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Post00325 VACCINE VIAL MONITORS 1 March 2001
CONTENTS
1. VVM - DRY ICE TROUBLE? NO! MORE!
2. VVM ON VACCINES: CURRENT STATUS AND PLANNED ROLLOUT
1. VVM - DRY ICE TROUBLE? NO! MORE!
In Technet Forum Post00314, VVM - DRY ICE TROUBLE? NO!, 25 January 2001,
Fred Simiyu, WHO Nigeria, reported "Last week I heard it mentioned by a
UNICEF colleague that a recent study indicates dry ice, when used to pack
vaccines with VVMs, causes change in VVM colour simulating exposure to
heat." Fred sent an email to Modibo Dicko, WHO/AFRO, enquiring if VVMs had a
problem with dry ice exposure, and wondering if that would account for VVM
changes observed in a recent oral polio vaccine shipment to one district.
Hans Everts, WHO/EPI, initially responded, pointing out that the heat
exposure may have occurred prior to being packed for shipment.
Alissa Klopper, Lifelines Inc, the VVM company, reports on the testing of 4
production lots from different manufacturers, showing no change on exposure
to dry ice - for as many as 8 days.
Following that posted discussion, Michel Zaffran asked for clarification on
the test procedures and the field situation:
"Were the vials (and therefore the VVMs) in direct contact with the dry ice
during the shipment to Anambra and not during the tests conducted at
Lifelines? Could the color change have been provoked by a direct physical
contact of VVM with dry ice ?
In todays posting Fred Simiyu, WHO Nigeria, kindly details what really
happened in the field. Ted Prusik, Lifelines, kindly clarifies the testing
of VVMs with Dry Ice.
* The answer is that the problem was that heat exposure caused the VVMs to
change - NOT contact with dry ice.
Opinion, comments and suggestions please: [[email protected]][email protected][/email]
or use your reply button
___________________________________________________________________________
From: [[email protected]][email protected][/email]
To: [[email protected]][email protected][/email]
Subject: RE: Post00314 VVM - DRY ICE TROUBLE? NO!
Date: Thu, 25 Jan 2001 08:11:59 +0100
Allan,
Could we ask Alissa Klopper and Fred Simiyu the following question:
Were the vials (and therefore the VVMs) in direct contact with the dry ice
during the shipment to Anambra and not during the tests conducted at
Lifelines? Could the color change have been provoked by a direct physical
contact of VVM with dry ice ?
Michel
---
Date: Fri, 09 Feb 2001
To: [[email protected]][email protected][/email]
From: Fred Simiyu
Subject: RE: Post00314 VVM - DRY ICE TROUBLE? NO!
Dear Allan,
Consultations with colleagues on what really happened with the OPV VVMs
during NIDs in Anambra State in Nigeria indicate that:
1.) The NIDs OPV whose VVMs changed WERE NOT packed with dry ice but with
ice packs, most of which had already melted on arrival in Anambra after
staying on the road for almost 15 hrs. The constraints that led to this
situation have been discussed in Nigeria and proposals made to prevent a
recurrence.
2.) The routine OPV boxes that were supplemented with dry ice arrived with
their VVMs intact. The dry ice, it has been verified, was wrapped up in
papers and was not in direct contact with the VVMs.
3.) Earlier, the question of effect of dry ice on VVMs was raised, given
(a) the quantity of NIDs OPV whose VVMs changed, which was 96% (over 1M
doses) of that shipped for NIDs to Anambra State,
(b) a reference made by a technical officer to some on-going study about
the effect of dry ice on VVMs and
(c) dry ice was used with (some of) the shipment to Anambra.
>From this, it would appear that in the Nigerian experience the dry ice may
not have been the cause of the VVM changes. Especially since the routine OPV
in the same consignment had dry ice and arrived with their VVMs intact.
Possible causes in our case include transit time, exposure at hanger,
previous exposure, increased movement capacity (NIDs + routine) putting a
strain on existing facilities.
The logistics team in Nigeria has already proposed mechanisms to the ICC
technical committee addressing most of the possible causes to avoid future
vaccines over-exposure risks.
Fred
---
Date: Tue, 13 Feb 2001
From: Ted Prusik
Subject: RE: Post00314 VVM - DRY ICE TROUBLE? NO!
To: [[email protected]][email protected][/email]
Dear Allan,
As a follow up to the previous posting on this subject and to clarify
exactly how the VVM samples were located relative to the dry ice, please be
advised that the procedure used to test the VVMs was conducted as follows:
VVMs were placed directly in an Igloo cooler with dry ice for the first two
days. The VVMs were not sealed in any pouches, simply physically in the
cooler with dry ice. After two days, the ODs (color) of the samples were
measured with a reflectance densitometer and the samples were then placed in
a dry ice storage container with a block of dry ice below the VVMs and a
block of dry ice above the VVMs for the next 3.8 days, again with no
protective packaging. Color of the VVMs was again measured. Therefore,
there was both indirect exposure to dry ice and direct contact of the VVMs
with dry ice during the test period. As reported previously, there was no
measurable difference in the OD of the stored samples.
If there is any other information needed, please feel free to contact me.
Kind Regards,
Ted Prusik
____________________________________*______________________________________
2. VVM ON VACCINES: CURRENT STATUS AND PLANNED ROLLOUT
Dianne Philips, SA/DOH, asks about the status of VVMs on all EPI vaccines.
Chris Caulfield, Lifelines, Kindly replies with this working document
listing the vaccines, manufacturers, country, and type of VVM - as of
January 1, 2000 - December 31, 2000. The expected rollout of VVMs on other
vaccines in 2001 is also listed.
* The use of VVMs is clearly set to expand beyond their use on OPV now.
Countries programs will need to expand training and quality assurance
measures. We will need to monitor and evaluate the effect on vaccine
utilization and vaccine wastage.
Opinion, comments and suggestions please: [[email protected]][email protected][/email]
or use your reply button
___________________________________________________________________________
Date: Mon, 29 Jan 2001
From: "Dianne Phillips"
To: [[email protected]][email protected][/email]
Subject: VVMs
Hi Allan,
I am trying to find out the status of VVMs on all vaccines in the EPI
programme. We are due to go out on tender in a few months, and I am unable
to ascertain whether WHO/UNICEF vaccines all have VVMs attached to the
labels.
Can someone please assist with the relevant information
Many Thanks
Dianne Phillips Tel: +2712 3120329
National Cold Chain Manager Fax: +2712 3244525
Department of Health Mobile: +2782 8069253
Private Bag X828
PRETORIA
South Africa
0001
---
Date: Tue, 20 Feb 2001 11:15:04 -0500
From: Chris Caulfield
Subject: re: VVM labeling update
To: [[email protected]][email protected][/email]
Dear Allan,
Please find a document that I recently produced for Dr. Julie Milstien at
WHO. This document shows the Manufacturer, Country, Vaccine Type, VVM Type
and Status. The first page are all current VVM customers.
This is a working document. As the UNICEF tender and the Bill & Melinda
Gates Children's Vaccine Fund tender are awarded, I believe that the list
will grow.
If you require any additional information, please contact me.
Best regards,
Chris Caulfield
Marketing & Sales Manager
LifeLines Technology, Inc.
___________________________________________________________________________
Moderators Note: Formatting will vary depending on your email reader
settings. ASCII or ANSI plain text is the best setting to view this
document.
___________________________________________________________________________
LifeLines Technology, Inc.
116 American Rd
Morris Plains, NJ 07950
Main: (973) 984-6000
Fax: (973) 984-1520
Email: [[email protected]][email protected][/email]
Vaccine Vial Monitor Customers
January 1, 2000 - December 31, 2000
Vaccine and Customer
Current Customers
Vaccine Customer Country Type of VVM
OPV
Aventis - Pasteur (Belgium) D
BIBCOL (India) D
Bio Farma (Indonesia) D
Bio - Med (India) D
Chiron (Italy) D
Haffkine (India) D
Panacea (India) D
SmithKline Beecham (France) D
Vacsera (Egypt) D
Measles
Chiron (Italy) B
BCG
Japan BCG (Japan) A
Hepatitis B
LG Chemical (Korea) A
UNIJECT (TT & HBV)
Bio Farma (Indonesia) A
___________________________________________________________________________
Pending Future Customers - 2001
TYPE A
Bio Farma (Indonesia) DT A
Order in Process
DTP A
Order in Process
TT A
Order in Process
Green Cross Vaccine Corp. (Korea) HBV A
Information Requested
Human (Hungary) DPT A
Samples submitted
DT A
Samples submitted
TT A
Samples submitted
NCIPD (Bulgaria) BCG A
Samples submitted
SII (India) DPT A
Samples submitted
DT A
Samples submitted
TT A
Samples submitted
TYPE B
Pasteur Dakar (Senegal) Yellow Fever B
Order in Process
SII (India) Measles B
Samples submitted
SSI (Denmark) BCG B
Samples submitted
TYPE C
Aventis-Pasteur (Belgium) DPT C
Samples validated
Bio Farma (Indonesia) Measles C
Artwork Received
Chiron (Italy) Moruvar C
Order received
Cheil Jedang (Korea) DPT C
Order received
TYPE D
Bo-Ryung Pharma (Korea) OPV D
Shipment Sent
Green Cross Vaccine Corp. (Korea) OPV D
Shipment Sent
Razi Institute (Iran) OPV D
Samples submitted
TO BE DETERMINED
SKB (Belgium) DTP-HBV TBD
Pending
DTP-HBV-HIB TBD
Pending
MUM TBD
Pending
____________________________________*________________________
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