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inspections, must continue as long as the manufacturer holds a license
for the product. If requested by the FDA, manufacturers are required
to submit to the FDA the results of their own tests for potency, safety,
and purity for each vaccine lot. They may also be required to submit
samples of each vaccine lot to the FDA for testing. However, if the
sponsor describes an alternative procedure which provides continued
assurance of safety, purity and potency, CBER may determine
that routine submission of lot release protocols (showing results of
applicable tests) and samples is not necessary.
Until a vaccine is given to the general population, all potential
adverse events cannot be anticipated. Thus, many vaccines undergo
Phase 4 studies-formal studies on a vaccine once it is on the market.
Also, the government relies on the Vaccine Adverse Event Reporting
System (VAERS) to identify problems after marketing begins. The
VAERS system and how it works is discussed further on this website.

References
* National Vaccine Advisory Committee. " United States Vaccine Research:
A Delicate Fabric of Public and Private Collaboration. " Pediatrics, Vol
100(6), Dec.1997, pp. 1015-1020.
* Parkman PD, Hardegree MC. " Regulation and Testing of Vaccines. " In
Plotkin SA, Orenstein WA, [eds.]. Vaccines, 3d ed. Philadelphia:
Saunders; 1999, pp.1131-1143.
* Stehlin, Isadora. " How FDA Works to Ensure Vaccine Safety. " FDA
Consumer Magazine, March 1996.

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York County Medicine Winter 2020

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