Coronavirus Notebook: EMA Data Hack Aimed At 'Undermining Trust' In Vaccines, Russia Plans EU Sputnik V Filing Next Month
Executive Summary
France has reported on side-effect reports concerning the Pfizer/BioNTech vaccine, and the World Health Organization has warned that plans to provide global equitable access to coronavirus vaccines are at risk.
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The team behind Russia’s first COVID-19 vaccine has asked for scientific advice from EU drug regulators in view of a possible submission for marketing authorization.
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Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.
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