Universal Immunization Program

Objectives

• After completing this unit, you should be able to:

• Explain evolution of immunization program
• Describe National immunization schedule
• Explain open vial policy and its rationale
• Discuss Mission Indradhanush and its relevance
• Enlist various vaccines under UIP
• Explain cold chain
• Discuss and recognize various adverse effects following immunization
• Explain the reasons of the low coverage
Introduction

• Immunization is the process whereby a child is made immune or resistant to an

infectious disease by the administration of a vaccine
• It helps protect the child from life threatening disease
• Government of India launched the Universal Immunization Program (UIP) in 1985
• National Vaccine Policy was revised in 2011 with a goal to guide decision making in
order to develop a long term plan to strengthen the UIP
Universal Immunization Program

• Objectives
▪ To rapidly increase immunization coverage
▪ To improve the quality of services
▪ To establish a reliable cold chain system to the health facility level
▪ Monitoring of performance
▪ To achieve self sufficiency in vaccine production
Universal Immunization Program

• Scope and Eligibility

▪ India has one of the largest Universal Immunization Programs (UIP) in the world in
terms of the quantities of vaccines used, number of beneficiaries covered, geographical
spread and human resources involved
▪ Under UIP, all the vaccines are given free of cost to the beneficiaries as per the
National Immunization Schedule
▪ All beneficiaries’ namely pregnant women and children can get themselves vaccinated
at the nearest Government/Private health facility
▪ The UIP covers all sections of the society across the country with the same high quality
vaccines
Universal Immunization Program
• Achievements
▪ The biggest achievement of the immunization program is the eradication
of small pox
▪ One more significant milestone is that India is free of Poliomyelitis caused
by Wild Polio Virus (WPV) since march 2014
▪ Besides, vaccination has contributed significantly to the decline in the
cases and deaths due to the Vaccine Preventable Diseases (VPDs)
• The goal of Universal Immunization Programme is to fully immunize each
child i.e. give BCG, 3 doses of Pentavalent vaccine, 3 doses of OPV, 3 doses
of RVV, 2 doses of IPV, 3 doses of PCV and Measles Rubella 1st dose before
1 year of age and Measles-Rubella 2nd dose, DPT Booster 1 and OPV
Booster before 2years of age.
Vaccines Under UIP
• BCG (Bacillus Calmette Guerin)
• DPT (Diphtheria, Pertussis and Tetanus Toxoid)
• OPV (Oral Polio Vaccine)
• fIPV (fractional IPV)
• Measles-Rubella (MR)
• Hepatitis B
• Td (Tetanus diphtheria)
• JE (vaccination in selected high disease burden Districts).
• Hib containing Pentavalent vaccine (DPT+HepB+Hib)
• RVV (Rotavirus Vaccine)
• PCV (Pneumococcal Conjugate Vaccine)
Diseases Protected by Vaccination under UIP
• 1. Tuberculosis • 8. Diarrhoeas due to rotavirus
• 2. Hepatitis B • 9. Pneumococcal disease
• 3. Polio • 10. Measles
• 4. Diphtheria • 11. Rubella
• 5. Pertussis • 12. Japanese Encephalitis
• 6. Tetanus
• 7. Haemophilus Influenzae Type B
related diseases (bacterial meningitis,
pneumonia and others)
National Immunization Schedule

Vaccine Due Age Max Age Dose Diluent Route Site

For Pregnant Women

Td-1 Early in Pregnancy Give as early 0.5 ml NO Intra- Upper Arm
as muscular
possible in
pregnancy
TT-2* 4 weeks after TT-1* - 0.5 ml NO Intra- Upper Arm
muscular

TT Booster If received 2 TT - 0.5 ml NO Intra- Upper Arm

doses in a pregnancy muscular
within the last 3
years
 National Immunization Schedule
Vaccine Due Age Max Age Dose Diluent Route Site
For Infants
BCG At Birth Till one year of (0.05 ml until 1 YES Intra- Left Upper Arm
age month) 0.1 ml (Sodium dermal
beyond age 1 Chloride)
Month
Hepatitis B- Birth At Birth Within 24 0.5 ml NO Intra- Antero-lateral
Dose hours of birth muscular side of mid-thigh

OPV-0 At Birth Within the first 2 drops NO Oral Oral

15 days of life

OPV-1,2 & 3 At 6 weeks, 10 Till 5 years of 2 drops NO Oral Oral

weeks and 14 age
weeks
Pentavalent 1,2 & 3 At 6 weeks, 10 1 year of age 0.5 ml NO Intra- Antero-lateral
(Diphteria+ weeks and 14 muscular side of mid-
Pertusisi+Tetanus+ weeks thigh-Left Leg
Hep B+ Hib)
 National Immunization Schedule
Vaccine Due Age Max Age Dose Diluent Route Site

For Infants
Fractional IPV At 6 and 14 1 year of 0.1 ml NO Intra- Right Upper
(Inactivated Polio completed weeks age dermal Arm
Vaccine)
Rotavirus Vaccine At 6 weeks, 10 weeks 1 year of 5 drops NO Oral Oral
and 14 weeks age

Pneumococcal At 6 weeks & 1 year of 0.5ml NO Intra- Anterolateral

Conjugate Vaccine 14 weeks. At 9 age muscular side of
(PCV) Completed months mid-thigh
Booster - RIGHT
Measles / At 9 5 years of 0.5 ml YES Sub- Upper Arm -
Rubella 1st completed age Manufacturer cutaneous RIGHT
dose months-12 Supplied diluent
months. (Sterile water)
 National Immunization Schedule
Vaccine Due Age Max Age Dose Diluent Route Site
For Infants
Measles / At 9 5 years of 0.5 ml YES Sub- Upper Arm -
Rubella 1st completed age Manufacturer cutaneous RIGHT
dose months-12 Supplied diluent
months. (Sterile water)
JE-1 @ (Where At 9 months- 15 years of 0.5 ml YES Sub- Upper Arm -
applicable) 12 age Manufacturer cutaneous LEFT
months Supplied diluent
(Phosphate
Buffer
Solution)
Vitamin A At 9 months 5 years of 1 ml - Oral Oral
(1st dose) age (1 lakh
IU)
National Immunization Schedule

Vaccine When to give Max Age Dose Diluent Route Site

For Children
DPT Booster-1 16-24 7 years of 0.5 ml NO Intra- Anterolateral
months age muscular Side of mid-
thigh
– LEFT
Measles / 16-24 5 years of 0.5 ml YES Manufacturer Sub- Upper Arm -
Rubella 2nd months age Supplied diluent cutaneous RIGHT
dose (Sterile water)
OPV Booster 16-24 5 years of 2 drops NO Oral Oral
months age
JE–2 @ (Where 16-24 till 15 years 0.5ml YES Manufacturer Sub- Upper Arm -
applicable) months of age Supplied diluent cutaneous LEFT
(Phosphate Buffer
Solution)
National Immunization Schedule

Vaccine When to give Max Age Dose Diluent Route Site

For Children

Vitamin A $ At 16 months. up to the 2 ml - Oral Oral

(2nd to 9th dose) Then, one dose age of 5 (2 lakh
every 6 months. years IU)

DPT Booster-2 5-6 years 7 Years of 0.5 ml NO Intra - muscular Upper Arm
age

TT 10 years & 16 16 years 0.5ml NO Intra – muscular Upper arm

years
Vaccines under UIP

• BCG Vaccine
▪ Live attenuated, freeze dried bacterial vaccine
▪ Dose is 0.05 ml till one month of age; after one month till one year of age the dose is
0.1 ml
▪ The diluent is normal saline; vaccine comes in a ten dose vial, so one ml of diluent is
added to vial to make ten doses. Used within 3-4 hours of reconstitution
▪ Administered intra-dermal, in left arm, just above the deltoid, with a 26 Gauge needle
and 0.1 to 1ml syringe
▪ Try not to touch the injection site. There would be a papule at the injection site within
2–3 weeks, which will turn into a nodule by 5–6 weeks
Vaccines under UIP

• No need to revaccinate the child even if there is no scar formation

• Contraindicated in immune-compromised persons, patient on immune-suppressive
therapy, patients suffering from generalized eczema, infective dermatosis and
pregnancy
• Adverse effects
▪ Minor reactions: local pain, swelling and tenderness etc.
▪ Rare serious adverse reactions

Do not clean the injection site with anti-septic, as it may affect the
vaccine efficacy
Vaccines under UIP
• Diptheria, Pertussis and Tetanus (DPT) Vaccine
▪ A combined vaccine which protects against three diseases viz., diphtheria, pertussis and
tetanus
▪ It comes as a liquid preparation, ready for use, sterile, whitish turbid, uniform suspension of
diphtheria toxoid, tetanus toxoid and inactivated whole cell Bordetella pertussis bacilli
▪ It usually comes in a 5 ml vial, with 10 doses of 0.5 ml each
▪ DPT 1st booster: is given at16–24 months
▪ DPT 2nd Booster: is given 5 years; 0.5 ml.I/M Upper Arm
▪ Contraindicated in infants and children having high fever or acute illness, presence of
neurological disorder, older children (> 6 years )and adult and also child with history of
severe reaction when administered earlier
Vaccines under UIP

• Tetanus Diphtheria (Td) Vaccine

▪ Children: 10 years & 16 years 0.5 ml I/M Upper Arm (under the NIS)
▪ Pregnant females: first pregnancy: two doses of Td are given, one month apart (first
dose early in pregnancy, second dose 4 weeks apart)
▪ In subsequent pregnancy within three years of first pregnancy, give just one booster of
Td
▪ If the subsequent pregnancy occurs after three years, then two doses of Td vaccine are
given
Vaccines under UIP

• Measles Rubela Vaccine

▪ Live attenuated, freeze dried vaccine
▪ Vaccine comes in a 5 dose vial, each dose is 0.5 ml. Diluent is distilled water
▪ First dose is given at 9 months of age, administered subcutaneous at the right arm,
while second dose at 16–24 months
▪ Contraindicated in high grade fever or severe illness, pregnancy, immune-
compromised persons
▪ Adverse effects
✔ Local reactions: Pain, redness and swelling
✔ Systemic adverse effects: Toxic shock syndrome occur if the vaccine gets contaminated
Vaccines under UIP

• Poliomyelitis Vaccine (Bivalent oral polio vaccine)

▪ Live viral vaccine contains types 1 & 3 polio virus (Sanin strains)
▪ Comes in a vial of 20 doses (20ml) and two drops are given orally
▪ Primary three doses at 6, 10 & 14 week and one booster dose at 16–24 month of age
is given orally
▪ Apart from UIP, bOPV is also given on Supplementary Immunization Activities
(SIAs) in children 0–5 years of age to interrupt transmission of polio virus
▪ Adverse effects: no side effects in majority
▪ Contraindicated in primary immune deficiency disease or suppressed immune
responses from medication, leukemia, lymphoma or generalized malignancy
Vaccines under UIP

• Poliomyelitis Vaccine (Inactivated (Salk) polio vaccine)

▪ Killed viral vaccine, contains antigens against all the three strains. It induces humoral
immunity
▪ Under the NIS, only one dose is at 14 weeks along with third dose of OPV. This
single dose is for risk mitigation
▪ For immunization with IPV, total 4 doses are required; 3 doses at 4 to 8 weeks
interval, followed by booster after 6–12 months after last dose
▪ This vaccine can be given in persons with immunodeficiency disorders, over 50 years
of age and in pregnancy. There is no risk of Vaccine derived paralytic polio
Vaccines under UIP

Hepatitis B Vaccine
• About – Hepatitis B vaccine protects from Hepatitis B virus infection.
• When to give- Hepatitis B vaccine is given at birth or as early as possible within
24 hours. Subsequently 3 dose are given at 6, 10 and 14 weeks in combination
with DPT and Hib in the form of pentavalent vaccine.
• Route and site- Intramuscular injection is given at anterolateral side of mid thigh
Vaccines under UIP

Pentavalent Vaccine
• About-Pentavalent vaccine is a combined vaccine to protect children from five
diseases Diptheria, Tetanus, Pertusis, Haemophilis influenza type b infection and
Hepatitis B.
• When to give - Three doses are given at 6, 10 and 14 weeks of age (can be given
till one year of age).
• Route and site-Pentavalent vaccine is given intramuscularly on anterolateral side
of mid thigh
Vaccines under UIP

JE vaccine
• About- JE stands for Japanese encephalitis vaccine. It gives protection against
Japanese Encephalitis disease. JE vaccine is given in select districts endemic for JE
after the campaign.
• When to given- JE vaccine is given in two doses first dose is given at 9 completed
months-12 months of age and second dose at 16-24 months of age.
• Route and site- Live attenuated vaccine is given as subcutaneous injection in left
upper arm and killed vaccine is given as intramuscular injection in anterolateral
aspect of mid- thigh
 COLD CHAIN
• COLD CHAIN is a system of storing and transporting vaccines at recommended temperatures
from the point of manufacture to the point of use.

The Cold Chain System

COLD CHAIN – Key Elements
Equipment
To store and
transport vaccines
and to monitor
temperature Procedures
Personnel To ensure that
To manage vaccines are stored
vaccine storage and transported at
and distribution appropriate
temperatures

Key Elements
Over view of Cold Chain Equipment
Cold Chain

• Walk in Freezer
▪ Big insulated rooms, (one can actually walk in) to maintain
temperature 0 to – 20°C
▪ Used for storing OPV and frozen ice packs for long term
• Deep freezers
▪ For maintaining temperature between –15°C to –25°C
▪ Used for making ice packs
 Cold Chain
• Ice lined refrigerator
▪ Maintain a temperature of + 2°C to +8°C
▪ Used to store vaccines at PHC level.
▪ Due to presence of ice lining, they maintain temperature even if there
are electricity failures
▪ Used to stock up Vaccines for 3 months
▪ BCG, OPV, IPV, RVV, DPT, TT, Measles/MR, Hep-B , Penta, IPV
• Cold boxes
▪ Insulated boxes of 5–20 liter capacity.
▪ Maintain a temperature of + 2°C to +8°C
▪ Used for transportation and emergency storage of vaccines and ice
packs
Cold Chain
• Vaccine carriers
▪ With 4 frozen ice packs, it maintain a temperature of + 2°C to
+8°C for 12 hours

• Ice packs
▪ Plastic containers filled with water
▪ These are frozen in the deep freezers and when placed in non-
electrical equipments such as vaccine carriers and cold boxes,
they maintain temperature and increase hold over time
 Open Vial Policy
• Open Vial Policy (OVP) allows reuse of partially used multi-dose vials of applicable
vaccines under the UIP in subsequent sessions (both fixed and outreach) up to 4 weeks
(28 days) subject to meeting certain conditions
• This policy contributes to the reduction of vaccine wastage

Open Vial Policy Yes No

Vaccine Hep B, OPV, DPT, Pentavalent, Td, BCG, MR, RVV, JE

PCV and IPV
• Only those diluents that are provided with the vaccine by the manufacturer should be used
• Keep diluents in an ILR at +2°C to +8°C at least 24 hours before use to ensure that the
vaccine and diluent are at the same temperature when being reconstituted
• Keep diluents with the vaccines in plastic zipper bag inside the vaccine carrier during
transportation
Thermo-sensitivity of Vaccines

Vaccines sensitive to heat Vaccines sensitive to freezing

• BCG (after reconstitution) Most Most

• OPV
• IPV • Hep B
• Measles, MR • PCV
• Rotavirus • Penta
• JE • IPV
• DPT • DPT
• BCG (before reconstitution) • Td
• Td Least
Least
• Penta, Hep B, PCV
Checking Vaccines for Correct Maintenance of Cold Chain
• Vaccines need to be checked both for damage from excessive heat as well as from freezing

• However, the physical appearance of a vaccine may remain unchanged even after it is damaged

Checking vaccines for heat damage

• Vaccine Vial Monitor (VVM) is a label containing a heat sensitive material to record cumulative
heat exposure over time

• The combined effect of time and temperature cause the inner square of the VVM to darken
gradually and irreversibly. Before opening a vial, check the status of the VVM

• If the VVM shows change in colour to the end point, then discard the vaccines.
 Cont.

Fig. Checking the

vaccines for heat
damage
 Cont. Shake test - Control vial
• Take a vaccine vial of the same antigen, same manufacturer, and same batch
number as the suspect vaccine vial you want to test.
• Freeze solid this vial at -20°C overnight in the DF, and this is the ‘CONTROL’ vial
Shake test - Test vial and label accordingly to avoid its usage.

• Take a vaccine vial you • Let it thaw. Do NOT heat it.

• Hold the Control and the Test vials together between thumb and forefinger, and
suspect that may have been vigorously shake the vials for 10-15 seconds.

frozen – This is “TEST” • Place both vials to rest on a flat surface, side-by-side and observe them for 30
minutes.
vial. • Compare for rate of sedimentation.
• If the sedimentation rate in the ‘Test vial” is slower than in the “Frozen vial”, the
vaccine has not been damaged, it has passed the shake test. Use the vaccine batch –
it is not damaged.
• If the sedimentation rate is similar in both vials or if sedimentation is faster in the
“Test” vial than in the “Frozen” vial, the vaccine is damaged, it failed in shake test.
Do NOT use. Notify your supervisor.
 Cont..

Vaccines returned from RI session should be kept in separate and clearly marked bags/containers as per the
guidelines

Vials that are expired, frozen or with VVM beyond the end point, should not be placed in the cold chain as
they may be confused with those containing potent vaccines.

Vials from suspected AEFI cases must be clearly marked in separate bags / containers.
Dos and Dont’s in cold chain and vaccine sensitivities
Dos
• Keep all vaccines in ILR at +2°C to +8°C
at PHC
• Use diluent provided by the manufacturer
with the vaccine
• Keep diluents in ILR at +2°C to +8°C at
least 24 hours before use
• Use reconstituted Rotavirus vaccine, BCG,
Measles/MR and JE vaccine within 4 hours
• Discard all damaged vials for disinfection
and disposal
Don’ts
• Do not keep in the cold chain:
▪ Expired vials,
▪ Frozen vials or
▪ Vials with VVM beyond the end point
• Do not use Rotavirus vaccine or
reconstituted BCG, JE and Measles/MR
vaccines after 4 hours.
• Do not dispose damaged or empty vials in
the village or surroundings of the session
site
Thermometers

• Either dial or stem (alcohol) are used to

monitor temperature in cold chain equipments
• Recordings of temperature are taken every
morning and evening
• Records are maintained and corrective action is
taken if the recorded temperature is outside the
recommended range
Adverse Events following Immunization

• Vaccine reaction
▪ An event caused or precipitated by the active component or one of the other components of
the vaccine. This is due to the inherent properties of the vaccine
• Program Error
▪ An event caused by an error in vaccine preparation, handling or administration
• Coincidental
▪ An event that occurs after immunization but is not caused by the vaccine. This is due to a
chance association
• Injection Reaction
▪ Event from anxiety about, or pain from the injection
• Unknown
• Common minor vaccine reactions
Reasons for Low Immunization Coverage

• Failure to provide immunization at planned outreach, sub-center or PHC sites

• Dropouts Children who receive one or more vaccination, but do not return for subsequent
doses
• Unreached populations
• Children whose parents do not know about immunization or face socioeconomic barriers to
utilize services
• Lack of geographic access: Children who live too far away from a health center or outreach
site to realistically complete a full immunization schedule
• Resistant populations: Children whose parents do not believe in immunization services,
even though a health center is within reach
• Missed Opportunities: Children who visit the health center for some other reason, but are
not screened for immunization by health workers
Calculating the Beneficiaries per Month for each Vaccine

• If monthly target for a village is 1 infant and 1 pregnant woman, then the
beneficiaries for each vaccine (and injection load) for such a village be:
▪ TT = Monthly target of pregnant women x 2 doses (2 injections)
▪ BCG = Monthly target of infants x 1 dose (1 injection)
▪ DPT = Monthly target of infants x 5 doses# (5 injections)
▪ bOPV = Monthly target of infants x 4 doses##
▪ HepB = Monthly target of infants x 3 doses (3 injections)
▪ Measles = Monthly target of infants x 2 doses (2 injections)
▪ JE = Monthly target of infants x 1 dose (1 injection)

Thus, a total of about 14 injections are required for a target of each infant per
month
Calculation for the vaccine vial requirements for a month
Requirement of vaccine vials per month
• TT/BCG/DPT/HepB = Beneficiaries/month × 1.33*
10
On specific need, add calculations of
beneficiaries for doses:
• OPV-0 = Monthly target of infants x
1 dose

• OPV = Beneficiaries/month × 1.33* • HepB-Birth = Monthly target of

infants x 1 dose
20
• TT-10 = expected 10 yr old
• Measles/JE = Beneficiaries/month × 1.33* population x 1 dose
• TT-16 = expected 16 yr old
population x 1 dose
5

* Vaccines = 25% wastage rate or 1.33 WMF (Wastage Multiplication Factor)

Injection Safety and Waste Disposal

• Unsafe injection practices can harm the recipient of the injection, the health worker
and the community
• May lead to life threatening infections like HIV/AIDS, Hepatitis B and C
• Trainings are conducted and supported by job-aids
• Follow strictly Central Pollution Control Board (CPCB) guidelines for biomedical
waste disposal
• The principles followed are:
▪ Segregation of waste at source (at the session site)
▪ Transportation to the PHC or CHC
▪ Treatment of sharps and potentially bio-hazardous plastic waste
▪ Disposal of sharps in sharp pits and treated plastic waste through proper recycling
1. Injection Safety and Waste Disposal
Model Questions

1. Name Vaccines under Universal Immunization Program

2. Name the disease protected under Universal Immunization Program
3. BCG is a …………………………..
4. List key element of cold chain
5. Explain vaccine vial monitor
6. Explain vaccine reaction
7. Write common minor vaccine reactions
References

1. K. Park, Preventive & Social Medicine, 23rd edition, M/s Banarsidas Bhanot Publisher, 2015
(689,803-805)
2. James F. McKenzie, Robert R. Pinger & Jerome E.Kotecki, An introduction to Community Health, 4th
edition, Jones & Bartlett Publisher (556-559)
3. Sridhar Rao, Community Health Nursing, 1st edition, AITBS publisher, 2014, India (357-377)
4. AH Suryankantha, Community Medicine with recent advances, 3rd edition, 2014, Jaypee Brothers
Medical Publisher (213-214)
5. J Kishore, A Textbook for Health workers & Auxiliary Nurse Midwife, 2 nd edition (2016), century
publications (114-198)
6. Janice E Hitchcock, Phyllis E. Schubert &Sue A. Thomas, Community Health Nursing caring in
action, 2nd edition (2003), Thomson Delmar learning (196, 913-14)
7. Dash Bijayalakshmi, A comprehensive textbook of community health nursing, Jaypee brothers medical
publishee,1st edition(673-696)
THANK YOU