Module 9 2021

Two centuries ago

Edward Jenner, 14 May 1796

• Pustular material from cowpox lesion (Sarah Nelms, a milk maid)

• Inoculated 8 year old boy (James Phipps)

• Boy inoculated with smallpox 6 weeks later

• No infection occurred

If Jenner’s clinical trial and investigation product had been constrained by a competent authorities and ethical oversight, would vaccines have started here?

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One century ago

• Further vaccines: rabies (Pasteur, 1885), cholera (1892), typhoid (1898), tuberculosis (1921), pertussis (1923), (mumps (1949), polio (1954), etc .

• Antitoxins: diphtheria (1894), tetanus (1927)

• Blood products: plasma fractions (Cohn), serum albumin for shock WW2, insulin (Banting & Best 1923

• Antibiotics: penicillin (Fleming 1928), started in 1939

The Organisation for Professionals in Regulatory Affairs

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