Cold chain system and adverse effects following immunisation

1. COLD CHAIN SYSTEM AND
ADVERSE REACTION
FOLLOWING IMMUNIZATION
(AEFI)
DR. MANOJ KUMAR R
Pediatric Jr.

2. The Cold Chain
• The "cold chain" is a system of storage and
transport of vaccines at low temperature
from the manufacturer to the actual
vaccination site.
• The cold chain system is necessary
because vaccine failure may occur due to
failure to store and transport under strict
temperature controls.

3. Why have the Cold Chain?
If vaccines are exposed to excessive
They lose their potency
Heat
Freezing
Light

4. In general
• All Vaccines lose potency on exposure to
heat above +80 C
• Some Vaccines lose potency when
exposed to freezing temperatures
• The damage is irreversible

5. Cold chain Equipment
Walk in freezers
Walk in coolers (WIC)
Deep freezers
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• ILR-Basket
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Dial Thermometer
Cold boxes
Vaccine carriers
Day carriers

6. Cold Chain Equipment: Various Levels
–State
Refrigerator
Truck
Walk-in Freezer
Walk-in Cooler

7. Cold Chain Equipment: District
Level
Cold Box
Deep Freezer (DF) 300 ltr
Ice-Lined Refrigerator(ILR) 300 ltr

8. Cold Chain Equipment: Unit Level
Ice-Lined Refrigerator(ILR) 140 ltr
Deep Freezer (DF) 140 ltr
Cold Box
Vaccine Carriers

9. 1. Walk-in Cooler & Freezer
Walk-in Cooler
(+2o C to +8o C)
Walk-in Freezer
(-15o to -25o C)

10. Walk-in-Freezers (WIF)
• used for bulk storage of OPV, and also to
prepare frozen ice packs at state stores.
• Maintain a temperature around (-) 20oC.
• available in sizes of 16.5 Cum. and 32
Cum.
• Provided with two identical cooling units
and standby generator.
• installed in all of the states
• Serves 4-7 districts

11. Walk-in-Coolers (WIC)
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used for bulk storage of vaccines at State and
Regional/Divisional Stores.
maintain a temperature of +2oC to +8oC.
Available in sizes of 16.5 Cum. and 32 Cum.
used for storage of large quantities of vaccines, like
DPT, DT, TT, Measles, BCG, Hepatitis B
also provided with temperature recorder and alarm
WIC/WIF store vaccines of three months requirement
and 25% buffer stock for the districts they cater.
Cater 4-5 districts
3 deep freezers and 10 cold boxes.

12. •
•
•
•
Vaccine delivery vans
Transportation of vaccines
from Regional centers to
districts
From districts to PHCs
Temperature maintained at
+2o to +8o C.
2. Refrigerated Truck

13. 3. Ice-Lined Refrigerator
(ILR)
Size: 300 ltr / 140 ltr
Level: District (300 ltr) / PHC (140 ltr)
Temperature: +2˚C to +8˚C
Utilization: BCG, DPT, OPV, Measles, TT,
Hep-B vaccine
Holdover time: 24 hrs after 8 hrs
continuous power supply
Storage capacity:
300 ltr: 60,000 doses of mixed antigen &
20,000 doses of OPV
140 ltr : 25,000 doses of mixed antigen &
18,000 doses of OPV*
* OPV and Measles for 1 month
only. Store in DF if longer than a
month

14. Right way of keeping vaccines
in ILR
• Keep all vaccines in baskets
• Avoid placing vaccines at bottom
of ILR. (never diluents, freeze sensitive)
•
•
Leave space between the
vaccine boxes
Place a thermometer in the
center of the ILR.
Same vaccines in same area.
•
• Diluent / freeze sensitive/ Closer expiry
date vaccines on top
•Heat sensitive / Further expiry date
vaccines in the bottom of basket

15. 4. Deep Freezer (DF)
Size: 300 ltr / 140 ltr
Level: District (300 ltr) / PHC (140 ltr)
Temperature: -15o to -25o C
Utilization:
1. Preparation of ice packs
2. Storing measles and OPV (only
district)
Holdover time: 24 hours with 8 hours
supply
Storage capacity:
300 ltr: 150, 000 to 200, 000 doses
140 ltr : Approx. 20 Ice Packs

16. Do’s for Deep freezer and ILR
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Make one person responsible for loading, unloading,
maintenance and temperature recording.
Install it in a cool and well ventilated room.
Place them at least 10-20 cm away from the wall.
Insure that it is LEVELLED.
Let the electrician fix the cable permanently inside the
socket.
Use voltage stabilizer
Tape the switches in ON position so that there s no
accidental switching off.

17. Contd…
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•
•
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Check the temperature at least every morning and
evening.
Adjust the thermostat knob if the temperature is not
correct.
Note the expiry date of all vaccines.
Clean and dry the chamber before loading.
Keep the lid locked.
Place the ILR and deep freezer in the same room.

18. Donts for deep freezer and ILR
• Do not open the lid too often..
• Do not store other drugs
• Don’t keep drinking water or food
• Don’t keep more than one month supply
• Don’t keep outdated Vaccines
• Don’t fill ice packs to the top.
• Don’t keep ILR and deep freezer hugging
together.

20. The Cold Chain Room
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•
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ILRs and deep-freezers to be installed in a room that
is
– Not directly exposed to sunlight or any other
source of heat.
–Ventilated and protected from rain or flooding.
ILR and deep-freezers should be level, on wooden
blocks, at least 10 cms away from wall
The plugs should be permanently fixed & labeled “DO
NOT REMOVE”
Equipment should be locked and opened only if
necessary
Keys to the equipment should be accessible

21. 5. Cold Boxes
Size: 20 ltr and 5 ltr
Level: District / PHC
Temperature: +2˚C to +8˚C
Utilization: All vaccines can be stored for
transportation or in case of power failure
Holdover time: 5 days (20 ltr) and 3 days (5
ltr) if unopened
Storage capacity:
20 ltr: 52 Ice Packs & 6000 doses of mixed
antigens
5 ltr: 20 Ice Packs & 1500 doses of mixed
antigens

22. • Cold boxes. For transportation.
• Fully frozen packs at the sides and bottom
• Vacs in polythene bags
• DPT, DT, TT & diluents not to be kept in
direct contact with frozen ice packs
• Vaccine carriers: 4 frozen packs at the
sides.
• For small quantities

23. 6. Vaccine Carriers
Size: 1.7 ltr
Level: PHC/ Sub Centre
Temperature: +2˚C to +8˚C
Utilization: All vaccines can be
carried in small quantity for
vaccination sessions
Holdover time: 12 hours
Storage capacity: 4 Ice Packs &15-
20 vials of mixed antigens

24. 7. Ice Packs
Size: 763 X 90 X 33
mm Ice capacity: 360 ml
Weight: 80 gm
Level: District / PHC/ Sub Centre
Temperature: +2˚C to +8˚C
Utilization: line the walls of
vaccine carrier/cold box
Time to Freeze: 48 hours in Deep
freezer at - 20˚C

25. 8. Foam Pads
Material: Soft Foam
Thickness: 30 mm with at least 6
incisions
Utilization:
•temporary lid for unopened
vaccines inside the carrier
•surface to hold, protect and keep
cool opened vaccine vials

26. Preparing icepacks for use:
Filling and Freezing
• Fill icepacks with water to mark
• Fit the sealing plug and screw on the lid
tightly
• Hold each ice-pack upside down and
squeeze it to make sure it does not
leak.
• Place the icepacks in the deep freezer.
• Ice-packs need not be refilled every
time they are used. The same water
can be used repeatedly.
• Do not use saline water for filling

27. Preparing icepacks for use:
Conditioning
• On the session day, take
the frozen ice-packs you
•
need from the freezer and
place on a table
Allow ice-packs to sweat at
•
room temperature for 15
minutes
Shake the ice pack to listen
to melted for water.
A Conditioned an ice-pack

29. Vaccines vulnerable to heat
BCG (after reconstitution)
OPV
Measles
DPT
BCG (before reconstitution)
DT
TT
Hep B

30. Vaccines vulnerable to
Freezing
Hep- B
DPT
DT
TT

31. Vaccine Vial Monitor (VVM)
The square is lighter than the circle.
If the expiry date is
not passed, use the vaccine
The square is lighter than the circle.
If the expiry date is not
passed, use the vaccine
The square matches the circle.
Do not use the vaccine.
Inform your supervisor
The square is darker than the circle.
Do not use the vaccine.
Inform your supervisor

32. Summary of Vaccine
Vulnerabilities
Vaccine Heat Light Freezing Temperature
at PHC
OPV
(live attenuated)
Sensitive Sensitive Okay to freeze +2˚C to +8˚C
(-15˚C to -25˚C at
state, regional and
district stores)
Sensitive Sensitive +2˚C to +8˚C
BCG
(live attenuated)
Measles
(live attenuated)
Sensitive Sensitive
Okay to freeze (before
reconstitution)
Okay to freeze (before
reconstitution)
+2˚C to +8˚C
(-15˚C to -25˚C at
state, regional and
district stores)
DPT
(toxoid, killed)
Relatively
heat stable
Freezes at -3˚C. Discard
if frozen.
+2˚C to +8˚C
Hep B
(recombinant)
Relatively
heat stable
+2˚C to +8˚C
TT
(toxoid)
Relatively
heat stable
Freezes at- .5˚C.
Discard if frozen.
Freezes at -3˚C. Discard
if frozen.
+2˚C to +8˚C

33. AEFI
Definition:
Adverse event following immunization is any
untoward medical occurrence which follows
immunization and which does not necessarily
have a causal relationship with the usage of
the vaccine.

34. Adverse Effect Following Immunization (AEFI)

35. Types of AEFIs by severity and frequency
• 1. Common minor AEFIs
• 2. Severe AEFIs
• 3. Serious AEFIs

36. • Common minor AEFIs: A vaccine induces immunity by causing the
recipient‟s immune system to react to the vaccine.
• Therefore, local reaction, fever and systemic symptoms can result as
part of the immune response.
• In addition, some of the vaccines components (e.g. adjuvant,
stabilizers or preservatives) can lead to reactions.

37. • Severe AEFIs and serious AEFIs: An AEFI will be considered serious if
it results in death, requires hospitalization, results in persistent or
significant disability/ incapacity or a cluster (two or more cases) of
AEFIs occur in a geographical area.
• AEFIs that are not minor but do not result in death, hospitalization or
disability are categorized as severe.
• Severe‟ is used to describe the intensity of a specific event (as in
mild, moderate or severe). The event itself, however, may be of
relatively minor medical significance.

38. COMMON, MINOR REACTIONS
* Rate of local reactions likely to increase with booster doses, up to 50-85%
** Symptoms include diarrhoea, headache, and/or muscle pains
Vaccine Local reaction
(pain, swelling, redness)
Fever
>38oC
Irritability, malaise &
systemic symptoms
BCG 90-95% - -
Hib 5-15% 2-10% -
HepB Adults: 15%; Children: 5% - 1-6%
Measles/
MMR ~10% 5-15% 5% rash
Polio
(OPV)
- <1% <1%**
Tetanus ~10%* ~10% ~25%
DTP
(pertussis)
Up to 50% Up to 50% Up to 55%

39. RARE, MORE SERIOUS REACTIONS
Vaccine Reaction Onset
interval
Rate per million
doses
BCG Suppurative lymphadenitis 2-6 months 100-1000
BCG osteitis 1-12 months 1-700
Disseminated BCG 1-12 months 2
Hib Nil known
Hep B Anaphylaxis 0-1 hour 1-2
Guillain Barré syndrome 1-6 weeks 5
Measles
/MMR
OPV
Febrile seizures
Thrombocytopaenia
Anaphylaxis
Vaccine-associated paralytic
poliomyelitis (VAPP)
Risk is higher for first dose, adults,
and immunocompromised
5-12 days
15-35 days
0-1 hour
4-30 days
333
33
1-50
0.76-1.3 (1st dose)
0.17 (subsequent
doses)
0.15 (contacts)

40. RARE, MORE SERIOUS REACTIONS (2)
1000-60 000
570
570
20
0-1
0-24 hours
0-3 days
0-24 hours
0-1 hour
0-3 days
Persistent (>3 hrs)
inconsolable screaming
Seizures
Hypotonic, hyporesponsive
episode (HHE)
Anaphylaxis/shock
Encephalopathy
DPT
Nil extra to tetanus reactions
Tetanus-diphtheria
5-10
1-6
6-10
2-28 days
0-1 hour
1-6 weeks
Brachial neuritis
Anaphylaxis
Sterile abscess
Tetanus
Rate per
million doses
Onset
interval
Reaction
Vaccine

41. RARE, MORE SERIOUS REACTIONS (3)
Vaccine Reaction Onset interval Rate per million
doses
Japanese Serious allergic reaction 10-1000
encephalitis
Neurological event 1-2.3
Yellow fever Post-vaccination Encephalitis
Allergic reaction/anaphylaxis
7-21 days
0-1 hours
500-4000 in
infants<6 months
5-20

42. Reporting
• The reporting of serious/severe AEFI is done using Case Reporting Format
(CRF) (formerly First Information Report)
• which is prepared by the Medical Officer of the PHC or the reporter and
then sent to the District Immunization Officer within 24 hours of getting the
information of the case.
• In the next 24 hours, the DIO verifies the case details and sends it
simultaneously to the state and national level.
• The CRF gives only the most basic details of the affected person, vaccines
and session details and status at the time of filling the format.

43. • The other channel of reporting serious and minor AEFI from the level of
occurrence of the AEFI up to the national level is through monthly progress
reports.
• This is done using existing monthly immunization reporting formats such as
the ones for National Rural Health Mission (NRHM), Health Management
Information system (HMIS) etc.
• It is necessary for the peripheral health staff to submit a NIL monthly report
in case no AEFI is detected from their area during the month.
• Minor AEFI that are brought to the notice of the health staff as a concern
should be reported and documented in a linelist.

45. AEFI Form

46. THANK YOU….