Unexpected inefficiency of the European pharmacopoeia sterility  test for detecting contamination in clostridial vaccines.
Three outbreaks of clostridial disease in ruminants were reported in Spain. Out of 202,525 animals in affected herds, 41,767 were infected and 22,189 died. Epidemiological investigation linked these outbreaks with vaccination with three different commercial anti-clostridial vaccines contaminated with Clostridium sordellii. Vaccines were produced by the same manufacturer. Microbiological and molecular genetic analyses confirmed this association, and isolates of C. sordellii with identical biochemical and pulsed-field gel electrophoresis (PFGE) macrorestriction patterns were isolated from both diseased animals and the epidemiologically related vaccines. Contamination of the commercial vaccines was not detected by the sterility test proposed by the European (EU) Pharmacopoeia. However, growth was obtained when the commercial vaccines were inoculated into specific culture media for Clostridium and incubated for up to 60 days.
Téllez
Sonia
S
Departamento de Sanidad Animal, Facultad de Veterinaria, Universidad Complutense, Avda. Puerta de Hierro, s/n, 28040 Madrid, Spain.
Casimiro
Ramiro
R
Vela
Ana I
AI
Fernández-Garayzábal
José Francisco
JF
Ezquerra
Remedios
R
Latre
María V
MV
Briones
Victor
V
Goyache
Joaquín
J
Bullido
Rosario
R
Arboix
Margarita
M
Domínguez
Lucas
L
D000818:Animals; D001428:Bacterial Vaccines / Q000382:microbiology* / Q000592:standards; D003015:Clostridium Infections / Q000662:veterinary*; D047989:Paraclostridium sordellii / Q000302:isolation & purification*; D004196:Disease Outbreaks / Q000662:veterinary; D004340:Drug Contamination; D016521:Electrophoresis, Gel, Pulsed-Field; D012418:Ruminants / Q000382:microbiology; D013030:Spain
D001428:Bacterial Vaccines