Complex Journey of a Vaccine: The Steps Behind Developing a New Vaccine

This report highlights factors that contribute to the lengthy development process of novel vaccines. It provides an overview of the vaccine development process, and explains how the current regulatory environment can significantly slow the process down due to challenges including the absence of clear guidelines or regulations for clinical trial requirements, the lack of a global standard among Clinical Trial Applications (CTA), and unpredictability of review timelines by countries. The report provides eight key recommendations that could speed up innovative vaccine development, particularly around regulatory CTA requirements and approvals.

Author: International Federation of Pharmaceutical Manufacturers & Associations

Published: 2019

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Resource types: Report

Diseases/vaccines: Not disease/vaccine specific

Topics: General information, Vaccine safety and performance

Regions: Global