What happens after clinical trials are finished?

Once the clinical trials can demonstrate vaccine safety and effectiveness at an appropriate dose, the manufacturer applies to the FDA to license the vaccine so that it can be used in the general population.  The FDA reviews all of the data from the phased clinical studies using rigorous protocols and procedures.

The vaccine is not licensed or approved until the FDA can ensure the vaccine is safe and effective. In emergencies, such as the current COVID-19 pandemic, vaccines can also be authorized through an Emergency Use Authorization (EUA). The FDA usually authorizes an EUA for a specific population. After receiving an EUA, the manufacturer continues monitoring clinical trials as well as gathering and analyzing data. With more data, the manufacturer can then submit to the FDA for a Biologic License Application (BLA) so that the vaccine is able to be used more widely than originally covered in the EUA.

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