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Biologics
Biologics
Biologics – also known as “biologicals”
Wide range of medicinal products
produced by biological processes .
Composed of sugars, proteins, or
nucleic acids or complex combinations
of these substances, or may be living
entities such as cells and tissues.
Isolated from a variety of natural sources
and may be produced by biotechnology
methods and other technologies
They include:
vaccines
blood and blood derivatives
allergenic patch tests and extracts
tests to detect HIV and hepatitis
gene therapy products
cells and tissues for transplantation,
new treatments for cancers, arthritis,
and other serious diseases.
Vaccine
Active immunization because the
immune system is stimulated to
develop its own immunity against
the pathogen.
Passive immunity from the injection
of antibodies formed by another
animal (e.g., horse, human) which
provide immediate protection for the
recipient.
Antibody (IgG, IgM) concentration (titer)
The characteristics of immunity produced by active immunization and passive immunotherapy
Passive
immunotherapy
Injection
Boosters
Initial
inoculation
Time
Active
immunization
Principles of Vaccination
Antigen
A live or inactivated substance
(e.g., protein, polysaccharide)
capable of producing an immune
response
Antibody
Protein molecules (immunoglobulin) produced by B
lymphocytes to help eliminate an
antigen
A vaccine :
is a biological preparation that improves
immunity to a particular disease.
typically contains an agent that
resembles a disease-causing
microorganism.
The agent stimulates the body's immune
system to recognize the agent as
foreign, destroy it, and "remember" it, so
that the immune system can more easily
recognize and destroy any of these
microorganisms that it later encounters.
Classification of Vaccines
Inactivated (killed)
Live attenuated
viral
bacterial
Killed
Vaccines containing killed microorganisms – these are
previously virulent micro-organisms which have been killed
with chemicals or heat. Examples are vaccines against flu,
cholera, bubonic plague, polio and hepatitis A.
Attenuated
Some vaccines contain live, attenuated microorganisms.
The organism has been cultured so as to reduce its
pathogenicity, but still retain some of the antigens of the
virulent form.
They typically provoke more durable immunological
responses and are the preferred type for healthy adults.
Examples include the viral diseases yellow fever, measles,
rubella, and mumps and the bacterial disease typhoid. The
live Mycobacterium tuberculosis vaccine developed by
Calmette and Guérin is not made of a contagious strain, but
contains a virulently modified strain called "BCG" used to
elicit immunogenicity to the vaccine.
Live Attenuated Vaccines
Attenuated form of the "wild" virus
or bacterium
Must replicate to be effective
Immune response similar to natural
infection
Usually effective with one dose
Live Attenuated Vaccines
Severe reactions possible
Interference from circulating
antibody
Fragile – must be stored and
handled carefully
Inactivated Vaccines
Cannot replicate
Generally not as effective as live
vaccines
Less interference from circulating
antibody than live vaccines
Generally require 3-5 doses
Antibody titer may diminish with time
Inactivated Vaccines
Whole
viruses
bacteria
Fractional
protein-based
toxoid
subunit
polysaccharide-based
pure
conjugate
Toxoid
In some diseases, diphtheria and tetanus are
notorious examples, it is not the growth of the
bacterium that is dangerous, but the protein toxin
that is liberated by it.
Treating the toxin with, for example,
formaldehyde, denatures the protein so that it is
no longer dangerous, but retains some epitopes
on the molecule that will elicit protective
antibodies.
Subunit
Protein subunit – rather than introducing an inactivated or
attenuated micro-organism to an immune system (which
would constitute a "whole-agent" vaccine)
A fragment of it can create an immune response.
Examples include
-
Subunit vaccine against Hepatitis B virus composed of
only surface proteins of the virus (previously extracted
from the blood serum of chronically infected patients, but
now produced by recombination of viral genes into yeast).
-
Virus-like particle (VLP) vaccine against human
papillomavirus (HPV) that is composed of the viral major
capsid protein.
-
Hemagglutinin and neuraminidase subunits of the
influenza virus.
Conjugate
certain bacteria have polysaccharide outer
coats that are poorly immunogenic. By
linking these outer coats to proteins (e.g.
toxins), the immune system can be led to
recognize the polysaccharide as if it were a
protein antigen. This approach is used in
the Haemophilus influenzae type B vaccine.
Conjugation
Conjugate vaccine
Bacteria
Carrier
protein
Polysaccharide linked to
carrier protein
Polysaccharide
(sugar) coating
Conjugation is the process of attaching (linking) the
polysaccharide antigen to a protein carrier (e.g. diphtheria or
tetanus) that the infant’s immune system already recognises in
order to provoke an immune response
Immunisation Department, Centre for Infections
Valence: vaccines may be :
- Monovalent (univalent) which designed to
immunize against a single antigen or single
microorganism
- Multivalent (polyvalent) which designed to
immunize against two or more strains of the
same microorganism, or against two or more
microorganisms.
In certain cases a monovalent vaccine may
be preferable for rapidly developing a strong
immune response.
Vaccine composition
In addition to the antigen, vaccines may contain some or all of
the following components:
Component
Purpose
Example
Adjuvants
enhance the immune response to a
vaccine
aluminium salts
Preservatives
prevent bacterial or fungal contamination
of vaccine
thiomersal
Additives
stabilise vaccines from adverse
conditions such as freeze-drying or heat,
thereby maintaining a vaccine’s potency
gelatine
Residuals from
manufacturing
process
Inactivating agents
formaldehyde
Antibiotics - prevent bacterial
contamination during manufacturing
process
neomycin, streptomycin,
polymyxin B
Egg proteins- some vaccine viruses are
grown in chick embryo cells
Yeast proteins
Immunisation Department, Centre for Infections
influenza, yellow fever
HepB vaccine
Developing immunity
The immune system recognizes vaccine
agents as foreign, destroys them, and
'remembers' them.
When the virulent version of an agent
comes along the body recognizes the
protein coat on the virus, and thus is
prepared to respond, by
(1) neutralizing the target agent before it can
enter cells, and
(2) by recognizing and destroying infected
cells before that agent can multiply to vast
numbers.
When two or more vaccines are mixed together in
the same formulation, the two vaccines can
interfere.
This most frequently occurs with live attenuated
vaccines, where one of the vaccine components is
more robust than the others and suppresses the
growth and immune response to the other
components.
Effectiveness
Vaccines do not guarantee complete protection from
a disease.
Sometimes this is because the host's immune
system simply doesn't respond adequately or at all.
This may be due to a lowered immunity in general
(diabetes, steroid use, HIV infection) or because the
host's immune system does not have a B cell
capable of generating antibodies to that antigen.
Even if the host develops antibodies, the human
immune system is not perfect and in any case the
immune system might still not be able to defeat the
infection.
Adjuvants are typically used to boost immune
response.
Most often aluminium adjuvants are used
Squalene are also used in some vaccines .
The efficacy or performance of the
vaccine is dependent on a number of
factors:
the disease itself (for some diseases vaccination
performs better than for other diseases) .
the strain of vaccine (some vaccinations are for
different strains of the disease) .
whether one kept to the timetable for the
vaccinations .
some individuals are 'non-responders' to certain
vaccines, meaning that they do not generate
antibodies even after being vaccinated correctly.
other factors such as ethnicity or genetic
predisposition .
Compulsory Vaccines
Bacillus Calmette-Guerin Vaccine
(BCG)

INDICATIONS
 All newborns
 All tuberculin negative infants

PRECAUTIONS & CONTRAINDICATIONS(CI):
 Give only to PPD negative children
 CI in persons with immunodeficiencies
 CI during pregnancy
Bacillus Calmette-Guerin Vaccine
(BCG)
SIDE EFFECTS
 Local



Skin ulceration, regional lymphadenitis
Subcutaneous abscess
Generalized


Anaphylaxis, generalized BCG infection
(rare): osteitis
Hepatitis B

PREPARATIONS
 ENGERIX-B
 RECOMBIVAX HB
Hepatitis B


ADMINISTRATION:
 0.5 -1 ML, anterolateral thigh or deltoid
 IM injection
 at 0,1 and 6 months
SIDE EFFECTS:
 Pain
 Arthralgia
Poliomyelitis Prophylaxis

PREPARATIONS




OPV
eIPV
2 drops orally
SC injection
PRECAUTIONS & CONTRAINDICATIONS(CI)



SABIN (Live attenuated)
SALK (killed)
ADMINISTRATION


(A) Oral (OPV)
(B) Inactivated (eIPV)
(a) OPV
(b) IPV
pregnancy, immunodeficiency
neomycin hypersensitivity
ADVERSE REACTIONS

OPV
paralytic disease (rare)
Diphtheria, Tetanus & Pertussis (DTP)

PREPARATIONS



< 7 years : DTP, DT, DTaP (acellular
pertussis vaccine)
> 7 years : Td, TdaP
ADMINISTRATION

IM
Diphtheria, Tetanus & Pertussis (DTP)

CONTRAINDICATIONS (CI)




Encephalopathy within 7 days
Progressive or unstable neurological disorders
Anaphylactic reaction to a previous dose
PRECAUTIONS

severe systemic reactions such as
 Temp > 40.50C
 persistent inconsolable crying > 3 hours
 Collapse episodes
 Convulsions
Measles, Mumps & Rubella (MMR)

PREPARATIONS:



ADMINISTRATION:


MEASLES.
MMR.
SC.
INDICATIONS:

Primary immunization at 1 & 6 years.
Measles, Mumps & Rubella (MMR)
PRECAUTIONS & CONTRAINDICATIONS
 Pregnancy
 Anaphylaxis to eggs
 Immunodeficiency and
immunosuppression
 Immunoglobulins within 3-11 months
Measles, Mumps & Rubella (MMR)

ADVERSE REACTIONS






Fever ,rash (7 days post vaccination)
Arthralgia , arthritis (rubella)
Encephalitis [rare] (measles, mumps)
Suppression of PPD skin test (measles)
Convulsions in prone children(measles)
Thrombocytopenia
Haemophilus Influenzae Type B

ADMINISTRATION



INDICATIONS



IM
2,4,6 months, booster at 15 months
Children under 5 years of age
High risk children
SIDE EFFECTS:


Local pain and erythema
Mild fever
Varicella Prophylaxis

PREPARATIONS:


Varivax vaccine (MSD)
ADMINISTRATION:
0.5 ml IM
 12 months and above……..2 doses

Varicella Prophylaxis


INDICATIONS:
 All children 12 months-18 years: (if no
history of varicella)
EFFICACY:

70-90%
Varicella Prophylaxis

PRECAUTIONS & CONTRAITNDICATIONS:




Immunocompromised patients
Within 5 months of IG
Children on long term salicylates
SIDE EFFECTS:


Fever , rash
Zoster
Hepatitis A


NATURE OF VACCINE:
 Killed formalin inactivated vaccine.
PREPARATIONS:
 Various preparations available
e.g. Havrix 720 Junior, Havrix 1440 etc.
Hepatitis A

INDICATIONS:
 children 1 year and above
 Susceptible children in endemic areas
 Chronic liver disease
 Hemophilia
Hepatitis A


ADMINISTRATION:
 IM injection
 2 doses, at least 6 months apart
ADVERSE REACTIONS:
 Local reactions, fever
 Rare: anaphylaxis
Additional Vaccines
Pneumococcal Prophylaxis

PREPARATIONS:



Purified capsular polysaccharide of 23
serotypes of Streptococcus pneumoniae
7 valent conjugated vaccine
ADMINISTRATION:


IM / SC
1 dose/booster 5 years
Pneumococcal Prophylaxis

INDICATIONS:
 Primary vaccination (conjugate vaccine)
 children 2 yr. or older with
 Anatomical or functional asplenia
 Sickle cell disease
 Nephrotic syndrome
 Immunosuppression
Pneumococcal Prophylaxis

SIDE EFFECTS:
 Soreness , erythema, fever, myalgia
 Anaphylactic reactions (rare)
Meningococcal Prophylaxis


PREPARATIONS:
 monovalent (A or C)
 bivalent (A & C)
 quadrivalent (A,C,Y & W-135)
 quadrivalent conjugate quadrivalent
ADMINISTRATION:

SC
Meningococcal Prophylaxis


INDICATIONS:
 Control of outbreaks
 Children with complement deficiencies
or asplenia
SIDE EFFECTS:
 local erythema and discomfort
 transient fever
Influenza Virus

Nature of vaccine:



Killed vaccine.
Live attenuated
Preparations:



whole and “split virus” vaccines.
“split virus” vaccines are recommended for
children 6 months and older.
composition of the vaccine is changed
annually.
Influenza Virus

ADMINISTRATION:




IM (killed).
Live attenuated (intranasal).
1 dose during influenzae season.
Children 6months-9 years should receive an
additional dose, 4 weeks after the 1st dose, if
not previously immunized.
Influenza Virus

Indications:

chronic cardio-respiratory disease
 asthma
 cystic fibrosis
 bronchopulmonary dysplasia
Influenza Virus

Indications:







Sickle cell anemia.
Chronic salicylate therapy.
Diabetes mellitus.
Chronic renal disease.
Chronic metabolic disease.
immunosuppressive conditions: cancer, HIV etc.
Hospital personnel with significant patient
contact.
Influenza Virus

Contraindication:
Anaphylaxis to previous dose.
 Hypersensitivity to eggs.


Adverse Reaction:
Soreness at injection site.
 Allergic response.
 Guillain-Barré Syndrome.

New Vaccines


Rota virus vaccines
Human papilloma virus vaccine