Cold Chain preparation for introduction of new vaccines

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• Cold Chain preparation for introduction of new
  vaccines

TECHNET 2008 Consultation Tunis, Tunisia, 2 - 4
December 2008 S. Kone WHO/IVB/EPI
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Vaccines pipeline
Potential vaccines
HIV/AIDS
Malaria
TB
HPV
Next generation
Pneumococcal
General scientific/technical certainty
Typhoid
Available underutilized
Rotavirus
Cholera
Meningococcal A
Influenza
JE
HepB
YF
Traditional EPI
Polio
Measles
Tetanus
Year/anticipated year of introduction
1960
1980
2000
1970
1990
2010
Size of circle indicates number of deaths
(400,000 deaths, 2002 data) Left side of circle
aligned with expected introduction date
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Operational characteristics for vaccines

• Formulation (liquid or lyo.)
• No. of doses to fully immunize (contacts)
• Presence of Preservative (Y/N)
• Mode of administration (oral or injectable)
• Storage conditions (temperatures, VVM, )
• Presentation (mono/multi-dose)
• Packed volume (cm3/dose)
• Packaging of diluents (if any)
• Price (/dose)

Formulations
Presentations
Cost
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Assumptions for vaccine volume calculations

• Vaccines packed volumes (cm3/dose) from
• WHO Guidelines on international packaging
  shipping of vaccines (WHO/IVB/05.23)
• Manufacturer data
• Similar vaccines (formulation presentation)
• Vaccine wastage rates
• Lyophilized vaccines
• 50 for 20-dose vials
• 40 for 10-doses vials
• Liquid vaccines
• 25 for 10-dose vials
• 10 for 2-dose vials
• 5 for single-dose

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Interpretations

• Net vaccine volume per child will be divided by
  No. of shipments (2 4)
• Gross capacity per child of the vaccine store
  will be divided by grossing factor of WICR (3.2
  4.2)
• ?Gross capacity of the vaccine store should be
  equal to net annual volume of vaccines

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Pneumococcal Conjugate Vaccine

• Formulation administration Liquid vaccine for
  IM injection only
• Schedule 3 doses (lt1year)
• Storage temp. (2 - 8C), DO NOT FREEZE!
• Type of VVM - none
• First presentation Prevnar PCV-7
• One box of 10 pre-filled syringes with needle to
  be bundled!
• Storage volume per dose 55.9cm3
• Future presentation PCV-10
• Two-doses vial (Q1 ?, 2010) 12.9cm3

Syringe with vaccine
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Rotavirus vaccines
RotaTeq vaccine presentation
Rotarix vaccine presentation

• Liquid vaccine for ORAL administration
• Schedule 3 doses (lt1year)
• Storage conditions temp. 2 - 8C, protect
  from light
• Type of VVM-???
• Initial presentation (volume/dose)
• Box 1 single-dose vial 146.0cm3/dose
• Box 10 single-dose vials 85.0cm3/dose
• Optimized presentations (volume/dose)
• Boxes of 25 single-dose vials 48.0cm3

• Lyophilised vaccine to be reconstituted with
  liquid diluent for ORAL administration
• Schedule 2 doses (lt1year)
• Storage conditions temp. 2 - 8C, DO NOT
  FREEZE!, protect from light
• Type of VVM-14
• Initial presentation (volume/dose)
• Box of 10 single-dose vials (applicators with
  diluents, bag of transfer adapter and box of
  vials of vaccine) 156.0cm3
• Optimized presentations (volume/dose)
• Box of 25 single-dose vials (w. dil.) 110.6cm3
• Box of 25 single-dose vials (w/o dil.) 11.0cm3
• Box of 25 single-dose diluents 88.5cm3

Applicator with diluent
Vaccine vial
Transfer adapter
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Current anticipated vaccines volumes per child
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Estimated cold chain for new vaccines
Potential vaccines
HIV/AIDS
Malaria
TB
HPV
Next generation
Pneumococcal
General scientific/technical certainty
National cold chain capacity (cm3/child)
Typhoid
Available underutilized
Rotavirus
Cholera
Meningococcal A
Influenza
JE
HepB
YF
Traditional EPI
Polio
Measles
Tetanus
Year/anticipated year of introduction
1960
1980
2000
1970
1990
2010
Size of circle indicates number of deaths
(400,000 deaths, 2002 data) Left side of circle
aligned with expected introduction date
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National vaccine store capacity Global
TVPentaPCV single-dose vialRota (349.1
cm3/child)
6/8 countries
TVPentaPCV prefilled syringe (248.1 cm3/child)
2/6 countries
4/6 countries
TVPentaPCV single-dose vial (112.3 cm3/child)
32/36 countries
4/6 countries
Source Country cold chain data are from GAVI
applications, EVSM assessment reports, Stock
Management Tools
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Challenges of vaccine transportation
Example of a province of 3,400,000 inhabitants

• No. of shipments to the Province is increased
  from 4 to 6 per year!
• No. volume/weight of cold boxes to be
  transported, will be 2.5 to 5 times more, not
  including injection equipment
• Ice making requirements will increase accordingly
• Packaging repackaging, definitely more complex.

• End of ad-hoc distribution/collection
• Need to reassess use of refrigerated vans
• Need to explore outsourcing of distribution

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Challenges for outreach

• Need for bigger lighter vaccine carriers to be
  prequalified (PQS)!!!

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Options to reduce cold chain

• Some options
• Presentation trivial switch from mono-dose to
  multi-dose
• Packaging increasing number of vials
  minimizing dead spaces in packaging
• Combination from mono to multivalent vaccines
• Stability to allow handling vaccines out of the
  cold chain

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Vaccine presentation

• Relate to primary packaging
• Obvious increase of packed volume from mono to
  multi-dose presentations

• Issues to be managed
• preservative issue
• wastage more problematic

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Vaccine packaging

• Increase quantities per secondary packaging (from
  single-vial pack to 10 vial packaging)
• Reduce the packed volume
• More complex repackaging for in-country
  distribution
• Minimizing dead spaces
• Optimal design for vials (ampoules vs vials????)
• Tight packaging in boxes and cartons

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Vaccine combination

• Reduced packed volume expected
• Minimized workload
• Stock inventory (recording, handling, )
• Service delivery (less injections)
• More convenient!
• Production challenges
• Compatibility
• Vaccine efficacy

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Efforts to address challenges

• Development of cold chain logistics tools
• For country decision-making, planning
  implementation (VVC, CCEM, CCCPT,
  EPI-Log-Forecasting Tool, ...)
• To undertake required cold chain
  assessments/analysis for NVI (GAVI applications)
• Implementing effective vaccine management
• 4 nat. stores certified (Oman, Moldova,
  Afghanistan Sudan)
• Assessing vaccine management at all levels (VMA)

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Conclusion

• There are numerous potential new introductions by
  2013, and more upstream vaccines also coming on
  line
• Preparing the cold chain will require
• Speeding scaling up efforts to improve all
  components of cold chain management
• Adopting new policies for storing and handling
  vaccines, out-of-cold chain, freeze prevention,
  etc.

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Conclusion

• Tools are available
• immediate in the context of GAVI applications
• short mid terms anticipate (cMYP ideal frame
  work)
• Radical implication for logistics managers
  training
• Increasing complexity and costs of logistics will
  require (a) recruitment and (b) serious
  qualification improvement of logistics managers
  at all levels!
• Anticipated increasingly complex policy structure
  TLAC, OPTIMIZE,
• Cold chain will remain a challenge for new
  vaccine introduction Not a constraint!

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Thank you
Hib Liq
Good luck !!!
Hep B
Many more coming !
Pneumo conj
DT/TT/Td
Rotavirus
DTaP combos
IPV
Measles
OPV
Hep A
Influenza
Rubella
JE PHK
Cholera/ Typhoid Live
Cholera/ Typhoid Killed
Hib Lyo
MMR
Men conj
Yellow Fever
DTP-HepB
JE mouse brain
DTP
Rabies
BCG
Varicella
HPV
Influenza
Men PS