This is a practical session during vaccine and serum course. A course for the fourth year undergraduate students (Pharmacology domain) at department of virology, faculty of veterinary medicine, Cairo University.
2. 5 golden rules
• Enjoy learning
• Don’t bother your self by writing everything, just few notes will be
good
• Give your mind a chance to do what it is created for!? …Thinking
• Please, ask, ask and ask again, if you don’t understand, if you doubt, if
you understand, even if you fall asleep during a class the first thing
you should do when you wakeup is to………. ask
• Don’t forget the previously mentioned 4 rules
3.
4.
5. I have a little story, I want to
share it with all of you
6.
7. It is a story of
everlasting game
between the
human and
infectious
diseases
The Miasmatic
theory
9. History of medicine
1. Medicine at 1800 and before
2. The rise of scientific medicine in
the 19th century
3. Medicine in the 20th century and
after
chemotherapy
Nano-medicine
Immunization
19. Exploratory (vaccine design): This research-intensive phase of the
vaccine development process is to identify antigens that might help
prevent or treat a disease.
20. Pre-clinical: researchers use tissue-culture or cell-culture systems and
animal testing to determine whether the vaccine will produce
immunity. Many vaccines don’t move on to the next stage of
development because they fail to produce that immunity or prove
harmful to test subjects.
21. Clinical development: An institution that will host the clinical trial holds a
review board for approval of the application. Once the proposal has been
approved, the vaccine must pass three trial stages of human testing:
Phase I administers the vaccine to a small group (less than 100 people) with
the goal of determining whether the candidate vaccine is safe and to learn
more about the responses it provokes among test subjects.
Phase II includes hundreds of human test subjects, aims to deliver more
information about safety, immunogenicity, immunization schedule and dose
size.
Phase III thousands or tens of thousands of test subjects, continues to
measure the safety (rare side effects sometimes don’t appear in smaller
groups) and effectiveness of the vaccine.
22. Regulatory review and approval: If a vaccine passes through all three
phases of clinical development, the vaccine developer submits a
Biologics License Application (BLA).
23. Manufacturing: Major drug manufacturers provide the infrastructure,
personnel and equipment necessary to create mass quantities of
vaccines.
24.
25.
26. The cold chain
The 'cold chain' is a system of storing and transporting vaccines at
recommended temperatures from the point of manufacture to the
point of use. That is, the role of the cold chain is to maintain the
potency of vaccines. There is also a concept called 'reverse cold chain',
which is a system of storing and transporting samples at recommended
temperatures from the point of collection to the laboratory.