Cold Chain & Logistics for New Vaccines

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Cold Chain Logistics for New Vaccines

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

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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

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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)

Monovalent HepB (liquid) in pre-filled
single-dose injection device
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Comparison of storage volumes of different
formulations
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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 DTP-HepB (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)

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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

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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

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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 chain- document
  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

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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

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Cold Chain Logistics for New Vaccines

• Issue of Freezing
• DTP 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

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Vaccines affected or not affected by freezing
affected by freezing DTPw DTPw combos DTPaDTPa
combos Td/TT/dtpa hepatitis B hepatitis A HA/HB
HA/S.typhi
not affected by freezing OPV measles
lyophilised mumps lyophilised rubella
lyophilised MR lyophilised MMR lyophilised varicel
la lyophilised Hib lyophilised
adapted from WHO EPI/LHI/98.02
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Stability of commonly used vaccines
adapted from WHO report 1998 Galazka A et al
thermostability of vaccines WHO GPV 98/07 pp
63-63-64
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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-HepBHib or HepB on the
  lower racks in a front opening refrigerators

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Cold Chain Logistics for New Vaccines-practical
tips---contd/

• Stock DTP-HepB or DTP-HepBHib 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 Vaccines-
practical 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 Vaccines-
practical tips---contd/

• If freezing is suspected, try the shake test,
  always with a never frozen vial as control
• If freezing seen gt DISCARD
• If freezing suspected gt conduct shake test. If
  sedimentation rate lt2 minutes gt DISCARD
• If sedimentation rate gt10 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
  in-charge 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

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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