CHAPTER 14

• Jurisdiction: United States

CHAPTER 14 WHAT IS THE REGULATORY PROCESS FOR VACCINES?

The U.S. Department of Health and Human Services (HHS) has multiple roles in dealing with vaccines: developer, funder, supporter, reviewer, and public interface, including its agencies NIH, BARDA, FDA, CDC, CICP, VICP, and VAERS that are described here. The Defense Department, State Department, Commerce Department, and other federal entities are also involved.

NIH

For most of the novel research on vaccines, the National Institutes of Health awards competitive grants to academic researchers. They study viral risks and potential vaccines using NIH funding.

BARDA

The Biomedical Advanced Research and Development Authority within the Department of Health and Human Services funds projects to develop and manufacture novel vaccines.

FDA

The Food and Drug Administration receives submissions of laboratory "preclinical" data and reviews applications for companies that wish to conduct research on human subjects with these vaccines. The Center for Biologics Evaluation and Research within the FDA manages the...