Expected, but still good #covid19 vaccine news for Europe: @EMA_News has now moved up the likely date for Moderna vaccine as well. Meeting now scheduled for January 6 instead of January 12. Means vaccination with second vaccine likely to start a week earlier than thought in EU.
@EMA_News "Today, ahead of schedule, the company has submitted the last outstanding data package needed for the assessment of the application. This contains information that is specific to the manufacturing of the vaccine for the EU market“, says EMA press release.
@EMA_News "The number of infections is increasing across Europe and we are aware of the huge responsibility we have to get a vaccine to the market as quickly as is feasible, whilst maintaining the robustness of our scientific review”, EMA head Emer Cooke says in the press release.
@EMA_News Also spells out what marketing authorisation includes:
- full prescribing information and package leaflet for safe use
- risk-management and safety monitoring plan
- manufacturing controls
- investigation plan for use in children
-legally binding post-approval obligations
- full prescribing information and package leaflet for safe use
- risk-management and safety monitoring plan
- manufacturing controls
- investigation plan for use in children
-legally binding post-approval obligations
• • •
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