IMMUNIZATION

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 OVERVIEWS

•Basic vaccine immunology

•Vaccination technique
•National immunization program (NIP),
•IAP Schedule
•Individual vaccines

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 ACTIVE IMMUNIZATION

Administration of all or part of microorganism or a

modified product to stimulate immune response

mimicking natural infection without risk to the

recipient

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 TYPES OF VACCINES

• Live attenuated: BCG,OPV, measles, varicella

• Killed / inactivated:
– Whole cell : Hepatitis A, Rabies, whole cell pertussis (wP)
– Subunit : Hepatitis B, acellular pertussis (aP)
– Toxoid : Tetanus, diphtheria
– Protein conjugated : Hib conjugate, pneumococcal conjugate
– Polysaccharide : Typhoid (Vi),Pneumococcal polysaccharide

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 RESPONSE AFTER IMMUNIZATION
PROTEIN VS POLYSACCHARIDE VACCINES

• Protein antigens stimulate T cells in lymph nodes.

– large quantity of high affinity antibodies are formed.
– Memory cells are formed which produces a more rapid
and higher antibody response on re‐exposure

• Polysaccharide antigens are T cell independent;

– limited antibodies of lesser affinity are formed
– No memory cells are produced so no booster effect on
reexposure to same antigen.

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 RESPONSE TO VACCINES

• Live vaccines • Killed vaccines

• Multifocal lymph node • Usually stimulate
activation regional lymph nodes
• Better immunogenecity • Needs repeated doses
• Less number of doses to maintain optimum
• May provide life long antibody level
immunity after single • Adjuvants may be
dose itself added to increase
immunogenicity

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 DETERMINANTS OF IMMUNE RESPONSE
• Type of vaccine: Live Vs inactivated

Protein Vs polysaccharide

• Vaccine schedule: Adequate interval between

priming doses; optimal interval between priming
and boosting doses

• Age: Immunologic immaturity and interference by

maternal antibody in early life.

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 TECHNIQUE OF VACCINE ADMINISTRATION

• Hands to be cleaned

• Separate needle and syringe for each injection

• Discard needle and syringe safely

• Avoid gluteal region for IM injection

• Gentle pressure at vaccination site for a few

seconds after vaccination

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 Wash hands Open plunger side Correct dose

Correct site Safe disposal

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 TECHNIQUE OF VACCINE ADMINISTRATION

Type of Needle size Route Site

Vaccine
Measles, MMR, 23-25 G, 5/8” Subcutaneous Outer triceps
Varicella area ( Posterior
skin fold)

DPT, TT, Td, 22-25 G IM Deltoid, vastus

DTaP, Hep B, 1-2” lateralis ( antero
Hib, PCV, Hep lateral thigh )
A

BCG given intradermally over deltoid region

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 COLD CHAIN

• The cold chain is the system of storing and

transporting vaccines at recommended
temperatures from the point of manufacture to the
point of use.
• Safe zone for short term storage: 2◦C to 8◦C
• Equipment for cold chain maintenance:
‐ ILR/Refrigerator/Vaccine carrier
‐ Temperature monitoring devices

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DOMESTIC REFRIGERATOR AND VACCINE
STORATGE

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 VACCINE VIAL MONITOR (VVM)
• The combined effect of time and temperature
cause the inner square of the VVM to darken
gradually & irreversibly.

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 THERMOSENSITIVITY OF VACCINES

HEAT SENSITIVE Most

• BCG(recon.)
• OPV
• MEASLES
• BCG
• DPT
• DT,TT,HBV,JE Least

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 FREEZE SENSITIVE

• Aluminum adjuvanted vaccines should not be

frozen. If frozen it desiccates, leads to
decrease in potency and causes sterile
abscess.eg. Hep B, Tseries vaccines, Hib.
• Hep B most freeze sensitive, freezes at – 0.50C
• DPT, TT ,DT freezes at ‐30C.
• Do not keep these vaccines on ice pack.
• Ice pack temp. ‐200C so condition it before
using.
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 FREEZE DAMAGE

Shake test Conditioned ice pack

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 POLICY REGARDING MULTIDOSE AND
RECONSTITUTED VACCINES
• Opened reconstituted multi dose vials of measles
and BCG vaccines must be discarded at the end of
each immunization session or at the end of 4 hours
whichever is earlier
• Opened multi dose vials of DPT, TT, Hepatitis B and
OPV vaccines may be used in subsequent
immunization sessions up to a maximum of 1 month
provided that the vaccines have been stored
properly and the expiry date has not passed

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 CONTRAINDICATIONS FOR VACCINATION

• Anaphylaxis following a previous dose or known

allergic reaction to vaccine component

• Encephalopathy within 7 days of pertussis vaccine

• For some live vaccines – immuno‐suppressed state

• Minor illnesses are not contraindications

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ADVERSE EVENTS FOLLOWING IMMUNIZATIONS
(AEFI)
• An untoward event following immunization that
might or might not have been caused by
immunization
• Types of adverse events:
– Vaccine reaction
– Immunization error
– Anxiety reaction
– Coincidental
• Serious AEFI: Death, disability, hospitalization
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 NATIONAL IMMUNIZATION SCHEDULE

• 1978: EPI ( Expanded program of immunization)

India introduced 6 vaccines‐BCG, DPT, OPV, DT,
TT,
• 1985: UIP (Universal immunization program)
Targeted to immunize all infants with BCG, OPV,
DPT and measles and TT for pregnant women
• Pulse polio program ( National Immunization
Day)
• Hepatitis B is given only in some states currently
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 NATIONAL IMMUNIZATION SCHEDULE
Birth BCG, OPV, Hep B1
6 weeks DTwP1, OPV1, HepB2,Hib*
10 weeks DTwP2, OPV2, HepB3,Hib*
14 weeks DTwP3, OPV3, HepB4, Hib* +IPV
9-12 months Measles / MR, JE1
16-24 months DTwP B1, OPV4, Measles, JE2#
5-6 years DTwP B2,
10 years TT
16 years TT

#JE vaccine given in *Hib vaccine is given as pentavac in

select endemic districts select states

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 PREGNANT WOMEN
•TT1 (early in pregnancy)
•TT2 (1 month later)
•TT booster (if vaccinated in past 3 years)

•Vitamin A
9months,18months then 6 monthly upto 5 yrs total
9 doses

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 IAP IMMUNIZATION SCHEDULE
Age (completed Vaccines
weeks/months/years)
Birth BCG,OPV 0, HepB 1
6 weeks DTwP1,IPV1,Hib1,HepB2
Rotavirus1,PCV 1

10 weeks DTwP2,IPV2,Hib2,
Rotavirus2,PCV 2
14 weeks DTwP3,IPV3,Hib3,
(Rotavirus 3),HepB3
PCV 3

9 months OPV2,MMR1
9-12 months Typhoid conjugate vaccine

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 IAP IMMUNIZATION SCHEDULE ‐ CONTD
Age Vaccines

12 months Hepatitis A
15 months MMR2,Varicella,PCV Booster
16 to 18 months DTwP B1/DTap B1, IPVB1,
Hib B1
18 months Hepatitis A 2

2 years Typhoid 1

5 Years DTwP B2/DTaP B2,OPV3,

Typhoid B,Varicella 2
10 to 12 years Tdap/Td
HPV
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 INDIVIDUAL VACCINES

Vaccines under national immunization program

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 BCG VACCINE
 BCG is a live attenuated vaccine containing bovine
tuberculosis bacilli
 Administered in the newborn period
 Protective against severe forms of child hood TB
( Miliary and meningeal TB)
 50‐80% efficacy
 Can even be given to babies of HIV positive mothers
in newborn period

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 BCG VACCINE ADMINISTRATION

 BCG is supplied as lyophilized powder in dark

coloured multidose ampoules or vials ( to be
protected from light) with diluent
 Reconstituted vaccine dose is 0.1ml: intradermal
route over left deltoid region using tuberculin
syringe and 26G/27G needle
 Following local reaction, scar formation occurs in 6‐
12 weeks

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 ORAL POLIO VACCINE (OPV)

 2 types of polio vaccines were developed in 1950’s:

OPV by Albert sabin and IPV ( Inactivated polio
vaccine‐Injectable) by Jonas Salk
 OPV is used in NIP and also on NIDs
 Contains attenuated polio virus types 1,2 and 3
 Highly heat sensitive
 Immunogenicity less in developing countries;
multiple doses required
 Monovalent OPV – P1 or P3 ( MOPV) and bivalent
OPV ( BOPV) – P1 + P3 in some areas they are more
immunogenic than trivalent OPV
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 ORAL POLIO VACCINE

 OPV given at birth, 6, 10,14, weeks, 16 ‐ 24 months

under NIS
 Also in NIDs (Pulse polio) and SNIDs to break
circulation of wild polio virus
 Orally 2 drops
 Type I 106 Type II 10 5.5 and Type III 10 5.5 doses
 Extremely rare, but serious adverse effects of OPV:
‐ Vaccine associated paralytic polio (VAPP)
‐ Vaccine Derived polio viruses (VDPVs)

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 DIPHTHERIA, TETANUS AND PERTUSSIS
(WHOLE CELL) VACCINE – DTWP
• Contains diphtheria and tetanus toxoids and killed
pertussis bacilli
• 3 primary doses at 6, 10 and 14 weeks and 2
boosters at 16‐24 months and 5 years
• Effectiveness: Diphtheria and tetanus > 95% ;
pertussis 70‐90%
• Tetanus boosters recommended at 10 and 16 years

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 ADVERSE EVENTS FOLLOWING DTWP

• Minor adverse events like pain, swelling, redness at

injection site, fever and irritability in about 50% of
vaccines
• More serious adverse events are rare
• Absolute contraindications:
‐ Anaphylaxis to previous dose
‐ Encephalopathy within 7 days of DTP
• Progressive neurological deficit – relative
contraindication

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 MEASLES VACCINE

• Live attenuated viral vaccine

• Supplied as lyophilised powder in dark coloured
vials with diluent
• Reconstituted vaccine should be discarded after 4
hours
• Dose 0.5 ml: subcutaneous route
• Administered at 9 months of age

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 HEPATITIS B VACCINE
•To prevent chronic HBs Ag carrier state which can lead
to chronic liver problems and mortality in adults
•Available as recombinant HBs Ag ( Hepatitis B surface
antigen) vaccine
•Dose: 0.5ml IM in <18 years of age ; 1ml in > 18 years
•Various schedules are effective ( >95% seroprotection)
‐ Birth, 1 mo and 6 mo (IAP)
‐ Birth, 6 wks, 14 wks
‐ Birth, 6 wks, 10 wks, 14 wks(NIS)
‐ 6 wks, 10 wks, 14 wks
•Birth dose necessary to prevent vertical transmission

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VACCINES NOT UNDER CURRENT NIP
RECOMMENDED BY IAP

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 MMR VACCINE

• Supplied in lyophilised form with diluent

• Each reconstituted dose of 0.5 ml contains live
attenuated measles, mumps and rubella viruses
• Route of administration similar to measles vaccine,
subcutaneous route
• IAP recommends 2 doses:
– 1st dose at 9 months of age
– 2nd at 15months of age

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 HEMOPHILUS INFLUENZAE TYPE B
( HIB) VACCINE
• Hib important pathogen in invasive infections such
as meningitis and pneumonia
• Hib vaccine is a conjugate vaccine; each 0.5ml
contains capsular polysaccharide bound to a protein
(tetanus toxoid or nontoxic mutagenic diphtheria
toxoid)
• Dose 0.5ml IM
• Schedule recommended: 3 doses below 6 months of
age starting at 6 weeks: minimum interval of 4 weeks
between doses; booster at 15‐18 month of age
• Efficacy 90‐100%

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 INACTIVATED POLIO VACCINE (IPV)

 Killed vaccine containing all the 3 types of polio

virus; given by IM injection
 Sero conversion rates are 90‐100% when given
at 6,10 and 14 weeks; a booster dose
recommended at 15‐18 months of age
 IAP recommends combined sequential OPV ,
IPV schedule for best protection and also to
reduce to risk of VAPP
 IPV is to be introduced as single dose at 14
weeks with OPV

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 ACELLULAR PERTUSSIS VACCINE (AP)
 Instead of whole pertussis bacilli, some components
like pertussis toxin, filamentous hemagglutinin and
pertactin are included in the acellular DTaP vaccine
 Dose and age recommendations are similar to DTwP
vaccine
 Minor and major side effects seen with DTwP are
decreased by nearly 2/3 with DTaP
 Absolute contraindications are similar to DTwP
 Cost is a major factor
 DTwP is found to be more efficacious hence now
DTwP recommended for primary vaccination series.
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 TYPHOID VACCINE

 Vi Polysaccharide vaccine and conjugate

typhoid vaccines are available.
 Vi polysaccharide 1st dose given after 2 years
of age; To be repeated every 3. years
 Efficacy 65‐75%
 Typhoid conjugate vaccine may be given at 9
months of age.

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 VARICELLA VACCINE

Chickenpox generally a benign disease in children

↑ complications in neonates, adolescents and adults,
pregnant women and immuno‐compromised
Varicella vaccine; live attenuated virus; lyophilised
powder; to be reconstituted with the diluent
Dose: 0.5ml; subcutaneous
Currently 2 doses are recommended by IAP :
‐ 1st at 15 month of age
‐ 2nd between 4 – 6 years of age

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 HEPATITIS A VACCINE

 Hepatitis infection is relatively benign in young

children <5 years of age and may be asymptomatic in
many
 Hepatitis A can be severe in adults and in those with
underlying chronic liver disease
 Vaccine is formalin inactivated (killed); Dose 0.5ml
IM
 Recently a live attenuated vaccine also available;1ml
per dose IM
 IAP recommends 2 doses at 6‐12 months interval;
starting at > 1 year of age
 Protective efficacy 90‐100%

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 PNEUMOCOCCAL VACCINE
• S.pneumoniae – important cause of death due to severe
pneumonia and bacterial meningitis in children
• 2 Vaccines:
13 valent PCV (Pneumococcal conjugate vaccine)
23 Valent PSV (Pneumococcal polysaccharide vaccine)
• PCV is T cell dependant and immunogenic in children < 2
years
• PCV recommended by IAP for routine immunization‐ 6,10, 14
weeks and booster 15‐18 months; 0.5ml IM
• PSV in special groups after 2 years of age (sickle cell disease,
asplenia, nephortic syndrome)

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 ROTA VIRUS VACCINE

 ROTA virus major cause of severe diarrhea related

mortality in developing countries

 2 live attenuated oral vaccines available:

‐ Human monovalent vaccine ( 2 doses; 1ml
each)
‐ Human bovine reassorted pentavalent vaccine
( 3 doses; 2ml each)
 Schedule: Ist dose 6‐8 weeks (not later than 14
Wks)
Interval between doses 4‐8 weeks
Complete last dose before 32 weeks
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 RABIES VACCINE

 Rabies vaccines currently used are the modern tissue

culture vaccines: Purified chick embryo cell vaccine
(PCEV), Purified vero cell vaccine (PVCV), Human
diploid cell vaccine (HDCV)
Equal efficacy
Post exposure prophylaxis started as soon as possible
Standard protocol (Essen): Days 0,3,7,14 and 30
Dose: 1ml IM ; anterolateral thigh or deltoid muscle
ID route Updated Thai red cross regime 2‐2‐2‐0‐2‐0

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 JAPANESE ENCEPHALITIS (JE) VACCINE

 JE risk is highest in children aged 1 – 15 years and in

rural areas
 Cell culture derived live SA‐14‐14‐2 Chinese vaccine
 Dose 0.5ml subcutaneous, 2 dose 9 months and
18months
 Given to children aged 1‐15 years in selected
districts of UP, Assam, West Bengal, Kerala and
Karnataka

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 HUMAN PAPILLOMA VIRUS (HPV) VACCINE

 Vaccine for prevention of cervical cancer

 HPV types 16 and 18 are responsible for 70% of
cervical cancer worldwide, including India
 2 vaccines available in India – Quadrivalent
(16,18,6,11) and Bivalent (16,18) vaccines
 Protective efficacy 93‐99%
 IAP recommends routine HPV vaccination for girls at
10‐12 years of age
 3 doses : 0,2 and 6 months ( Quadrivalent)
0,1 and 6 months ( Bivalent)
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 THE MYTHS AND FACTS ABOUT
IMMUNIZATION
•The Myth
•Too many vaccines might overload the immune
system
•The Fact
•The immune system can simultaneously respond to
over 10 million antigens at any one time
•Natural infections present more antigens

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 THE MYTHS AND FACTS

• The myth
• Combination vaccines may be less effective than
vaccines administrated separately
• The fact
• The DTPw‐HB‐Hib combination formulations
• Excellent immunological response

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 POINTS TO REMEMBER ‐ IMMUNIZATION

• Vaccines as per schedule as per chronological age in

pre terms and low birth weight babies

• Need not restart even after lapse of usual interval

• Minor illnesses, malnutrition not contra indications

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 POINTS TO REMEMBER ‐ IMMUNIZATION

• Minimum 4 weeks gap between 2 primary doses of

the same vaccine.

• Minimum of 4 weeks gap between 2 live vaccines

• Killed vaccine can be given any time after or before

any vaccine

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 POINTS TO REMEMBER ‐ IMMUNIZATION

• Stick to proper guidelines – dose, route

• Maintain cold chain
• Inform parents about benefits and anticipated
reactions
• Use reconstituted vaccines in 4 hrs
• Disposable – Auto disabled syringe
• Anterolateral thigh or deltoid
• Keep basic resuscitation ready drugs /
equipments

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 SOURCE

• IAP recommendations 2014, IP

• IAP Guide Book on Immunization 2011 by
• IAP Committee on Immunization 2009 ‐2011

• IAP text book of Pediatrics 4th edition

• Editor Dr.A.Parthasarathy

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THANK YOU

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