Module 9 2024

03/09/2024

Why have we come here?

Hazards of biological

• 13 children die in 1901 St Louis diptheria epidemic tragedy

– Tainted diptheria antitoxin serum produced from horses.

– Traced to C.tetani infection in one horse

• 207 children in 1930 Lubeck incident contract TB (72 deaths)

– BCG substitution with virulent strain

• 600 children infected in 1948 Kyoto-shimane tragedy (84 deaths)

– Incompletely detoxified diptheria toxoid

The Organisation for Professionals in Regulatory Affairs

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Hazard of blood products – Virus Safety

1980s: HIV infected donated blood

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• 1980s/90s – In 2,772 male US heamophilia patients

– 30 % +ve for HBC

– 64 % +ve for HCV

1990: HAV from Factor VIII

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– Solvent detergent treatment inadequate, difficult to eradicate (non-enveloped)

– >80 cases 1991

– Clusters of infection into the late 90’s e.g. in Germany in 1997

• 2001: product withdrawals from donors exposed to tick-borne pathogens

The Organisation for Professionals in Regulatory Affairs

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