Format

Send to

Choose Destination
Emerg Infect Dis. 2001 Nov-Dec;7(6):920-6.

Developing new smallpox vaccines.

Author information

1
CBER/Food and Drug Administration, Rockville, MD 20852, USA. rosenthals@cber.fda.gov

Abstract

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.

PMID:
11747717
PMCID:
PMC2631916
DOI:
10.3201/eid0706.010602
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for CDC-NCEZID Icon for PubMed Central
Loading ...
Support Center