Emergency Use Authorisation
The Emergency Use Authorisation allows the simultaneous testing and mass production of vaccines, drugs or other products. It is granted only during the emergency declarations. The EUA is permitted to be used based on the best available evidence rather than relying on concrete evidence that is based on long-term testing. It is used to assess the risks and benefits associated with the product.
For EUA of the COVID-19 vaccines, the FDA required at least 2 months of safety data for at least 3,000 people in the clinical trials. This data should include information about serious adverse events caused by the vaccines.