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VaxLaw: Vaccine Law

Content:

  1. WHO vaccine regulation
  2. Vaccine product approval process at USA
  3. Vaccine safety
  4. More vaccine laws

WHO Vaccine Regulation:

Vaccine Product Approval Process at USA:

     The Center for Biologics Evaluation and Research (CBER) at the USA Food and Drug Administration (FDA) is responsible for regulating vaccines in the United States. Basically, Vaccine clinical development follows the same general pathway as for drugs and other biologics.

     A sponsor need first need to submit an Investigational New Drug application (IND) to FDA before any clinical trials with a vaccine. Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, the same for for any drug or biologic. At any stage of the clinical trials, FDA may request additional information or studies, or halt ongoing clinical studies if necessary.

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

     If successful, a Biologics License Application (BLA) can be submitted. A pre-approval inspection of the proposed manufacturing facility will be under way during this stage. FDA will review a license application. The sponsor and the FDA may present their findings to FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee provides advice to the FDA regarding the safety and efficacy of the vaccine.

     The FDA will continue to oversee the production of vaccines even after the vaccine is licensed. If requested by the FDA, manufacturers are required to submit the results of their own vaccine tests and even vaccine samples to the FDA.

     Phase 4 studies: formal studies on a vaccine once it is on the market. It is because all potential adverse events cannot be anticipated until a vaccine is given to the general population. The Vaccine Adverse Event Reporting System (VAERS) will also be used to identify problems after marketing begins.

     Reference and More Detail: Vaccine Product Approval Process at USA

Vaccine Safety:

More Vaccine Laws: