Post00386 PROTECTION OF MORE COLD SENSITIVE VACCINES 23 October 2001
CONTENTS
1. PROTECTION OF MORE COLD SENSITIVE VACCINES
" Hep B freezes at ?0.5, two degrees above DPT. ....field assessments in
recent years have shown that DPT freezing is a common problem,..."
It has been said before, though some denied it: The ball was dropped...
... years ago.
Bob Davis, UNICEF, rightly suggests that it be picked up!
" Bill Gates will, quite rightly, kick our collective rears if he discovers
that we have been sitting on this problem for years and talking about it
instead of taking corrective measures, which we have yet to do. Our friends
in surveillance will scratch their collective heads if they cannot
reproduce, from GAVI recipient countries, the same satisfying results in
morbidity reduction which they have documented in DCs, simply because GAVI
countries are giving frozen vaccine."
John Lloyd, PATH/CVP, points out" The risk of freezing has been heavily
underlined by the data coming out of the PATH 'out of the cold chain' trial
in progress in Indonesia. As you say, Hep B vaccine supplied by the Vaccine
Fund is at serious risk of freezing in the cold chain."
John goes on to state that "we need to prepare for the 'beyond the cold
chain' & 'freeze-safe' & 'monodose vaccine' era by reviewing the priorities
expressed in the specifications that WHO laid down in the second half of the
last century."
" 21st century priorities are:
1) to avoid freezing vaccines - most 'WHO' equipment places vaccine at the
risk of freezing
2) to minimise energy consumption - so that solar/grid hybrid becomes
economic
3) to maximise portability and robustness - to assure safe distribution and
retrieval for repair work on fridges"
HiB vaccine and almost all new vaccines can be damaged by freezing.
* Action?
Replies to: [[email protected]][email protected][/email] or use your reply button!
___________________________________________________________________________
From: [[email protected]][email protected][/email]
Sent: dimanche, 7. octobre 2001
To: [[email protected]][email protected][/email]
Subject: PROTECTION OF MORE COLD SENSITIVE VACCINES
Umit Kartoglu
WHO/Geneva
Dear Umit and other colleagues,
PROTECTION OF MORE COLD SENSITIVE VACCINES
This note is to get the ball rolling on a discussion that we should all have
started two years ago.
We now have $281 million worth of GAVI provided vaccines delivered or in the
pipeline for eastern and southern Africa. The global total, all regions, is
about $610, and likely to rise when this month's GAVI applications and
resubmissions, totaling 40, pass committee review on the 25th of this
month.
Almost all of these vaccines contain cold sensitive hepatitis B vaccine.
This makes more urgent the question of whether EPI should, on a global
basis, return to the 4 to 8? recommended refrigeration range of the 1980s.
There are several persuasive arguments in favor of such a change:
Hep B freezes at ?0.5, two degrees above DPT. Since field assessments in
recent years have shown that DPT freezing is a common problem, this will be
true, a fortiori, for Hep B. Hep B does not, it appear, work well with the
shake test. This is the information which Smithkline supplied to Philippe
Duclos about their product. If true with other suppliers' products, it
leaves us with no technical means to detect freezing of vials at the point
of use (the Freezewatch measures the ambient, not the vial. Moreover, until
the blue Freezewatch indicators become universal, the old red ones will
produce false negatives for Hep B). The low temperature VVM is at least
years away. Today's VVM was 15 years in the pipeline. We have known for
decades that accurate morning and evening temp recording, when done, tells
us nothing about nighttime temperatures, which are always lower, especially
in plateau areas and in places using top opening Vestfrosts (most of India)
and Electrolux top openers.
Bill Gates will, quite rightly, kick our collective rears if he discovers
that we have been sitting on this problem for years and talking about it
instead of taking corrective measures, which we have yet to do. Our friends
in surveillance will scratch their collective heads if they cannot
reproduce, from GAVI recipient countries, the same satisfying results in
morbidity reduction which they have documented in DCs, simply because GAVI
countries are giving frozen vaccine.
The ideal solution is a low temperature VVM, on which GAVI might want to
spend Window 3 money. I know that industry has to date shown no interest.
Could PATH take this on? By copy, I am asking Suomi Sakai to get this item
put on the next GAVI Board meeting agenda, as a matter of urgency.
In the meantime, we are stuck with no effective monitoring tools for vaccine
vials containing Hep B. Am I correct in believing that the only possible
short term solution to protection of hep B vaccine is to move the
recommended range back up to 4 to 8?? If this were done, would it be a
global recommendation, or should the main polio reservoirs be exempted for a
year or two? Most of these countries are not yet using hep B, since GAVI has
been slow to given Window 2 funding to major reservoirs.
I do not see that we have any justification, other than institutional
conservatism, not to recommend returning to the 4 to 8 standard.
Best Regards,
Bob Davis
---
From: [[email protected]][email protected][/email]
Sent: mercredi, 17. octobre
To: [email=]'[email protected][/email]'; [[email protected]][email protected][/email]; [email=]'[email protected][/email]';
'[email protected]'; [email=]'[email protected][/email]'
Subject: RE: PROTECTION OF MORE COLD SENSITIVE VACCINES
Robert, Umit,
The risk of freezing has been heavily underlined by the data coming out of
the PATH 'out of the cold chain' trial in progress in Indonesia. As you say,
Hep B vaccine supplied by the Vaccine Fund is at serious risk of freezing in
the cold chain.
I am copying your message to Michael Free at PATH who I think will reply
that we have been trying for several years to find a 'VVM-freezewatch'
technology without success to date. The prospects are so poor of finding
this technology that I doubt that Michael will promise much for the
foreseeable future.
Nor will the problem disappear if we return to a storage standard of 4 to 8
C. Icepacks currently melt at freezing point and may spend many hours below
freezing if used fresh from the freezer - around 10% of the liquid vaccine
in a good cold box will be frozen this way. Refrigerators simply cannot be
regulated to stay in that range. Michael will tell you of wondrous new
eutectic and insulation technologies that will solve this problem however,
and we should pursue this route for the future. That is where some R&D money
might be well spent.
Out of the cold chain might seem to be another solution...but the early data
from Indonesia seem to suggest that wholesale removal from the cold chain
will not work for HepB unless air conditioning is provided...which is more
problematic maintenance -wise than refrigerators! Unfortunately, freezing
takes place at most levels of the cold chain, thanks to the Ice Lined
Refrigerator and the thermostat-less kerosene refrigerator. So it is hardly
possible to specify certain levels 'out of the cold chain'and not others.
In the meantime, we need to review the temperature monitoring equipment that
we have been recommending for the last 20 years and see if there are now
better options to recommend for each level of the cold chain. Then we have
to sensitize health workers and storekeepers to the freezing risk,
particularly for Hep B vaccine, and warn them of risky practices.
All the best,
John
---
From: "Lloyd"
To: , , ,
,
Subject: Freeze-safety and WHO equipment performance standards
Date: Thu, 18 Oct 2001
More on this subject (for Allan's Forum why not?):
It occurs to me that we need to prepare for the 'beyond the cold chain' &
'freeze-safe' & 'monodose vaccine' era by reviewing the priorities expressed
in the specifications that WHO laid down in the second half of the last
century.
Current, 21st century priorities are:
1) to avoid freezing vaccines - most 'WHO' equipment places vaccine at the
risk of freezing
2) to minimise energy consumption - so that solar/grid hybrid becomes
economic
3) to maximise portability and robustness - to assure safe distribution and
retrieval for repair work on fridges
These priorities can be met by high efficiency solar/grid hybrid
refrigeration systems and high-temperature eutectics more easily,
efficiently and economically (per litre storage space) than the current
'vaccine-specific' cold chain equipment
It is no longer a priority to:
1) Have a long hold-over time in refrigerators - because vaccines have VVMs
and are quite stable
2) Freeze water icepacks - that put vaccine at risk
3) Have a long cold life for vaccine carriers - because VVMs permit 'beyond
the cold chain'
4) Promote absorption refrigeration where there is little or no
electricity - now that solar/grid hybrid is competitive - and better!
Let us start to re-think our priorities for specifying cold chain equipment,
both refrigerators and vaccine carriers/cold boxes. That way, we can meet
the priorities of the future and lay the priorities of the past to rest.
All the best,
John
---
Subject: Re: Freeze-safety and WHO equipment performance standards
To: [[email protected]][email protected][/email];aylwardb.unicef.org, [[email protected]][email protected][/email], [[email protected]][email protected][/email],
[email protected], [[email protected]][email protected][/email], [[email protected]][email protected][/email], [[email protected]][email protected][/email],
[email protected],
[email protected], [[email protected]][email protected][/email]
From: [[email protected]][email protected][/email]
Date: Fri, 19 Oct 2001
Dear All,
Given the problems of protecting cold sensitive vaccines, one could think
of a WHO/UNICEF recommendation that vaccine refrigerators be set at 8
degrees at noon (or the hottest time of the day) so as not to fall below
zero at night. A notice to this effect could be placed on newly procured
refrigerators supplied through the agencies.
This would require no change in current EPI policy, but would simply be a
way of insuring that the current policy is properly implemented.
Cheers,
Bob Davis
___________________________________________________________________________
These Technet Forum Postings discussed the freezing of freeze sensitive
vaccines and related issues and technologies.
They are available for download. See file download details below.
DATE POST
10-Nov-98 Post0074 LOW TEMPERATURE PROTECTION
27-Jan-99 Post0102 LOW TEMPERATURE PROTECTION
2-Feb-99 Post0104 LTP
16-Feb-99 Post0111 T-ZONES LTP
19-Feb-99 Post0113 T-ZONES AND LTP
25-Feb-99 Post0116 T-ZONES & LTP
26-Feb-99 Post0117 T-ZONES & LTP
12-Mar-99 Post0123 T-ZONES+LTP+VVM
29-Sep-99 Post0188 COLD CHAIN & EUTECTICS & LTP
7-Jan-00 Post0214 VACCINE FREEZING
18-Jan-00 Post0218 T-ZONES & LOW TEMPERATURE PROTECTION
8-Feb-00 Post0226 VACCINE FREEZING
15-Mar-00 Post00231 VACCINE FREEZING
6-Apr-00 Post00239 VACCINE FREEZING
18-Apr-00 Post00243 VACCINE FREEZING
27-Oct-00 Post00293 FREEZE WATCH INDICATORS, EXPIRY DATES & USE
1-Nov-00 Post00295 VACCINE FREEZING
17-Nov-00 Post00299 VACCINE FREEZING CONTINUED
28-Nov-00 Post00301 VACCINE FREEZING: REFERENCES
12-Dec-00 Post00304 VACCINE FREEZING CONTINUED
4-May-01 Post00339 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD?
20-May-01 Post00343 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD?
7-Jun-01 Post00347 FREEZING VACCINES
____________________________________*______________________________________
____________________________________*________________________
The Technet Forum is sponsored by the World Health Organization Department
of Vaccines and Biologicals. It is moderated by Allan Bass and hosted on
the Australian Centre for International and Tropical Health and Nutrition
network. www.acithn.uq.edu.au
___________________________________________________________________________
Post00386 PROTECTION OF MORE COLD SENSITIVE VACCINES 23 October 2001
CONTENTS
1. PROTECTION OF MORE COLD SENSITIVE VACCINES
" Hep B freezes at ?0.5, two degrees above DPT. ....field assessments in
recent years have shown that DPT freezing is a common problem,..."
It has been said before, though some denied it: The ball was dropped...
... years ago.
Bob Davis, UNICEF, rightly suggests that it be picked up!
" Bill Gates will, quite rightly, kick our collective rears if he discovers
that we have been sitting on this problem for years and talking about it
instead of taking corrective measures, which we have yet to do. Our friends
in surveillance will scratch their collective heads if they cannot
reproduce, from GAVI recipient countries, the same satisfying results in
morbidity reduction which they have documented in DCs, simply because GAVI
countries are giving frozen vaccine."
John Lloyd, PATH/CVP, points out" The risk of freezing has been heavily
underlined by the data coming out of the PATH 'out of the cold chain' trial
in progress in Indonesia. As you say, Hep B vaccine supplied by the Vaccine
Fund is at serious risk of freezing in the cold chain."
John goes on to state that "we need to prepare for the 'beyond the cold
chain' & 'freeze-safe' & 'monodose vaccine' era by reviewing the priorities
expressed in the specifications that WHO laid down in the second half of the
last century."
" 21st century priorities are:
1) to avoid freezing vaccines - most 'WHO' equipment places vaccine at the
risk of freezing
2) to minimise energy consumption - so that solar/grid hybrid becomes
economic
3) to maximise portability and robustness - to assure safe distribution and
retrieval for repair work on fridges"
HiB vaccine and almost all new vaccines can be damaged by freezing.
* Action?
Replies to: [[email protected]][email protected][/email] or use your reply button!
___________________________________________________________________________
From: [[email protected]][email protected][/email]
Sent: dimanche, 7. octobre 2001
To: [[email protected]][email protected][/email]
Subject: PROTECTION OF MORE COLD SENSITIVE VACCINES
Umit Kartoglu
WHO/Geneva
Dear Umit and other colleagues,
PROTECTION OF MORE COLD SENSITIVE VACCINES
This note is to get the ball rolling on a discussion that we should all have
started two years ago.
We now have $281 million worth of GAVI provided vaccines delivered or in the
pipeline for eastern and southern Africa. The global total, all regions, is
about $610, and likely to rise when this month's GAVI applications and
resubmissions, totaling 40, pass committee review on the 25th of this
month.
Almost all of these vaccines contain cold sensitive hepatitis B vaccine.
This makes more urgent the question of whether EPI should, on a global
basis, return to the 4 to 8? recommended refrigeration range of the 1980s.
There are several persuasive arguments in favor of such a change:
Hep B freezes at ?0.5, two degrees above DPT. Since field assessments in
recent years have shown that DPT freezing is a common problem, this will be
true, a fortiori, for Hep B. Hep B does not, it appear, work well with the
shake test. This is the information which Smithkline supplied to Philippe
Duclos about their product. If true with other suppliers' products, it
leaves us with no technical means to detect freezing of vials at the point
of use (the Freezewatch measures the ambient, not the vial. Moreover, until
the blue Freezewatch indicators become universal, the old red ones will
produce false negatives for Hep B). The low temperature VVM is at least
years away. Today's VVM was 15 years in the pipeline. We have known for
decades that accurate morning and evening temp recording, when done, tells
us nothing about nighttime temperatures, which are always lower, especially
in plateau areas and in places using top opening Vestfrosts (most of India)
and Electrolux top openers.
Bill Gates will, quite rightly, kick our collective rears if he discovers
that we have been sitting on this problem for years and talking about it
instead of taking corrective measures, which we have yet to do. Our friends
in surveillance will scratch their collective heads if they cannot
reproduce, from GAVI recipient countries, the same satisfying results in
morbidity reduction which they have documented in DCs, simply because GAVI
countries are giving frozen vaccine.
The ideal solution is a low temperature VVM, on which GAVI might want to
spend Window 3 money. I know that industry has to date shown no interest.
Could PATH take this on? By copy, I am asking Suomi Sakai to get this item
put on the next GAVI Board meeting agenda, as a matter of urgency.
In the meantime, we are stuck with no effective monitoring tools for vaccine
vials containing Hep B. Am I correct in believing that the only possible
short term solution to protection of hep B vaccine is to move the
recommended range back up to 4 to 8?? If this were done, would it be a
global recommendation, or should the main polio reservoirs be exempted for a
year or two? Most of these countries are not yet using hep B, since GAVI has
been slow to given Window 2 funding to major reservoirs.
I do not see that we have any justification, other than institutional
conservatism, not to recommend returning to the 4 to 8 standard.
Best Regards,
Bob Davis
---
From: [[email protected]][email protected][/email]
Sent: mercredi, 17. octobre
To: [email=]'[email protected][/email]'; [[email protected]][email protected][/email]; [email=]'[email protected][/email]';
'[email protected]'; [email=]'[email protected][/email]'
Subject: RE: PROTECTION OF MORE COLD SENSITIVE VACCINES
Robert, Umit,
The risk of freezing has been heavily underlined by the data coming out of
the PATH 'out of the cold chain' trial in progress in Indonesia. As you say,
Hep B vaccine supplied by the Vaccine Fund is at serious risk of freezing in
the cold chain.
I am copying your message to Michael Free at PATH who I think will reply
that we have been trying for several years to find a 'VVM-freezewatch'
technology without success to date. The prospects are so poor of finding
this technology that I doubt that Michael will promise much for the
foreseeable future.
Nor will the problem disappear if we return to a storage standard of 4 to 8
C. Icepacks currently melt at freezing point and may spend many hours below
freezing if used fresh from the freezer - around 10% of the liquid vaccine
in a good cold box will be frozen this way. Refrigerators simply cannot be
regulated to stay in that range. Michael will tell you of wondrous new
eutectic and insulation technologies that will solve this problem however,
and we should pursue this route for the future. That is where some R&D money
might be well spent.
Out of the cold chain might seem to be another solution...but the early data
from Indonesia seem to suggest that wholesale removal from the cold chain
will not work for HepB unless air conditioning is provided...which is more
problematic maintenance -wise than refrigerators! Unfortunately, freezing
takes place at most levels of the cold chain, thanks to the Ice Lined
Refrigerator and the thermostat-less kerosene refrigerator. So it is hardly
possible to specify certain levels 'out of the cold chain'and not others.
In the meantime, we need to review the temperature monitoring equipment that
we have been recommending for the last 20 years and see if there are now
better options to recommend for each level of the cold chain. Then we have
to sensitize health workers and storekeepers to the freezing risk,
particularly for Hep B vaccine, and warn them of risky practices.
All the best,
John
---
From: "Lloyd"
To: , , ,
,
Subject: Freeze-safety and WHO equipment performance standards
Date: Thu, 18 Oct 2001
More on this subject (for Allan's Forum why not?):
It occurs to me that we need to prepare for the 'beyond the cold chain' &
'freeze-safe' & 'monodose vaccine' era by reviewing the priorities expressed
in the specifications that WHO laid down in the second half of the last
century.
Current, 21st century priorities are:
1) to avoid freezing vaccines - most 'WHO' equipment places vaccine at the
risk of freezing
2) to minimise energy consumption - so that solar/grid hybrid becomes
economic
3) to maximise portability and robustness - to assure safe distribution and
retrieval for repair work on fridges
These priorities can be met by high efficiency solar/grid hybrid
refrigeration systems and high-temperature eutectics more easily,
efficiently and economically (per litre storage space) than the current
'vaccine-specific' cold chain equipment
It is no longer a priority to:
1) Have a long hold-over time in refrigerators - because vaccines have VVMs
and are quite stable
2) Freeze water icepacks - that put vaccine at risk
3) Have a long cold life for vaccine carriers - because VVMs permit 'beyond
the cold chain'
4) Promote absorption refrigeration where there is little or no
electricity - now that solar/grid hybrid is competitive - and better!
Let us start to re-think our priorities for specifying cold chain equipment,
both refrigerators and vaccine carriers/cold boxes. That way, we can meet
the priorities of the future and lay the priorities of the past to rest.
All the best,
John
---
Subject: Re: Freeze-safety and WHO equipment performance standards
To: [[email protected]][email protected][/email];aylwardb.unicef.org, [[email protected]][email protected][/email], [[email protected]][email protected][/email],
[email protected], [[email protected]][email protected][/email], [[email protected]][email protected][/email], [[email protected]][email protected][/email],
[email protected],
[email protected], [[email protected]][email protected][/email]
From: [[email protected]][email protected][/email]
Date: Fri, 19 Oct 2001
Dear All,
Given the problems of protecting cold sensitive vaccines, one could think
of a WHO/UNICEF recommendation that vaccine refrigerators be set at 8
degrees at noon (or the hottest time of the day) so as not to fall below
zero at night. A notice to this effect could be placed on newly procured
refrigerators supplied through the agencies.
This would require no change in current EPI policy, but would simply be a
way of insuring that the current policy is properly implemented.
Cheers,
Bob Davis
___________________________________________________________________________
These Technet Forum Postings discussed the freezing of freeze sensitive
vaccines and related issues and technologies.
They are available for download. See file download details below.
DATE POST
10-Nov-98 Post0074 LOW TEMPERATURE PROTECTION
27-Jan-99 Post0102 LOW TEMPERATURE PROTECTION
2-Feb-99 Post0104 LTP
16-Feb-99 Post0111 T-ZONES LTP
19-Feb-99 Post0113 T-ZONES AND LTP
25-Feb-99 Post0116 T-ZONES & LTP
26-Feb-99 Post0117 T-ZONES & LTP
12-Mar-99 Post0123 T-ZONES+LTP+VVM
29-Sep-99 Post0188 COLD CHAIN & EUTECTICS & LTP
7-Jan-00 Post0214 VACCINE FREEZING
18-Jan-00 Post0218 T-ZONES & LOW TEMPERATURE PROTECTION
8-Feb-00 Post0226 VACCINE FREEZING
15-Mar-00 Post00231 VACCINE FREEZING
6-Apr-00 Post00239 VACCINE FREEZING
18-Apr-00 Post00243 VACCINE FREEZING
27-Oct-00 Post00293 FREEZE WATCH INDICATORS, EXPIRY DATES & USE
1-Nov-00 Post00295 VACCINE FREEZING
17-Nov-00 Post00299 VACCINE FREEZING CONTINUED
28-Nov-00 Post00301 VACCINE FREEZING: REFERENCES
12-Dec-00 Post00304 VACCINE FREEZING CONTINUED
4-May-01 Post00339 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD?
20-May-01 Post00343 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD?
7-Jun-01 Post00347 FREEZING VACCINES
____________________________________*______________________________________
There are no replies made for this post yet.