clinical data supporting the conditional marketing authorization for the Pfizer-BioNTech COVID-19 vaccine “shortly.”
The promised publication of the full clinical data is part of a suite of transparency measures EMA undertook at the start of the COVID-19 pandemic. These measures include listing medicines whose sponsors have sought scientific advice from the COVID-19 Emergency Task Force and posting the full body of risk management plans, rather than just summaries, for COVID-19 vaccines and therapeutics.
EMA also has committed to issuing a news announcement by the day after a vaccine or therapeutic is taken up by the agency’s human medicines committee (CHMP) for rolling review, or when an application for extension of indication is filed. The agency is also issuing monthly safety updates for COVID-19 vaccines.
Other notifications are issued more rapidly and frequently for COVID-related medicines. Examples include speedier publication of European public assessment reports (EPARs) and publication of product information within one day of a positive CHMP opinion in English, with publication in other languages accompanying the accelerated EPAR notification.
EMA had previously been the victim of a cyberattack that “unlawfully accessed documents related to COVID-19 medicines and vaccines,” some of which were leaked to the internet. In a 15 January update, EMA noted that “Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.” (RELATED: Updated: Documents leaked to the internet in wake of EMA cyberattack, Regulatory Focus 12 January 2020)
After completing a registration form, individuals can view the clinical data on EMA’s clinical data webpage. Health Canada’s website also has posted the clinical data supporting its 23 December 2020 favorable decision to authorize the Moderna vaccine with conditions.
Available data include interim efficacy and safety data for three clinical trials, as well as a data anonymization report that details how the regulators protected personally identifying information while publicly releasing trial data.
“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, in the joint press release.


© 2022 Regulatory Affairs Professionals Society.

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