Module 9 2021

23/03/2021

Why are vaccines different? Considerations for registration….

Usually administered to very large numbers of healthy people , often infants, in national immunization programs; thus safety and quality are paramount *

• Biological, and thus inherently variable, nature of the products themselves • The raw materials used in their production • Biological methods used to test them • Range of different technologies used • Often combinations

Resulting in the licensure and commercialization of a product that has been demonstrated to be acceptably safe and effective and that can be manufactured in a consistent manner

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What are the requirements?

 Licensed vaccines must be*:  Safe ….well tolerated…: “relatively free from harmful effect … when prudently administered, taking into account the character of the product in relation to the condition of the recipient at the time.”  Pure: “relatively free from extraneous matter in the finished product,…”  Potent: “specific ability of the product … to effect a given result.”  Manufactured consistently according to current Good Manufacturing Practices  … and ideally, registered as quickly as possible in order to be made available to people who need them * Regulatory Considerations for the Manufacture of Investigational Vaccines for Clinical Trials Jon R. Daugherty “Office of Vaccines Research and Review NIAID Regulatory Course 30th October 2007

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