Chat with AI
Microbiology 9th Edition by Laura Black, Jacquelyn Black
Edition 9ISBN: 9781118934753Microbiology 9th Edition by Laura Black, Jacquelyn Black
Edition 9ISBN: 9781118934753 Exercise 1
Edward Jenner, in eighteenth-century England, first inject ed a child with a totally untested smallpox vaccine and then, after a time, injected that child with living smallpox virus. What would be the likely reaction to someone performing a similar experiment today? How do you think a scientist of today would test a potential new vaccine?
Explanation
Verified
Verified
Edward Jenner's Experiment:
• Jenner had observed that a milkman who had suffered from cow pox did not suffer from small pox.
• On the basis of this, he inoculated a young boy, eight-years-old, with fluid from a cow pox blister.
• After a few days, he inoculated the boy with fluid from a small pox blister.
• He expected the boy to remain safe, as he believed that cow pox had made the boy immune to small pox.
In today's world, when medical science is highly advanced, such an experiment would have never been accepted, and would have faced strong legal implications. It would be considered completely unethical to do such a dangerous experiment.
Today, a potential vaccine has to undergo the following stages before it can be used:
1. Pre clinical trials : this includes studies to evaluate the safety, immunogenicity, and protection offered by the candidate vaccine in different animal models like mice, rabbits, or monkeys.
2. Clinical trials : These tests are conducted in humans. The clinical trial of a vaccine is a three-phase process:
Phase-I: A small group of individuals receive the vaccine and its effects are studied.
Phase-II: More individuals are included, for example individuals who have characteristics (age, physical health, etc.) similar to those people for whom the vaccine is being developed.
Phase-III: Thousands of people are vaccinated, and the safety and efficacy is tested and validated.
3. Regulatory review and approval : The sponsor of a new vaccine has to follow an approval process, which includes:
1. An investigational new drug application
2. A pre licensure clinical trial
3. A biologics license application
4. The inspection of the manufacturing facility
5. The presentation of the findings to the FDA's Vaccines and Related Biological Products Advisory committee
• Jenner had observed that a milkman who had suffered from cow pox did not suffer from small pox.
• On the basis of this, he inoculated a young boy, eight-years-old, with fluid from a cow pox blister.
• After a few days, he inoculated the boy with fluid from a small pox blister.
• He expected the boy to remain safe, as he believed that cow pox had made the boy immune to small pox.
In today's world, when medical science is highly advanced, such an experiment would have never been accepted, and would have faced strong legal implications. It would be considered completely unethical to do such a dangerous experiment.
Today, a potential vaccine has to undergo the following stages before it can be used:
1. Pre clinical trials : this includes studies to evaluate the safety, immunogenicity, and protection offered by the candidate vaccine in different animal models like mice, rabbits, or monkeys.
2. Clinical trials : These tests are conducted in humans. The clinical trial of a vaccine is a three-phase process:
Phase-I: A small group of individuals receive the vaccine and its effects are studied.
Phase-II: More individuals are included, for example individuals who have characteristics (age, physical health, etc.) similar to those people for whom the vaccine is being developed.
Phase-III: Thousands of people are vaccinated, and the safety and efficacy is tested and validated.
3. Regulatory review and approval : The sponsor of a new vaccine has to follow an approval process, which includes:
1. An investigational new drug application
2. A pre licensure clinical trial
3. A biologics license application
4. The inspection of the manufacturing facility
5. The presentation of the findings to the FDA's Vaccines and Related Biological Products Advisory committee
Microbiology 9th Edition by Laura Black, Jacquelyn Black
Why don’t you like this exercise?
Other Minimum 8 character and maximum 255 character
Character 255
