Vaccines

Center for Biologics Evaluation and Research (CBER) regulates vaccine products. 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. 

The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. 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. [1]

Vaccine Product Approval Process

Vaccine clinical development follows the same general pathway as drugs and other biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug (IND) Application to the US Food & Drug Administration.[2] (can probably remove this link all together, it doesn’t work but doesn’t seem to be needed either)

The sponsor of a new vaccine product follows a multi-step approval process, which typically includes: [3]

Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed. To learn more about the FDA’s role in the vaccine approval process, refer to the FDA’s Vaccine Product Approval Process web page. To learn more about the FDA’s vaccine notices and rules, refer to the FDA’s Vaccine Notices, Proposed and Final Rules web page. (neither of these two vaccine links work, I’m not sure what the proper alternative links would be)

Biologics License Application Process

After the completion of all three phases of clinical development, a Biologics License Application is submitted. The BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. 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 may submit a BLA. The requirements for a BLA include:[4]

  • Applicant information
  • Product/manufacturing information
  • Pre-clinical studies
  • Clinical studies.

Updated by Peter Matos, December 2023