Vaccines work by exposing the immune system to antigens from viruses or bacteria. This triggers an immune response that produces antibodies to fight future infections from these pathogens. Vaccines contain weakened or killed forms of viruses or bacteria, along with preservatives and adjuvants. When administered, they mimic natural infections and induce immunity. Traditional vaccines include live-attenuated, inactivated, toxoid and subunit vaccines. Innovative vaccines include conjugate vaccines, which link weak antigens to strong carriers, and recombinant vector vaccines. Quality control ensures vaccines are safe, potent and effective through in-process and final product testing.

1. st
VACCINATION AND IT’S DELIVERY SYSTEM
Presenting By :- sneha pk
M-pharm-1 yr
[pharmaceutics]

2. VACCINATION

6. INTRODUCTION
The word “vaccine” originates from the Latin
Variolae vaccinea (cowpox), which Edward Jenner
demonstrated in 1798 could prevent smallpox in
humans. Today the term ‘vaccine’ applies to all
biological preparations, produced from living
organisms, that enhance immunity against disease
and either prevent (prophylactic vaccines) or, in some
cases, treat disease (therapeutic vaccines). Vaccines
are administered in liquid form, either by injection, by
oral, or by intranasal routes.
 Ex. Polio , Hepatitis –A……etc.

8. LYMPHOCYTES
 Small white blood cells which are responsible for much of
the work of the immune system.
 Lymphocytes can be divided in to 3 classes
1.B cells
2.T cells
3.Natural killer cells

9. B & T CELLS
• T cells play a central role in cell- mediated immunity
while, B cells are lymphocytes that play a large role in
humoral immune response.
• B cell is an essential component of the adaptive immune
system
• B cells spend their entire life in the bone marrow while
the T-cells leave the bone marrow at an early age and
travel to the thymus, where they mature.
• The principal function of B cells is to make antibodies
against antigens, perform the role of antigen presenting
cells (APC) and eventually develop in to memory B cells
after activation by antigen interaction.

10. • On the other hand, T-cells constitute 60 - 75% of blood
lymphocytes.
• They can be distinguished from other lymphocytes by the
presence of a T cell receptor (TCR) on the cell surface.
• Another key feature of B cells and T cells, includes the
receptors it has in its surface.
• T cells recognize a linear sequence of amino acids where
as, B cells the spatial arrangement of proteins, nucleic
acids, polysaccharides or lipids.

11.  HELPER T CELLS; They assist other white blood
cells in immunologic processes, including maturation
of B cells in to plasma cells and memory B cells, and
activation of cytotoxic T cells and macrophages.
 CYTOTOXIC T CELLS; They destroy virally infected
cells and tumor cells and are also implicated in
transplant rejection.
 REGULATORY T CELLS; They are formally known
as suppressor T cell and are crucial for the
maintenance of immunological tolerance.
 MEMORY T CELLS; These are a subset of antigen
specific T cells that resist long term after an infection
has resolved.

12.  NATURAL KILLER CELLS
• They comprise about 10-50% of the lymphocytes of
circulating blood.
• The role of NK cells is analogous to that of cytotoxic T
cells in the vertebrate adaptive immune system.
 ANTIGEN PRESENTING CELL
• Cells which do not have antigen specific receptors.
Instead they capture and progress antigens, present
them to T-cell receptors.
• These cells include Macrophages, B-cells and Dendritic
cells.

14. IMMUNIZATION
 It is the process by which an individual's immune system
becomes fortified against an agent (known as the
immunogen)
 Immunization is the process whereby a person is made
immune or resistant to an infectious disease, typically by
the administration of a vaccine.
 There are 2 types of immunizations;
 Active immunization
 Passive immunization.

15.  ACTIVE IMMUNIZATION
 Active immunization can occur naturally when a person
comes in contact with, for example, a microbe.
 The immune system will eventually create antibodies and
other defenses against the microbe.
 Active immunization is process of increasing resistance to
infection where by microorganism or product of their
activity act as a antigens and stimulate certain body cell
produce a antibodies with specific protective capacity
 PASSIVE IMMUNIZATION
 Passive immunization is where pre-synthesized elements
of the immune system are transferred to a person so that
the body does not need to produce these elements itself.

16.  Immunization is done through various techniques, most
commonly vaccination.
 • Vaccines against microorganisms that cause diseases can
prepare the body's immune system, thus helping to fight or
prevent an infection.
 Before the introduction of vaccines, the only way people
became immune to an infectious disease was by actually
getting the disease and surviving it.
 Smallpox (variola) was prevented in this way by
inoculation, which produced a milder effect than the
natural disease.

17. VACCINATION
 Vaccination is administration of antigenic material to
stimulate an individual’s Immune System to develop
adaptive immunity to a pathogen.
 Vaccination is most effective method of preventing
infectious diseases.
 Widespread immunity due to vaccination which is
largely responsible for the worldwide eradication of
small pox and the elimination of diseases such as
Polio, Measles and tetanus from much of the world.

18. Ideal characters of vaccine
 should be 100% efficient in all individuals of any age
 should provide lifelong protection after single
administration .
 Does not evoke any adverse reaction
 should stable under various conditions(temperature, light,
transportation)
 Should be available in unlimited quantities

19. Properties of an ideal vaccine
Give life long immunity
Broadly protective against all variants of organism
Prevent disease transmission
Rapidly induce immunity
Effective in all subjects (the old & very young)
Transmit maternal protection to the foetus
Require few immunisations to induce protection
Not need to be administered by injection (oral, intranasal,
transcutaneous)
Stable, cheap & safe

20.  Vaccines are dead or inactivated organisms or purified
product derived from them.
 There are many types of vaccines, categorized by the
antigen used in their preparation
a) Traditional vaccines
b) Innovative vaccines
TYPE OF VACCINES

21. 1.Traditional Vaccines
 Live-attenuated vaccines
 Inactivated vaccines
 Subunit,recombinant,polysaccharide,and conjugate
vaccines
 Toxoid vaccines
2. Innovative Vaccines
 Conjugate Vaccines
 Recombinant Vector vaccines

22. a) Traditional vaccines
 1. Killed : Some vaccines contain killed, but previously
virulent, microorganism that have been destroyed with
chemicals, heat, radioactivity or antibiotics. Examples are
influenza, cholera, polio, hepatitis A, and rabies.
 2. Live, attenuated – Some vaccines contain live,
attenuated microorganisms. Many of these are active
viruses that have been cultivated under conditions that
disable their virulent properties or that use closely related
but less dangerous organisms to produce a broad immune
response. Example are yellow fever, measles, mumps

23.  3. Toxoid- Toxoid vaccines are made from inactivated
toxic compound that cause illness rather than the
microorganism. Examples are Tetanus and Diphtheria.
 4. Subunit – Protein subunit –Rather than introducing an
inactivated or attenuated microorganism to an immune
system (which would constitute a whole agent vaccine), a
fragment of it can create an immune response.

24. B) Innovative vaccines
 1. Conjugate vaccines- Certain bacteria have
polysaccharide outer coats that are poorly immunogenic.
By linking these outer coats to protein(e.g. toxin), the
immune system can be led to recognize the polysaccharide
as if it were a protein antigen.
 Conjugate vaccines combine a weak antigen with a strong
antigen as a carrier so that the immune system has a
stronger response to the weak antigen
 2. Recombinant vector vaccine- By combining the
physiology of one microorganism and the DNA of the
other, immunity can be created against diseases that have
complex infection process.

25.  3. T-cell receptor peptide vaccine – They show the
modulation of cytokine production and improve cell
mediated immunity and are under development.
 4. Valence –
a) Monovalent- Use to immunize against single antigen.
b) Multivalent- Used to immunize against two or more
microorganism.
 5. Heterotypic – Vaccines that are pathogens of other
animals that either do not cause disease or cause mild
disease in the organism being treated

26. Fig.No:-1

27. 10

28. How do vaccines work?
When inactivated or weakened disease-causing
microorganisms enter the body, they initiate an immune
response. This response mimics the body’s natural
response to infection. But unlike disease- causing
organisms, vaccines are made of components that have
limited ability, or are completely unable, to cause disease.

30. Component of vaccines

31. What does a vaccine contain?
In addition to the bulk antigen that goes into a vaccine,
vaccines are formulated (mixed) with other fluids (such as water
or saline), additives or preservatives, and sometimes adjutants'.
Collectively, these ingredients are known as the excepients.
These ensure the quality and potency of the vaccine over its
shelf-life.
Vaccines are always formulated so as to be both safe and
immunogenic when injected into humans.
Vaccines are usually formulated as liquids, but may be freeze-
dried (lyophilized) for reconstitution immediately prior to the
time of injection.

32. Preservatives
Preservatives Vaccines
Phenol Typhoid , Pneumococcal
Benzethonium chloride Anthrax
2-Phenoxyethanol Inactive Polio
Thimerosal Influenza

33. Adjuvant
ADJUVANT VACCINES
Aluminum salt Hepatitis A& B, Tetanus,
HemopylusInfluanza B
,Pneumococcal, Tetanus,
,diphtheria.
Aluminum saltand mono
phospholipids
Human Papilloma Virus
MF59[oil in wateremulsion] H1N1 influenza

34. General method for preparation of vaccines
The seed lot system
• The starting stage of preparation of all microbial vaccines is the
isolation of suitable microbial strains.
• Microbial strain are mainly isolated from human infections and in
some cases have required elaborate laboratory manipulation and
selection.
• Once a suitable strain is available a sizeable culture is prepared and
distributed in large number of ampoules and then stored at -70
degree or freeze dried. These culture is called ‘ seed lot’.
• The seed is then used to make one or more batches of vaccine
production .
• If it is found satisfactory then it is tested for efficacy and safety in a
clinical trials . Satisfactory result in a clinical trials validate the seed
lot and it is used for production of vaccines.

35. Process of bacterial harvest
 The harvest is a complex mixture of bacterial cell and
metabolic product . The bacterial harvesting depend
on the nature of component that is required and ,may
involved oneor moreof the following procedure:
1.
2.
3.
4.
5.
6.
Killing
Separation
Fractionation
Detoxification
Adsorption
Conjugation

36. Some examples
TAB Vaccine ( Typhoid-ParatyphoidA,B)
It is a sterile suspension of Salmonella typhi and Salmonella paratyphi A and
B.
TAB-C contain Salmonella paratyphi C in addition to TAB.
Preparation
TAB vaccine is a mixed polyvalent vaccine and is prepared by mixing of
simple of vaccines of Salmonella typhi , S . paratyphi A and S. paratyphi B.
These strains are grow in acids digested agar medium and cultivated for 48 hr
at 37 degree .
Harvested with a sterile normal saline solution .
Strain are diluted to form 3000 million organism/ml of Salmonella typhi and
2250 million organism/ml of each S.paratyphi A and B.
Above strain are killed by adding 0.1% formalin or by heat treatment.
Bacterial strain are incubate at 37degree for 4 day for detoxification and then
tested for sterility.

37. bacterial strain are mixed together to contain 1000 million
organism of S. typhi and 750 million organism of each of S.
typhi A and B.
The suspension is transferred to final sterile containers and
freeze dried.
The sterility and abnormal toxicity is evaluate further.
Storage
store in well closed container at temp 2-8 degree.
Dose
Prophylactic 0.5 ml (sc)’ 2-4 injection 2-4 week interval.
Booster dose give every 1-2 yr.
Uses
TAB also mixed with tetanus and cholera vaccine.
Prophylaxis of enteric infection.

38. MMR (measles-mumps-rubella) Vaccine
Measles-Mumps-Rubella vaccines is a mixed preparation containing
suitable live attenuated of measles virus mumps virus and rubella
virus.
Mortality due to measles is still high in countries due to
malnutrition.
It is grown in a chick embryo cells.
Single dose is injected (sc or i. m) in children older than 12
month to protect them from that three diseases.
BCG vaccines
This is a suspension of living cell of strain of Mycobacterium
tuberculosis known as BCG vaccines.
Originally it was given orally but to unreliable absorption from gut
the intracutaneous route is now preferred.
The vaccine is prepared immediately before use by
reconstitution from the dried vaccine with suitable liquid.

39. Quality control of
vaccines
The quality control of vaccine is intended to provide
assurance of safety and efficacy . They are checked in two
ways;
In-process : In this quality control is the control exercised over
starting material and intermediate.
The quality control of diphtheria and tetanus vaccine
required that the product are tested for the presence of free
toxins.
Final product control : Final product control is the quality
control exercised by the monographs of a pharmacopoeia of
over product in their final container .

40. All vaccine are tested for;
1. Identity test
2. Potency test
3. Safety test
4. sterilityassay
5. Free formalin test
6. Abnormal toxicity testing
7. Phenol concentration
8. Presence of aluminum and calcium

41. REFERENCE
Drug And Pharmaceutical Science ; Novel Drug
Delivery System Second Edition By Tie W. Chien
Published By Marcel Dekker New York; Hongkong
1992 Pg No. 197;301.
N.K.Jain , Controlled and Novel Drug Delivery , CBS
Publisher & Distributer , New Delhi , First Edition
1997.Pg.No;-503 507
• K.R Kuchekar , MicrobiologyAnd Immunology, By
Nirali Prakashan New Delhi. Pg No 57-62.
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