Details:

Alternative Title:
Emerg Infect Dis
Personal Author:
Rosenthal, S. R. ; Merchlinsky, M. ; Kleppinger, C. ; Goldenthal, K. L. ;
Rosenthal, S. R. ; Merchlinsky, M. ; Kleppinger, C. ; Goldenthal, K. L. ; Less -
Description:
New stockpiles of smallpox vaccine are required as a contingency for protecting civilian and military personnel against deliberate dissemination of smallpox virus by terrorists or unfriendly governments. The smallpox vaccine in the current stockpile consists of a live animal poxvirus (Vaccinia virus [VACV]) that was grown on the skin of calves. Because of potential issues with controlling this earlier manufacturing process, which included scraping VACV lesions from calfskin, new vaccines are being developed and manufactured by using viral propagation on well-characterized cell substrates. We describe, from a regulatory perspective, the various strains of VACV, the adverse events associated with calf lymph-propagated smallpox vaccine, the issues regarding selection and use of cell substrates for vaccine production, and the issues involved in demonstrating evidence of safety and efficacy.
Subject:
[+]
Animals
Cell Line
Clinical Trials As Topic
Drug Design
Forecasting
Humans
Research Article
Smallpox
Smallpox Vaccine
Variola Virus

Source:
Emerg Infect Dis. 7(6):920-926. ;
Document Type:
Journal Article ;
Collection(s):
Emerging Infectious Diseases
Main Document Checksum:
[+]
urn:sha256:64d1294cc756d0f048ead04bff5b660c512a3a7b600e98eb61dbeb5ec318dde7
File Type:

Supporting Files

• 	11747717.nxml	txt
  	license.txt	txt

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