FDA Vaccine Product Approval Process

“The introduction of a safe and effective COVID-19 vaccine is an essential element in ending this devastating global pandemic. Both physicians and the public must have confidence that efforts to speed vaccine development have not interfered with a thorough, evidence-based review of vaccine candidates or standards for safety and efficacy.” Susan R. Bailey, MD, President of the American Medical Association

Excerpted from, We must be able to trust the FDA vaccine approval process

There are three phases of vaccine development

Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic. Initial human studies, referred to as Phase 1, are safety and immunogenicity studies performed in a small number of closely monitored subjects.

Phase 2 studies are dose-ranging studies and may enroll hundreds of subjects. Finally,

Phase 3 trials typically enroll thousands of individuals and provide the critical documentation of effectiveness and important additional safety data required for licensing. At any stage of the clinical or animal studies, if data raise significant concerns about either safety or effectiveness, FDA may request additional information or studies, or may halt ongoing clinical studies.

If successful, the completion of all three phases of clinical development can be followed by the submission of a Biologics License Application (BLA). To be considered, the license application must provide the multidisciplinary FDA reviewer team (medical officers, microbiologists, chemists, biostatisticians, etc.) with the efficacy and safety information necessary to make a risk/benefit assessment and to recommend or oppose the approval of a vaccine. Also during this stage, the proposed manufacturing facility undergoes a pre-approval inspection during which production of the vaccine as it is in progress is examined in detail.

The complete process of vaccine approval with references is located on the FDA website. 

Click Here to Review the FDA Website

Leave a Comment

Your email address will not be published. Required fields are marked *

css.php Scroll to Top