Immunity : 4

1. Adverse Effect Following

Immunization(AEFI)
2. National Immunisation Schedule
3. Cold Chain
4. Mission Indra Dhanush

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 Technicalities
in
Vaccination
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 IMMUNOSUPPRESSION CONDITIONS

Disease conditions

• Congenital immunodeficiency
• Leukemia or lymphoma
• Generalized malignancy
• Chemotherapy
• Taking Alkylating agents
• Anti metabolites
• Radiation
• Corticosteroids
- >20 mg per day
- >2 mg/kg per day
- Not aerosols, topical, alternate day, short courses
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 TECHNIQUE OF VACCINE ADMINISTRATION
Needle size
22-25g 1-2” DTwP / DTaP, Hib, Hep A, Hep B, DTwP-Hep B-
Hib, DTwP-Hep B, DTwP-Hib, Hep A-Hep B

23-25g 5/8” MMR, Meningococcal, Varicella , Measles

Route
Intradermal BCG
Subcutaneous Measles, MMR, Meningococcal, Varicella,
Intramuscular DTwP / DTaP, Hib, Hep A, Hep B, DTwP-Hep B-
Hib, DTwP-Hep B, DTwP-Hib, Hep A-Hep B

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 TECHNIQUE OF VACCINE ADMINISTRATION - SITE

At Deltoid Vaccinations for BCG

At Triceps area For Measles, MMR, Meningococcal,

(Posterior skin fold) Varicella

At Vastus lateralis (anterolateral For DTwP / DTaP, Hib, Hep A, Hep B,

aspect of thigh in infants) DTwP-Hep B-Hib, DTwP-Hep B,
DTwP-Hib, Hep A-Hep B

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 Do’s and Don'ts After Vaccine Administration

• Do not rub the site vigorously.

• Gentle pressure at the site for a few seconds will suffice.
• If blood oozes do not blot. Just apply gentle pressure with
cotton swab.
• No Heat, Ice or Cold Water fomentation is advocated.
• The wet cloth soaked in ordinary portable water can be applied
at the site of swelling or tenderness for about 5 – 10 minutes.
• Repeat the procedure, if necessary, 3-4 times a day.

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 CONTRAINDICATIONS AND PRECAUTIONS

• Contraindication for vaccinations

– A condition in a recipient which greatly increases the
chance of a serious adverse reaction.
• Precaution during vaccinations
– A condition in a recipient which may increases the chance
or severity of an adverse reaction, or
– May compromise the ability of the vaccine to produce
immunity
• Permanent contraindications to vaccination:
– Severe allergic reaction to a vaccine component or
following prior dose
– Encephalopathy within 7 days of pertussis vaccination

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 THE FUTURE OF VACCINATION

• Newer vaccines will be mostly in combination formulation

• Novel ways in vaccine delivery systems will be evident..
• Newer technologies for vaccine administration
• Vaccine vial monitors to check the integrity in cold chain
• Integrated disease surveillance system
• Elimination and eradication of VPD’s in a phased manner
• Vaccines in patches, to replace syringes and needles
• Only 4 vaccines in combination formulation to prevent 43 VPD’s
instead of the existing 23 antigens

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 SELECT FUTURE VACCINES
• HIV vaccine
• Rota virus vaccine
• ETEC vaccine
• Shiegella vaccine
• New cholera vaccine
• Malaria vaccine
• New streptococcus
• pneumoniae vaccine
• New influenza vaccine
• Chlamydia trachomatis
• Schistosomiasis
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• Dengue illness
• New Japanese B encephalitis
• Neissaria Meningitidis
• Hepatitis C
• Hepatitis E
• Helicobacter pylori
• Ebstein Barr virus
• New Measles vaccine
• Group A streptococcus
• Group B streptococcus
• Leptospirosis
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 Future combination in vaccines

• Enterotoxic E Coli-Typhoid-RV-HepA
• ETEC-Typhoid-Cholera-Shigella
• ETEC-Typhoid-Cholera-Shigella-Campylobacter
• Campylobacter-Salmonella-Helicobacter
• Hep A-HepB-Rota Virus -ETEC
• HEP A-HepB-Helicobacter

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 Administration of Aluminum salt as adjuvants in vaccines

• Alu.salt has been successfully used as adjuvant without any

significant adverse effect.
• vaccines must be injected, deep in the muscular mass.
otherwise can cause local irritation, inflammation, granuloma
formation and necrosis.
• aluminium salt adjuvanted vaccines like DTwP, DTaP, DT, dT,
Hep B and Hep A should not be frozen for fear of desiccation
of the aluminium saltwhich can result otherwise in ‘STERILE
ABSCESS’ formation.
• Hence ‘Shake test’ is mandatory

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 Adverse Events following Immunisations (AEFI)

All vaccines are extremely safe but sometimes not perfectly safe &
adverse reactions are rare, but do occur .

Definition: AEFI
is an untoward medical occurrence which follows
immunisation and does not necessarily have casual relationship
with the usage of the vaccine.

Classification: Vaccine product related reaction., Vaccine quality defect

related reaction, Immunisation error related reaction, Immunisation anxiety
related reaction ,Coincidental events.

AEFI :Frequency wise: very common > 10%, Common (1-10%), Uncommon
(0.1 to 1.0%) very rare 0.01%

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 VACCINE ADVERSE REACTIONS

• Adverse reaction • Local

– Extraneous effect caused – Pain, swelling, redness at site of
injection
by vaccine – Common with inactivated
– “side effect” vaccines
• Adverse event – Usually mild and self-limited
– Any event following • Systemic
– Fever, malaise, headache
vaccination
– Nonspecific
– May be true adverse – May be unrelated to vaccine
reaction • Allergic
– May be only coincidental – Due to vaccine or vaccine
component
– Rare
– Risk minimized by screening

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 AEFI
Clinically with : local reactions, systemic reactions, allergic reactions.

Reporting:

Any one who comes across such AEFI must report it to local health
authorities either as monthly routine reporting or on immediate serious
AEFI notification.

1. Serious AEFI: death, hospitalization, cluster symptoms , disability.

2. Signal and event associated with a newly introduced vaccine.
3. AEFI reporting: Regarding immunisation error related reaction
4. Significant event of unexplained cause within 30 days of immunisation

5. Event causing significant parentral or community concern.

All reported AEFI are investigated by specialists .

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 FAQ’s by Parents on Immunization

• If my child misses the primary schedule – What to do?

• Are booster doses necessary for all vaccines?
• Are Cough, Cold, Mild fever, Loose motions – contra-
indications for immunization?
• Is it necessary to give MMR, Hep B, Hib, Hep A and Varicella
vaccine also to my child?
• Will extra doses of Polio drops administered during NID’s be
harmful to the child?
• What vaccines we should give for older children/adolescents?
• Should we adults also take some vaccines?
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 National Immunisation Schedule
• NIS: Current aim is to prevent 10 diseases: They are tuberculosis,
measles, diphtheria, pertusis, tetanus, poliomyelitis, Hepatitis B,
H. influenzae B, mumps and rubella ,thr. i .e. BCG,DPT, OPV, HBV,
HiB, IPV,PCV,rotavirus and MR.
• They are offered by GOI free of charge. Though many useful
vaccines have been left out from universal immunisation due to
cost factors.
Differences in sch. of vaccines on IAP recommendations are:
• 1. Five additional vaccines varicella vac, HAV and typhoid vaccine
for routine immunisation are suggested by IAP.
• IAP recommends 2 doses of MR at 9 & 15 m. instead of 9 m. dose
• IAP recommends Tdap > 7 yrs. for missed 5 yr booster dose
• IAP also recommends other 7 vaccines for selective use like for
influenza, meningococci, JE, cholera, rabies, yellow fever
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 IS P)
N N IA
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(N

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 Importance of cold chain

1. Vaccines properties :
• They are biological product.
• They loose the potency, over the time.
• Process of deterioration in quality is irreversible and
accelerated if proper storage conditions are not adhered to.
2. To assure potency in vaccine product and vaccine program
It is a Professional responsibility Ensure that the vaccine will be effective. It
might derange health planning
• Public Health Responsibility: Raising Public confidence in immunisation
program
3. Ensuring maximum benefits from immunisations programs.
• Responsibility is of not wasting the scarce NHS resources
• And also to reduce wastage to service providers from human errors.
4. Compliance with manufacturer
• Any vaccine that has not been stored at a temp. of 2-8 degree C. as per its
licensing conditions , the vaccine is no longer a licensed one.
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 COLD CHAIN SYSTEM

Requirements: Safe Zones :

Short tem storage 2-8 degree C.,
Long term storage : -20 degree C(not for DTwP / DTaP )
BCG. , measles, MMR, varicella, & rotavirus vaccines
are sensitive to light exposure.

Cooling Tools : walk in coolers, Deep freezers, ice lined refrigerators &
refrigerators.
Dial thermometer :
Vacc.should be kept in freezer compartment to keep them cool in
power failures..
Vaccine carriers or isothermic boxes: To carry small amount of vaccines.

Vaccine Vial monitoring, and random collection of vaccine samples from

field sites for laboratory potency testing of vaccines are part of the
monitoring .
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 Requirements of Cold Chains at:

Manufacturer Point

Distributor’s point

Vaccine depot

Stockist/ Provider’s office

Patient/ point of admini

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 Cold Chain Flowchart

Vaccine Vaccine Vaccine arrival at Vaccine storage

manufacturing and handling at Vaccine
distribution provider facility administration
provider facility

Manufacturer Provider
Manufacturer/ responsibility
responsibility
distributor
responsibility

If the cold chain is not properly maintained,

vaccine potency may be lost,
resulting in a vaccine made useless.
 Vaccines can be damaged by

• Freezing
• Exposure to
– Heat
– Sunlight Light- UV rays
– Fluorescent /neon light.
 Equipments

1. For storage of vaccines

2. For transportation
of vaccine
Stationary Vaccine Storage
Cold Chain
Equipments

Walk
Walk in
in cold rooms
cold rooms

Deep freezers
Deep Freezers

Ice
Ice Lined Refrigerators
lined refrigerators

Deep
Deep Refrigerators
Refrigerators
 WIC (walk in coolers) DF (deep freezers)
ILR (Ice lined refrigerator)
COLD CHAIN
DR (deep refrigerator)
EQUIPMENTS

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 (ICE LINED REFRIGERATORS .ILR)
(BUFFER in case of power failures)

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 Tips for safe vaccine storage
in domestic refrigerator

• Use a dedicated vaccine fridge

• Proper placement of refrigerator
• Restrict accessibility of refrigerator
• Avoid accidental disconnection of the power source
• Stabilize the refrigerator temperature before stocking-
• new/after repair
• Place ice packs/gel packs in freezer
• Place water filled plastic containers in lower drawer and door.
• Minimum opening of the door.

First in - first out policy

 Storage Devices
Walk in Freezer -20˚C National & Regional stock reserve

Walk in Cold room 2˚C to 8˚C Manufacturer –sorting, packing,

unpacking
Deep Freezer -15˚C to -25˚C At DHQ & PHC

Ice Line Refrigerator 2˚C to 8˚C At DHQ & PHC

2˚C to 8˚C Pharmacy ,Big hospitals, Paed

Purpose built clinics
refrigerator

Dome. refrigerator -4˚C to 0˚C Paediatric/GP clinics

4˚C to 10˚C
Isothermal box 2˚C to 8˚C Transport for outreach area
Storing of vaccines during -
maintenance/breakdown
 ILR
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Ideal Storage Method
Vaccine storage equipments
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Use of Vaccine Placement Map..
Increase the cool mass
Vaccine Transportation
Cold Storage
Equipments

Cold Boxes

Vaccine Carriers

Day Carriers

Ice Packs
 Equipments for outreach areas

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 Transportation equipment for periphery

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 Temp. maintenance devices

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 Thermometers

Dial therm.

Fluid-filled biosafe
thermometer

Max.-Min. Therm
Digital Therm, Alarm
Remote Max.-Min. Thermometer

 Double probe

 Records ext.& int. temp.

 Give information of both

minimum & max. temp.

 Used for continuous
monitoring.
 Dry battery

 Cost: Rs: 6000

Continuous Monitoring Digital Thermometer

 Single probe

 Conti. Display of temp.

 Doesn’t give information of

past
 Used for a continuous

monitoring
 DC power

 Cost: Rs: 2400- 2700

Spot Check Digital Thermometer

 Single probe

 Digital temp. display.

 Doesn’t give information

of past
 Mainly used for a spot

check
 Dry battery

 Cost: Rs: 2200-2400

Regular Temp. Monitoring & Logging

• Temperature readings AM & PM

• Track coolest and warmest

locations

• Plot on a chart to show high/low

excursions

• Keep charts to check history

 Manual Temperature Monitoring

• On receipt of vaccines
• Daily before vaccination commences and at the end of the
working
• Use charts in supervision to motivate
• Keep charts to check history
• Thermometer should be placed in a central location within the
storage compartment.
• Thermometer probe can be placed inside vaccine packaging or
back of an enclosed plastic container
 Light sensitivity of Vaccines
Vaccines sensitive to strong light, sunlight,
ultraviolet, fluorescents (neon)

BCG
MMR Always store
Varicella the vaccines in

Most DTaP containing vaccines their original packing

until point of use
HPV
Rota virus vaccine
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To Safeguard the power supply
 Vaccines damaged by freezing

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 VACCINE COLD CHAIN – IV
Vaccine vial monitor (VVM)-I
• A Vaccine Vial Monitor (VVM) is a label containing
a heat sensitive material which is placed on a
vaccine vial to register cumulative heat exposure
overtime
• The inner square (2 mm) is the indication, which is
light at starting point than the outer circle (7mm)
and becomes darker with exposure to heat
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VACCINE COLD CHAIN – V
Vaccine vial monitor
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 Power Failure:
1st Record the time & Refrigerator Temp

Situation Action

Power failure of ≤ 4 hours keep vaccines in the

Power failure of ≥ 4 hours
If power failure of ≥ 4
hours & no back-up
generator/fridge
refrigerator & keep the door
closed
identify an available unit &
shift the vaccines.
store vaccines in a insulated
container
with icepacks & store in
fridge
 VACCINE COLD CHAIN
Do’s and Don’ts

• Do not freeze the following vaccines: If frozen to be

discarded after ‘Shake Test’
• Aluminium salts when frozen desiccate which may
cause ‘sterile abscess’
– Diphtheria-tetanus-pertussis containing vaccines
– Haemophilus influenza type B
– Hepatitis B containing, Hepatitis A containing vaccine
– Influenza vaccine, Pneumococcal vaccine
– Meningococcal C conjugate vaccine
– Japanese encephalitis vaccine
– All reconstituted, All combinations of these vaccines
– Vaccine diluents
 VACCINE PREVENTABLE DISEASES SURVEILLANCE
Points to Remember

• Surveillance: watch with attention, suspicion and authority

• National Polio Surveillance Project (NPSP)
- Targets 2005: Wild Polio Virus Interruption: 2008 Polio Eradication
• Acute Flaccid Paralysis (AFP) Surveillance and Polio Case Detection
by Virological Confirmation
- Regions where indegenous wild virus is in circulation
- Regions where wild virus interruption is achieved
- Regions where imported virus is detected
• NID’s strategies revised : NID’s for the whole country : SNID’s
regions wise
• Integrated Disease Surveillance Programme (IDSP)
• Reporting of VPD to local health authority / Central IAP
 Mission Indradhanush

It is launched in 2014 by GOI., with objective to ensure full or >90%

immunisation of children below 2 years.
The seven colours of rainbow targets to immunise against 7 VPD. :
tuberculosis, diphtheria, pertusis, tetanus, polio, hepatitis B, and
measles, along with H . Influenzae B , and japanese encephalitis

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 Constraint in success of vaccination program in India.

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 FAQ’s by Parents on Immunization

• If my child misses the primary schedule – What to do?

• Are booster doses necessary for all vaccines?
• Are Cough, Cold, Mild fever, Loose motions – contra-
indications for immunization?
• Is it necessary to give MMR, Hep B, Hib, Hep A and Varicella
vaccine also to my child?
• Will extra doses of Polio drops administered during NID’s be
harmful to the child?
• What vaccines we should give for older children/adolescents?
• Should we adults also take some vaccines?
07/15/2023 vcp 75
 Key messages

All health services should have a written vaccine cold

chain protocol.
The protocol should cover the knowledge of the staff
for cold chain, delivery and breach protocols, vaccine
fridge requirements, vaccine fridge monitoring and
maintenance, managing light sensitive vaccines,
power outages, refrigerator failure and mobile and
emergency vaccine storage.
Use the checklist to help to develop a cold chain
protocol.

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