Phases of Vaccine Development

Ask Dr. Jill

In this episode, Dr. Jill Waggoner discusses the various phases of vaccine development. Information to help explain the methods via which vaccines are developed and tested before being released to the public. This brief discussion gives the listener the information they need to understand how vaccines come into being.

Before vaccines are licensed by the FDA, they are tested extensively in the laboratory and with human volunteers to ensure their safety. First, researchers use computers to predict how the vaccine will interact with the human immune system. Then the vaccines are tested on animals including mice, guinea pigs, rabbits, and monkeys. Finally, the vaccines go into human trials.

Vaccine development and approval follows the same general steps that are used to test drugs and other biological agents. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA. The IND describes the vaccine, its method of manufacturing, and quality control tests for release. Also included are information about the vaccine’s safety and ability to elicit a protective immune response (immunogenicity) in animal testing, as well as a proposed plan for testing the drug on humans.

Dr. Jill Waggoner is a residency trained, board certified Family Practice Physician with nearly three decades of experience. She is located in the Dallas Fort Worth Metroplex holds a Medical Degree and a Master's Degree from the University of Oklahoma. She has certifications in both Preventive Medicine and Wellness Coordination from the prestigious Cooper Institute.

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