Sunday, November 8, 2009

Requirements for a Vaccine Approval by FDA

Vaccine research, development and approval is a process that requires, time, is costly and is complex.
Approval Requirements:
  • Successful review of the BLA for a new indication from FDA
  • Successful review of the BLA for a new indication from VRBPAC
  • An adequate product label
  • Benefit/Risk Statement
  • Safe delivery of the vaccine to the public.
After approval of the license, monitoring of the product, production and announced and unannounced manufacturing facility inspections must continue as long as the manufacturer holds the license for the product.
Periodic Inspections (especially for a newly approved BLA license and manufacturer) will include tests for:
  • potency
  • safety
  • purity
  • submission of samples from each lot
  • continued quality control documentation
  • continued quality assurance documentation.
After a period of successful test results, FDA CBER, may determine that lot to lot samples are not necessary. FDA CBER may determine that an alternative procedure is acceptable instead of lot to lot sampling. Lot release protocols showing results of applicable tests for example can be submitted instead. The change from one procedure to another must be in writing and documented with the manufacturer, FDA CBER, and the pharma sponsor. The change will only be granted after a long period of successful routine testing of lot to lot samples.

What's next?

Potential adverse events (AEs) cannot be anticipated, therefore there "will be" a committed Phase 4 pharmacovigilance program as well as VAERS, a Vaccine Adverse Event Reporting System to identify problems after marketing begins. Who is responsible for any problems, manufacturing, safety, AE or otherwise ? - the pharma sponsor. Monitor the Phase 4 program, monitor safety, monitor AE Reports, monitor the Phase 4 monitors, monitor manufacturing, monitor quality.

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