Bavarian Nordic Receives U.S. and EU Approvals of its Fill and Finish Vaccine Manufacturing Facility
An expedited pre-approval inspection (PAI) was conducted by the U.S. Food and Drug Administration (FDA) at the facility at the beginning of July 2022.
- An expedited pre-approval inspection (PAI) was conducted by the U.S. Food and Drug Administration (FDA) at the facility at the beginning of July 2022.
- The inspection included the final drug production of JYNNEOS, which was previously performed at a contract manufacturer.
- The inspection was successfully completed with no observations made, which has led to the approval of Bavarian Nordic as the new drug product manufacturer of JYNNEOS.
- Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines.