Vaccines are tiny fragments of the disease-causing organism or the blueprints for making the tiny fragments. They contain other ingredients to keep the vaccine safe and effective.

1. DR RUTH AFUNWA
BTG 708
VACCINE PRODUCTION

2. WHAT IS A VACCINE?
• Vaccines are tiny fragments of the disease-
causing organism or the blueprints for making
the tiny fragments. They contain other
ingredients to keep the vaccine safe and
effective.
• Each vaccine component serves a specific
purpose

3. ANTIGEN
• All vaccines contain an active component (the
antigen) which generates an immune
response.
• The antigen may be a small part of the
disease-causing organism, like a protein or
sugar, or it may be the whole organism in a
weakened or inactive form.

5. PRESERVATIVES
• Preservatives are substances added to
pharmacutical preparations to prevent
contamination.
• It prevents the vaccine from becoming
contaminated once the vial has been opened,
(multiple use).
• one-dose vials do not contain preservatives; are
discarded after the single dose is administered.
• The most commonly used preservative is 2-
phenoxyethanol. It has been used for many years
in a number of vaccines, safe and low toxicity in
humans.

6. STABILIZERS
• Stabilizers prevent chemical reactions from
occurring within the vaccine and keep the
vaccine components from sticking to the
vaccine vial.
• Stabilizers can be sugars (lactose, sucrose),
amino acids (glycine), gelatin, and proteins
(recombinant human albumin, derived from
yeast).

8. SURFACTANTS
• Surfactants keep all the ingredients
in the vaccine blended together.
They prevent settling and clumping
of elements that are in the liquid
form of the vaccine.

9. RESIDUALS AND DILUENT
• Residuals are tiny amounts of various substances
used during manufacturing or production of
vaccines that are not active ingredients in the
completed vaccine.
• Examples: egg proteins, yeast or antibiotics.
• Residual traces of these substances are added in
small quantities measured as parts per million or
parts per billion.
• A diluent is a liquid used to dilute a vaccine to the
correct concentration immediately prior to use.
The most commonly used diluent is sterile water.

10. ADJUVANT
• . An adjuvant improves the immune response
to the vaccine, sometimes by keeping the
vaccine at the injection site for a little longer
or by stimulating local immune cells.
• Examples: a tiny amount of aluminium salts
• (like aluminium phosphate, aluminium
hydroxide or potassium aluminium sulphate).
• Aluminium has no long-term health problems,
and easy to digest

11. VACCINE DEVELOPMENT
• A new vaccine must undergo screenings and
evaluations to determine which antigen
should be used to invoke an immune
response.
• This preclinical phase is done without testing
on humans.
• An experimental vaccine is first tested in
animals to evaluate its safety and potential to
prevent disease.

12. CLINICAL TRIALS
Phase 1
• The vaccine is given to a small number of volunteers
• CHECK safety, immune response, right dosage.
• Generally in this phase vaccines are tested in young, healthy adult volunteers.
Phase 2
• The vaccine is then given to several hundred volunteers
• CHECK further safety , immune response.
• Participants in this phase have the same characteristics (such as age, sex)
• Multiple trials in this phase to evaluate various age groups and different formulations of
the vaccine.
• CONTROL GROUP: no vaccine is administered to determine whether the changes in the
vaccinated group are attributed to the vaccine, or have happened by chance.
Phase 3
• The vaccine is next given to thousands of volunteers –
• Compared to a similar group of people who didn’t get the vaccine, but received a
comparator product –
• CHECK: to determine if the vaccine is effective against the disease
• Safety
• Conducted across multiple countries and multiple sites within a country to assure the
findings of the vaccine performance apply to many different populations.

13. STAGES OF VACCINE PRODUCTION
• Vaccine production has several stages. Process of
vaccine manufacture has the following steps:
• Inactivation – This involves making of the antigen
preparation
• Purification – The isolated antigen is purified
• Formulation – The purified antigen is combined
with adjuvants, stabilizers and preservatives to
form the final vaccine preparation.

14. GENERATING THE ANTIGEN FROM THE
MICROBE
• The antigen is generated from the microbe.
• Organism is grown either on primary cells such as
chicken eggs (e.g. in influenza) or on cell lines or
cultured human cells (e.g. Hepatitis A).
• Bacteria against which the vaccines are developed may
be grown in bioreactors (e.g. Haemophilus influenzae
type b).
• The antigen may also be a toxin or toxoid from the
organism (e.g. Diphtheria or tetanus
• Proteins or parts from the organism can be generated
in yeast, bacteria, or cell cultures. Bacteria or viruses
may be weakened using chemicals or heat to make the
vaccine (e.g. polio vaccine).

15. • Vaccines are produced in large
• Administered to large
populations of children and
adults
• Used as prophylaxis

16. TYPES OF VACCINES

17. TYPES OF VACCINES
• The main types of vaccines that act in different
ways are:
• Live attenuated vaccines
• Inactivated vaccines
• subunit, recombinant, conjugate, and
polysaccharide vaccines
• Toxoid vaccines
• mRNA vaccines
• Viral vector vaccines

18. Live attenuated vaccines
• A live version of the germ or virus
that causes a disease is injected into
the body. Although the germ is a live
specimen, it is a weakened version
that does not cause any symptoms of
infection as it is unable to reproduce
once it is in the body.

19. • More commonly used for viruses.
• The vaccine works by allowing a virus to
reproduce enough for the body to make memory
B-cells
• B cells can recognize and remember a virus and
generate an immune response against it for
many years after their initial response.
• Live-attenuated vaccines trigger an immune
response that is similar to what would occur
during a natural infection
• The vaccinated person cannot pass on the virus
to other people and will not become ill with the
disease caused by the virus

20. • Lifelong immunity from disease through live-
attenuated vaccines is achieved with only one
or two doses.
• Live-attenuated vaccines are used for
Measles, mumps, and rubella (MMR combined
vaccine)
Rotavirus
Smallpox
Chickenpox
Yellow fever

21. Inactivated vaccines
• An inactivated vaccine uses a strain of a bacteria
or virus that has been killed with heat or
chemicals.
• This dead version of the virus or bacteria is then
injected into the body.
• They do not trigger an immune response that is
as strong as that triggered by live-attenuated
vaccines.
• Inactivated vaccines do not offer lifelong
immunity
• Need for boaster doses

22. • They may cause fewer side effects than
live-attenuated vaccines.
• The types of diseases that inactivated
vaccines are used for include:
• Hepatitis A
• Flu
• Polio
• Rabies

23. Subunit, recombinant, conjugate, and
polysaccharide vaccines
• These vaccines use particular parts of the germ or
virus.
• They can trigger very strong immune responses in
the body because they use a specific part of the
germ.
• The immune responses are strong but require
boaster doses
• They are suitable for people with weakened
immune systems and long-term health
conditions.

24. • These types of vaccines are used to create
immunity against the following diseases:
• Hib (Hemophilus influenza type b)
• Hepatitis B
• Human papillomavirus (HPV)
• Whooping cough
• Pneumococcal disease
• Meningococcal disease
• Shingles

25. Subunit vaccines
• Subunit vaccines isolate specific antigens from a
germ or virus for use in the vaccine.
• Antigens from the surface of the germ or virus
are responsible for triggering an immune
response in the body.
• The antigens are specifically chosen according to
the strength of the immune response they
generate.
• Subunit vaccines do not cause many side effects
because they are so specifically targeted.

26. Recombinant vaccines
• Recombinant vaccines are made through
genetic engineering.
• The gene that creates the protein (disease
causing) for a bacteria or virus is isolated and
placed inside an individual (host) cell’s genes.
• When individual (host) cell reproduces, it
produces vaccine proteins (antibodies) that
will recognize the protein from the
microorganism and protect the body against
it.
• Thus the body is protected

27. Conjugate vaccines
• Conjugate vaccines use two different components
namely;
• parts from the outer antigen coat of the bacteria
or virus, usually weak and cannot cause illness or
generate an immune response in the body.
• carrier protein using chemicals; stronger and are
linked the weak antigen coat
• This combination of the weak antigen coat and
stronger carrier proteins triggers the immune
system to act more aggressively against the weak
antigen.

28. Polysaccharide vaccines
Toxoid vaccines
• Polysaccharide vaccines use sugar molecules (known as
polysaccharides) from the outer layer of a bacteria or
virus.
• These sugar molecules are chemically linked to carrier
proteins and work similarly to conjugate vaccines.
• Toxoid vaccines
• Use toxins created by the bacteria or virus to create
immunity to the specific parts of the bacteria or virus
that cause disease, and not the entire bacteria or virus.
• The immune response is focused on this specific toxin.
• Not lifelong immunity and requires boaster doses
• Creates immunity against diphtheria and tetanus.

29. mRNA vaccines
• This technology has been in development for
decades.
• They have benefits namely:
• short manufacturing times
• Low manufacturing costs.
• Must be kept at low temperatures due to the
fragility of the mRNA.

30. Viral vector vaccines
• Viral vector vaccines modify another
virus and use it as a vector to deliver
protection from the intended virus.
• Some of the viruses used as vectors
include adenovirus, influenza,
measles virus and …….

31. DNA vaccines
• The specific DNA that creates specific antigens from
a germ is injected into the body, it is reproduced by
the body and is recognized by the immune system.
• The immune response will then protect the body
against further infection and will continue to protect
in future.
• The antigen introduced into the body can sometimes
be degraded or consumed by the body before the
immune system can generate a full attack against the
antigen.

32. Recombinant vector vaccines
• Works as a natural infection and are good at
training the immune system to recognize and
attack germs.
• They work by reproducing a live virus that has
been engineered to carry extra genes from the
germ infecting the body.
• The extra number of genes produce the
proteins that the immune system needs to
recognize and protect against.

33. • Some vaccines may cause more side effects
than others e. g. live-attenuated vaccine
• Not suitable for people living with long-term
health conditions or people with a weakened
immune system.
• Some vaccines use live versions of the
organism, other vaccines can use only a part
of the organism to trigger an immune
response
• May produce stronger immune action against
the germ because of its specificity.

34. THE END