Vaccines

Vaccines undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness or possible side effects.

Vaccine Product Approval Process

Vaccine clinical development follows the same general pathway as for drugs and other biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA.

Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic:

Phase 1 (initial human studies): safety and immunogenicity studies performed in a small number of closely monitored subjects.
Phase 2 studies: dose-ranging studies, may enroll hundreds of subjects.
Phase 3 trials: typically enroll thousands of individuals, provide critical documentation of effectiveness and important additional safety data required for licensing.

Biologics License Applications Process

After the completion of all three phases of clinical development, a Biologics License Application (BLA) is submitted.

The BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. A BLA is submitted by any legal person or entity that is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. The requirements for a BLA include:

Applicant information
Product/Manufacturing information
Pre-clinical studies
Clinical studies
Labeling

More information available at:
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/default.htm