Once a vaccine is ready for market, a company must adhere to continuing manufacturing, reporting, inspection, and other requirements. The sponsor company must also scale up production in preparation for widespread distribution and ensure that components and other materials used in the manufacturing process are readily available. Lastly, the vaccine must be distributed, stored, and administered to the population. This session will describe the different requirements at play, utilizing COVID-19 vaccine-related practical examples and considerations.
- Establishment Registration and Listing
- Manufacturing Standards
- Scaling Up
- Post-Approval Changes
- Use of Defense Production Act for COVID-19 Vaccine Manufacturing
- Distribution, Storage, and Supply Chain Issues
- Determining Priority Populations
- Encouraging Vaccine Administration
Kathleen M. Sanzo, Partner, Morgan, Lewis & Bockius LLP
This session was recorded as part of FDLI’s Virtual Fundamentals of Vaccine Regulation Course in February 2021.