Method of preparation of

Viral vaccine

Submitted to Submitted by

Dr. Maryam Sarwat Prasoon Kashyap

B.Pharm (6th Sem, B1)
 VACCINE

• It is the Suspension of attenuated or killed viruses used for prevention or treatment of infectious viral diseases.

• Vaccines interact with the immune system and often produce an immune response similar to that produced by the
natural infection, but they do not subject the recipient to the disease and its potential complications. Many vaccines
also produce immunologic memory similar to that acquired by having the natural disease.
• The discipline of vaccination was first rooted by Edward Jenner and Louis Pasteur:
- In 1796 Jenner learned of the story behind small pox and by 1796 the vaccine was safely regulated for children and
adults.
- In 1880s, the second generation of vaccines was introduced by louis Pasteur for cholera and anthrax.
TYPES OF VACCINES
- Live, Attenuated vaccines: contains a version of living microbe that is weakened in the lab.
E.g. vaccines against measles, mumps and chicken pox.

- Killed (Inactivated) vaccines: produced by killing the disease causing microbe with chemicals, heat and
radiation.
E.g. influenza, hepatitis A and polio.

- Toxoid vaccines: contains a toxin or a chemical made by the bacteria or virus. They make you immune to the
harmful effects of the infection, instead of to the infection itself.
E.g. Crotalus Atrox toxoid used to vaccinate dogs against rattlesnake bites

- Biosynthetic vaccines: contain manmade substances that are very similar to pieces of the virus or bacteria.
E.g. Hepatits B vaccine.
 HOW DO VACCINES WORK

Each pathogen is made up of several subparts,

usually unique to that specific pathogen and the
disease it causes.

The subpart of a pathogen that causes the formation

of antibodies is called an antigen.
Vaccine is made up of the antigen itself or the blueprint so that the
body will produce the antigen, this weakened version will not cause
the disease in the person receiving the vaccine, but it will prompt their
immune system to respond much as it would have on its first reaction
to the actual pathogen.
 VIRAL VACCINE

• Viral vaccines are designed to help target viruses They can make a virus infection less severe, although many of them
have to be given in a specific time frame after contracting the virus in order to be effective.

• The common factor among our most effective antiviral vaccines is that they were developed to mimic our natural
immune response to the pathogen.

• The eradication of smallpox and the significant progress made toward polio eradication are clear examples of the great
impact of Viral vaccines. Most of the viral vaccines introduced over the past century were empirically developed E.g.
Poliomyelitis, measles, mumps, and rubella.
 Types of Viral vaccines
1. Live viral vaccines
Live virus vaccines are prepared from viral strains that have been attenuated, but retain their ability to replicate in the human host and thus
their ability to induce protective immune responses. immunological advantages for utilizing this vaccine are:
e.g. the yellow fever vaccine strain and polioviruses

2. Inactivated viral vaccines

Whole inactivated virus preparations are prepared by simply inactivating viral particles by heat, UV irradiation or by special chemical
treatments. Formalin and beta-propiolactone are the most commonly used chemicals for this purpose.
e.g. Vaccines against polioviruses and influenza

3. Recombinant viral proteins

The advance in methods of protein manufacturing made it possible to express desired viral proteins on a large scale to be used as vaccine
antigens. Bacterial, yeast, insect, and mammalian cell lines have been used for this purpose.
e.g. hepatitis B

4. Virus-like particles (VLPs)

VLPs are multimeric structures assembled from viral structural proteins. They often display viral surface proteins in a high-density repetitive
manner on their surface, which may play a role in the enhanced immunogenicity.
e.g. human papillomavirus
 Vaccine type Diseases
Measles, mumps, rubella (MMR combined vaccine)
Varicella (chickenpox)
Live, attenuated
Influenza (nasal spray)
Rotavirus
Polio (IPV)
Inactivated/Killed
Hepatitis A
Diphtheria, tetanus (part of DPT combined
Toxoid (inactivated toxin)
immunization)

Hepatitis B
Influenza (injection)
Subunit/conjugate
Pertussis (part of DPT combined immunization)
Pneumococcal
HOW ARE VACCINES MADE?
 COMPONENTS OF A VACCINE
Vaccines contain tiny fragments of the disease-causing organism along with other ingredients to keep the vaccine safe
and effective.

ANTIGEN: All vaccines contain an active component (the antigen) which generates an immune response, or the
blueprint for making the active component. 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.

PRESERVATIVES: It prevents the vaccine from becoming contaminated once the vial has been opened, if it will be
used for vaccinating more than one person. The most commonly used preservative is 2-phenoxyethanol.

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).
SURFACTANTS: It keeps all the ingredients in the vaccine blended together. They prevent settling and clumping of
elements that are in the liquid form of the vaccine.

RESIDUALS: These are tiny amounts of various substances used during manufacturing or production of vaccines that
are not active ingredients in the completed vaccine.

DILUENT: 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.

ADJUVENT: 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. The adjuvant may be a tiny amount of aluminium
salts (aluminium phosphate, aluminium hydroxide or potassium aluminium sulphate).
• Vaccine development focuses on vaccine discovery, formulation, and delivery devices enabled by alternative
administration approaches
• Its strategies mainly concentrate on the use of biomaterials, biomolecular engineering, nanotechnology, and
microfabrication techniques.

Factors to in consideration for the development of vaccine:

i. Vaccine manufacturer
ii. Age - child vs adults
iii. Vaccine dosage - primary or booster
iv. Case definition- standard
v. Method of surveillance
vi. Background condition
 Paradigm of vaccine development in a traditional condition

CLINICAL TRIAL PHASE I

Safety and
immunogenicity of a CLINICAL TRIAL PHASE II
vaccine is tested in a few Monitor safety, potential side
low-risk individuals effects, immune response and
determine optimum dosage
and schedule
CLINICAL TRIAL PHASE III
Address clinical efficacy in
disease prevention and provide
safety information.
Submission
The vaccine application is
submitted to regulatory
authorities for approval to
market
 REFERENCES

• https://www.who.int/news-room/feature-stories/detail/how-are-vaccines-developed
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7534801/
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150210/
• https://en.wikipedia.org/wiki/Vaccine#Production
• https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2013000200103
Thank you