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Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
News: EMA starts rolling review of the Sputnik V COVID-19 vaccine
Last updated: 04/03/2021
EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine1 developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH.
The CHMP’s decision to start the rolling review is based on results from laboratory studies and clinical studies in adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19.
EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application.
EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality…
News: EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
Last updated: 02/03/2021
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.”…