Module 9 2021
Smallpox vaccine manufacture 1891
• “A red heifer calf about two months old, in good flesh and health, is placed upon a bench in a special operating room and strapped on its side with one hind leg fastened vertically against the back of the bench. The area between the thighs, covering about ten inches square and including the teats, is shaved and washed with soap and water, with hydrogen peroxide solution, and finally with sterilized water and then dried with sterilized absorbent cotton. On the area so prepared, one hundred spots are then scarified, each from a quarter to half an inch square. The blood is washed away with sterilized water, and when the bleeding has entirely ceased virus is rubbed on each spot very thoroughly for some minutes; the calf is then returned to its stall. It is examined on the third and following days, and when the vesicles are seen to be at the proper stage of development, which is usually on the sixth day, the calf is again placed upon the bench and the whole shaved area washed twice with sterilized water and once again with peroxide of hydrogen solution. All macroscopic dirt and crust is removed and every scarification is cleansed as thoroughly as possible; then with a sterilized curette each scarification is scraped and every particle of pulp removed into a sterilized glass dish. The pulp taken is weighed, comminuted, and mixed with a measured amount of chemically pure glycerin*, by being passed between glass rollers on which the glycerin flows. There is thus produced a brown syrupy homogeneous emulsion, which is then drawn by a filter pump into sterilized glass tubes, which when full are sealed in a flame at both ends. Each of these tubes holds about 20 cubic centimeters.”
•
* glycerin acted as a preservative
The Organisation for Professionals in Regulatory Affairs
5
Where have we come from?
• A dangerous past, with an uncertain future
• Historical use of biological systems to our individual and collective benefit
• Total absence of oversight or control
• Clinical knowledge advanced faster than the development of prevention or cure
• The scientific method was new
The Organisation for Professionals in Regulatory Affairs
6
3
Made with FlippingBook Learn more on our blog