Details:

Alternative Title:
Vaccine
Publisher's site:
http://dx.doi.org/10.1016/j.vaccine.2016.02.015
Personal Author:
Klug, Bettina ; Robertson, James S. ; Condit, Richard C. ; Seligman, Stephen J. ; Laderoute, Marian P. ; ... More +
Klug, Bettina ; Robertson, James S. ; Condit, Richard C. ; Seligman, Stephen J. ; Laderoute, Marian P. ; Sheets, Rebecca ; Williamson, Anna-Lise ; Chapman, Louisa ; Carbery, Baevin ; Mac, Lisa M. ; Chen, Robert T. Less -
Corporate Authors:
For The Brighton Collaboration Viral Vaccine Vector Safety Working Group
Description:
Vaccines are one of the most effective public health medicinal products with an excellent safety record. As vaccines are produced using biological materials, there is a need to safeguard against potential contamination with adventitious agents. Adventitious agents could be inadvertently introduced into a vaccine through starting materials used for production. Therefore, extensive testing has been recommended at specific stages of vaccine manufacture to demonstrate the absence of adventitious agents. Additionally, the incorporation of viral clearance steps in the manufacturing process can aid in reducing the risk of adventitious agent contamination. However, for live viral vaccines, aside from possible purification of the virus or vector, extensive adventitious agent clearance may not be feasible. In the event that an adventitious agent is detected in a vaccine, it is important to determine its origin, evaluate its potential for human infection and pathology, and discern which batches of vaccine may have been affected in order to take risk mitigation action. To achieve this, it is necessary to have archived samples of the vaccine and ancillary components, ideally from developmental through to current batches, as well as samples of the biological materials used in the manufacture of the vaccine, since these are the most likely sources of an adventitious agent. The need for formal guidance on such vaccine sample archiving has been recognized but not fulfilled. We summarize in this paper several prior major cases of vaccine contamination with adventitious agents and provide points for consideration on sample archiving of live recombinant viral vector vaccines for use in humans.
Subjects:
[+]
Animals Article Drug Contamination Humans Preservation, Biological Technology, Pharmaceutical Vaccines, Attenuated Viral Vaccines Virus Cultivation
Source:
Vaccine. 34(51):6617-6625
Pubmed ID:
27317264
Pubmed Central ID:
PMC5130882
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHSUnited States/
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:abdea80bbe860d2fdcd80326b8fcc6937278bad7caaebd1493100643b42827c2
Download URL:
https://stacks.cdc.gov/view/cdc/43192/cdc_43192_DS1.pdf
File Type:

Supporting Files

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