Module 9 2021

Why have we come here?

Hazards of biologicals

• Ten children die in 1901 St Louis diphtheria epidemic tragedy – Tainted diphtheria 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 diphtheria toxoid

The Organisation for Professionals in Regulatory Affairs

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Hazards of blood products

• 1980s: HIV infected donated blood

• 1991: HAV from Factor VIII

– Solvent detergent treatment inadequate

• In 2,772 male US haemophilia patients – 30% +ve for HBV – 64% +ve for HCV

• 1993/4: HCV from co-fractionated IVIG

• 1994: HBV from pasteurised prothrombin concentrate

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

The Organisation for Professionals in Regulatory Affairs

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