COVID-19 was a key priority for EMA in 2021: The Agency recommended four vaccines and five treatments for COVID-19. A lot of effort was dedicated to scaling up vaccine manufacturing capacity and supply. Throughout the year, EMA approved 33 new manufacturing sites for COVID-19 vaccines, leading to a substantial increase in vaccine manufacturing capacity and supply.
Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable recommendations, including safety recommendations for COVID-19 vaccines that received global public attention, is also included in the document.
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Human medicines highlights 2021 (PDF/1.17 MB)