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 biologics review and approval functions, and oversees the Vaccine Adverse Event Reporting System (VAERS), which is utilized to gather risk data on vaccine products.¹

CDC

The Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Policy are also central to the work on new vaccines.

HRSA

The HHS Health Resources and Services Administration (HRSA) houses the National Vaccine Injury Compensation Program (VICP) created by the 1986 National Childhood Vaccine Injury Compensation Act and the Countermeasures Injury Compensation Program (CICP) created in the 2005 PREP Act.²

The HRSA regulations provide a table of covered vaccines and their potential adverse effects, for which, should they occur, patients may be compensated. VICP is the principal source of compensation payments to persons with very serious medical consequences from a covered vaccisicene; it has made more than 5,000 compensation payments since 1986 while the very restrictive CICP has made only twenty-nine payments in 2005-2021.

FDA's full process of approval for a vaccine is called a "biologics license," which is the equivalent of an approval of a new drug application (NDA) for a conventional drug product.³ For COVID-19 vaccines, FDA has utilized its power to provide temporary "Emergency Use Authorization" (EUA) on a product-specific basis. The FDA's Center for Biologics Evaluation and Research in a news release...