Post00325 : VACCINE VIAL MONITORS

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 ____________________________________*________________________