EMA, Health Canada Publish Full Moderna COVID-19 Vaccine Filing Support Data

Date: March 4, 2021 | Country: CANADA-ONTARIONETHERLANDS | Region: EUROPENORTH AMERICA | Type: Regulation | Keywords: #ema #healthcanada #moderna #transparency #vaccine

PRICENTRIC BRIEF:

  • The European Medicines Agency (EMA) and Health Canada have jointly published the full clinical data package submitted to the regulators by Moderna and the US National Institutes of Health when submitting for approval of their COVID-19 vaccine
  • The move is part of an earlier commitment to transparency in regulatory decision-making during the pandemic, as last October the EMA re-affirmed its commitment to independence and transparency in evaluating treatments and vaccines for COVID-19
  • “Going forward, we will continue with this open data approach for all other COVID-19 vaccines,” said Emer Cooke, EMA’s Executive Director

 

THE DETAILS

AMSTERDAM, The Netherlands – The European Medicines Agency (EMA) and Health Canada have jointly published the full clinical data package submitted to the regulators by Moderna and the US National Institutes of Health when submitting for approval of their COVID-19 vaccine.

The move is part of an earlier commitment to transparency in regulatory decision-making during the pandemic, as last October the EMA re-affirmed its commitment to independence and transparency in evaluating treatments and vaccines for COVID-19.

“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.

He continued, “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.”

Last year the EMA promised to uphold the same rigor and diligence it applies when reviewing all medicines while tackling COVID-19 treatments during this crisis.

As noted by EMA, its “tried and tested measures” make sure EMA’s recommendations are driven solely by science and public health needs, and not by other “interests.”

The letter also lays out EMA’s transparency plans, outlining the agency’s intent to publish clinical data backing its recommendation for any COVID-19 treatment. EMA also reinstated its policy on the proactive publications of clinical data exclusively for COVID-19 medicines, as it was suspended when EMA relocated from London to Amsterdam.

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