Cold Chain & Logistics for New Vaccines

A presentation on the logistics and cold chain issues for the new vaccines

WHO/V&B/AVI

Cold Chain & Logistics for New Vaccines



Cold Chain issues

 

What is the capacity of existing cold chain? Does it need to be expanded to accommodate the new vaccines? What plans do you have for expansion/ improvement in your cold chain system? What training needs are there for cold chain? A national cold chain assessment, if conducted, would highlight the above needs
WHO/V&B/AVI

Cold Chain & Logistics for New Vaccines



Cold Chain Assessment

 Many

countries have ageing cold chain equipment  No major reviews of cold chain carried out in the past  New vaccines require additional consideration in the cold chain
increased space requirement special technical consideration (e.g. freezing) new equipment (e.g. new freeze watch)
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Cold Chain & Logistics for New Vaccines



Cold Chain Consideration (for HepB)

Storage volume (cm per dose) 1 dose 2 dose 6 dose 10 dose vials vials vials vials 9.7-14.9 4.8 3.2 3 24.6 8.2 9.7 3 9.7
3

Vaccine HepB monovalent HepB (UniJectTM) DTP+HepB* DTP-HepB (combined) DTP-HepB+Hib

* Monovalent HepB (liquid) in pre-filled single-dose injection device

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Comparison of storage volumes of different formulations

Storage volume (cm3/dose)
25

1-dose
20

in cubic centimetre

2-dose
15

6-dose 10-dose

10

HepB mono

HepB-Uniject

DTP+HepB combo

DTP+HepB+Hib

DTP

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Cold Chain & Logistics for New Vaccines



Cold Chain Consideration (for HepB)  If it is DTP-HepB combined, there is a slight increase in cold chain space requirement than for DTP alone  A DTP-HepB combined has the same volume as that of HepB monovalent. Therefore, if you choose HepB monovalent, your cold chain space requirement doubles  Your cold chain space requirement triples or quadruples if you choose single dose monovalent preparations of HepB
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Cold Chain & Logistics for New Vaccines



Cold Chain Consideration (for HepB), contd..  And your cold chain requirement approximately triples if you choose DTPHepB (liquid) combined in single pre-filled injectable device  The pentavalent also increases your cold chain space requirement roughly by three times than of what you would need for DTP alone
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Cold Chain & Logistics for New Vaccines



Cold Chain Consideration (for Hib)

Packed volume Vaccine
Hib

Presentatiion
liquid, single dose vial liquid, ten dose vial lyophilized, single dose vial liquid, single dose vial liquid, ten dose vial lyophilized, single dose vial with AD syringes lyophilized, 10 dose vial lyophilized, two dose vial lyophilized, 10 dose vial
WHO/V&B/AVI

(cm /dose)
32 9.5-13.8 9.7 32 13.8 154 11.9 9.7 5.3

Hib/DTP Hib/DTP/HepB

Cold Chain & Logistics for New Vaccines



Cold Chain Consideration (for Hib)  A 10 dose DTP/Hib requires a slightly more cold chain space than DTP/HepB, but this requirement more than triples if you choose liquid, single dose Hib  A lyophilized 10 dose vial needs just slightly more space than a 10 dose DTP/HepB, but increases tremendously if you choose lyophilized, single dose with ADs packed together  A lyophilized two dose vial will need double the space than a lyophilized 10 dose vial
WHO/V&B/AVI

Cold Chain & Logistics for New Vaccines



Logistics for the new vaccines

 Once

you have established your cold chain needs, you have to plan for the ordering, receipt & distribution of vaccines  Ensure that your vaccine requirement forecast is correct  Establish your quantity required and the frequency with which supplies will be delivered  By carefully adjusting your vaccine orders, even without increase in your cold chain capacity, you can manage greater amount of vaccine with shorter supply periods.
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Cold Chain & Logistics for New Vaccines



Logistics for the new vaccines, contd..  Know the dates of delivery of your vaccines so that you have in place storage and transport ready  Make sure that your distribution to the regional, provincial and district levels is planned and that all key people are aware of the shipment of the vaccine

WHO/V&B/AVI

Cold Chain & Logistics for New Vaccines



Logistics for the new vaccines, contd..  Ensure that your transport system is in place and functioning prior to your actual receipt of the vaccine  Receive the vaccine, check to ensure that the cold chain was maintained throughout the transport period from the manufacturer to your cold store at national national; reject shipment if evidence of breakdown of cold chaindocument everything for future reference
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Cold Chain & Logistics for New Vaccines



Distribution from the central to regional/ provincial & district stores  The faster you can ship vaccines from central to regional and provincial stores, the easier it will be for you to lessen pressure on cold chain space at the national level  But the regional and provincial level cold stores must be in a position to take care of the vaccine
WHO/V&B/AVI

Cold Chain & Logistics for New Vaccines



Distribution from the central to regional/ provincial & district stores, contd...  Over-stocking at the district & peripheral health facility should be avoided to lessen potential for loss of vaccine due to expiry or failure of cold chain

WHO/V&B/AVI

Cold Chain & Logistics for New Vaccines



Issue of Freezing
freezes at about -5o C, but HepB and its combinations freeze at -0.5o C  Therefore, monovalent HepB vaccine or any of its combination formulation cannot be allowed to reach 00 C or lower at any point of time
 DTP

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Vaccines affected or not affected by freezing

affected by freezing DTPw DTPw combos DTPa DTPa combos Td/TT/dtpa hepatitis B hepatitis A HA/HB; HA/S.typhi
adapted from WHO EPI/LHI/98.02

not affected by freezing OPV measles lyophilised mumps lyophilised rubella lyophilised MR lyophilised MMR lyophilised varicella lyophilised Hib lyophilised

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Stability of commonly used vaccines

vaccine
DT toxoids

+2/8C +22/25C +35/37C >+37C 3-7 yrs 2-4 yrs 2 yrs mths mths 1 mth
50% loss

wks wks >1 wk

20% loss d1-4 50% loss d2-6

45C wks 45C days 41C 50% loss

in 2-3 d 53C days >60C hours

HB Me

54C 80% loss

in 1 day

Pw OPV

1.5-2 yrs 2 wks

some

1 wk
<50% loss

45C
10%loss/day

0.5-1 yr 1-2 wks

some
WHO/V&B/AVI

unstable
potency loss 1-3 d

very unstable

MgCl2 OPV vaccine is more stable than the OPV sucrose vaccine; SBBio OPV can be frozen (2 year shelf-life in frozen form)
adapted from WHO report 1998 Galazka A et al thermostability of vaccines WHO GPV 98/07 pp 63-63-64

Cold Chain & Logistics for New Vaccines



Issue of Freezing, contd..

 And

it is also known that, especially in those top opening refrigerators, there is a gradient or differential temperature from top to bottom- I,e, it is warmer at the top and cooler at the bottom  Therefore, a temperature reading closer to the top may not necessarily indicate the right temperature at the bottom  Anything in contact with the sides and bottom (in ILRs) is likely to freeze
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Cold Chain & Logistics for New Vaccines



What can be done to prevent freezing-some practical tips?

 Reset

any refrigerators so that temperatures can be maintained between +20 C to +80 C  If freezing is likely, set the thermostat of the refrigerator closer to the +80C. If temperature is set around 80C around noon, it is unlikely to reach zero at night.  Stock DTP-HepB or DTP-HepB+Hib or HepB on the lower racks in a front opening refrigerators
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Cold Chain & Logistics for New Vaccinespractical tips---contd/

 Stock

DTP-HepB or DTP-HepB+Hib or HepB in the middle of the pile or closer to the lid in top opening refrigerators  Do not stock anything that should not be frozen at the bottom or in contact with sides of ILRs- keep sufficient space on the sides, use a polystyrene board or wooden pelt at the bottom to prevent vaccines from coming in direct contact (of course, you lose space for this)

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Cold Chain & Logistics for New Vaccinespractical tips---contd/

 Even

if it is a holiday or weekend, make sure that you check your refrigerator temperature at least once a day  Use freeze watch. The previous freeze watch is designed to pop at -40C and when it pops, it stains the absorbing paper red. But the current freeze watch for the new vaccines is designed to pop at 00C and when it pops, the paper is stained dark blue
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Cold Chain & Logistics for New Vaccinespractical tips---contd/



 

If freezing is suspected, try the shake test, always with a never frozen vial as control If freezing seen > DISCARD If freezing suspected > conduct shake test. If sedimentation rate <2 minutes > DISCARD If sedimentation rate >10 minutes, suspected samples will need to be tested for particle size distribution If in doubt (and if vaccine quantity is small) discard, but if quantity is large, then further testing may be necessary: contact your programme incharge for further advice
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Cold Chain & Logistics for New Vaccines



Monitoring vaccine wastage  Because the new vaccines are expensive, it is essential to make every effort to reduce vaccine wastage  Therefore, daily vaccine use and vaccine wasted must be recorded and reported periodically (ideally on a monthly basis) from the health facilities to the next higher level

WHO/V&B/AVI

Cold Chain & Logistics for New Vaccines



Monitoring vaccine wastage  At the national level, at least a quarterly analysis of vaccine wastage should be possible  Any large scale, sudden wastage of vaccine should be investigated

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