Post00343 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD?

Post00343 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD? 20 May 2001 CONTENTS 1. WHY IS THE COLD CHAIN TOO COLD? MORE..... 2. HEP-B OUT OF THE COLD CHAIN? 3. VVMs ON VACCINES 1. WHY IS THE COLD CHAIN TOO COLD? MORE..... The freezing point of Hepatitis B vaccine is -0.5'C The findings of a multi year-multi site study, including a clear description of the failure modes leading to frequent long duration freezing events in refrigerators used for vaccine storage, were reported in Post00339, 4 May 2001, by Soren Spanner, WHO/SEARO, who kindly posted the file of his recent presentation. The evidence is unequivocal in demonstrating that all freeze sensitive vaccine stored in the cold chain is at risk of damage. "The big investment and little effectiveness is exactly my point" to quote from Soren's email of April 13, 2001. Clearly without operational and vaccine management changes - a long term developmental process, this damage to vaccines will continue. In todays posting, Andy Tucker, PATH-CVP, Anthony Battersby, FBA Analysts, Hans Everts, WHO/EPI, and Soren Spanner, WHO/SEARO discuss the field situation and technical developments. Opinion, comments and additions please: [log in to unmask] or use your reply button ___________________________________________________________________________ Get the file on the web at: ftp://ftp.acithn.uq.edu.au/Technet/1-ClickHereForTECHNETfiles/VAX-Freeze/ Click on the file: WHY IS THE COLD CHAIN TOO COLD.pdf This file is large at 1.8 Mb. It is too large to make available for email download - as most email systems will bounce the file. If you are unable to download the file on the web but still would like it please let us know - we will see if there is another way to get you the file. ___________________________________________________________________________ From: "Andy Tucker" To: "Technet Moderator" Subject: Re: Post00339 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD? Date: Sun, 13 May 2001 Hi Allan, Glad to see this issue being raised. It is of critical importance in Cambodia. We are assisting the NIP to introduce DTP-hepB vaccine into the EPI later this year. I'll share some experience here. Recently, the NIP manager of the cold chain used a data logger to track temperatures during vaccine delivery. The data showed that the delivery from central storage to province using cold boxes and ice packs kept the vaccine at temperatures consistently below -1C (during about 19 hours) and went as low as -1.8C for 3+ hours. The delivery from district to health centre (and stored there) in a vaccine carrier with ice packs kept the temperature consistently near 0C (even dipping to -0.03C for 3+ hours) for nearly a day (the data logger ran out of memory after that). A check of the freezer at central level showed the freezer working well and the temperatures in the past few days to be consistently varying between 0C and 2C. We had a short discussion about the need to have it vary between 2C and 4C, especially once the new vaccine is delivered, and will be following up on that. With the freezing point of hepB vaccine at -0.5C, we will need to find a solution for transport....and even storage as districts (and some health centres) currently use cold boxes to store vaccine. One wonders if there has been any problems with DTP as the cold box temperature in the experiment approached the freezing point of -2C (according to the NIP manager here)!? I have three questions (well, and a few follow-ups of course) for the group: Will VVMs be developed for DTP-hepB vaccine? One is more heat sensitive; the other, more cold sensitive. Are the specifications changed in combination? When can we expect the VVMs to be available? There will be a huge demand given the global increase in hepB vaccine use. Also, the NIP here continues (more than a year at least) to ask when VVMs will be available for measles vaccine (People hear rumours that it exists.) Why would the wait for hepB be any shorter? What are the thoughts about transporting the vaccine outside the cold boxes as a possible (interim) solution? Transport usually takes 1 day or less, though that is occasionally extended to 2-3 days if problems occur. This still might not solve the issue of STORING the vaccines in cold boxes. I apologize if any of this is covered in Soren's presentation; I, too, am having difficulty downloading off the web but will persevere. Regards, AwT Andy Tucker, MPH Program Associate Cambodia Office, Mekong Region Bill and Melinda Gates Children's Vaccine Program at PATH Tel/Fax: (855 23) 215 005 Mobile: (855 16) 889 349 E-mail: [log in to unmask] http://www.ChildrensVaccine.org [Moderators Note: See Item 3. VVMs ON VACCINES below for the answer to Andy's question on VVMs on vaccines] --- Date: Fri, 4 May 2001 From: Anthony Battersby Subject: Post00339 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD? To: Technet Moderator Dear Allan, A small comment, I have just come across the Vestfrost MK74 with the new thermostat, for the first time here in PNG. As you know it has 2 thermostats, one controlled from outside the cabinet and one controlled from inside both are numbered 1 to 7. The higher the number on the outside one the colder it gets, the higher the number on the inside one the warmer it gets. The folks here trying to understand this equipment are getting very confused, why oh why could Vestfrost not make both thermostats work in the same way, higher the number the colder the setting. What I have been finding is that the refrigerators are far to warm because the staff keep turning up the internal thermostat to try and drop the temperature. Has this problem been experienced elsewhere? Cheers Anthony Goroka PNG --- From: [log in to unmask] To: [log in to unmask] Subject: RE: Post00339 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD? Date: Mon, 14 May 2001 In post00299 I have explained what changes we have required from manufacturers to prevent freezing in refrigerators and what the limitations of these requirements are as long as we test on basis of an optimum instead of worst case scenario. We need worst case scenario test procedures (Soren?) and/or a solution for the fact that the thermostat setting during the tests is not necessarily the one chosen by the health worker in the field. I would be interested to know: 1) whether the problem of freezing still occurs in appliances recently received in the countries. The solutions implemented by manufacturers consisted of changing the position of the probe, installing a rack that prevents storage against the evaporator, etc. 2) is the temperature zone clearly marked on recently received appliances? It should be on the lid or the front door, clearly visible. Regards Hans Everts WHO Geneva Technical officer EPI +41 22 791 3683 [log in to unmask] --- From: "Spanner, Mr. Soren" To: "Technet Moderator" Subject: RE: Post00339 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD? Date: Tue, 15 May 2001 Dear Hans and Allan, I'm afraid that we are getting things mixed up now! The ILR with 2 thermostats is the MK 074, in fact it has 3 thermostats. One evaporator thermostat, one ice-lining thermostat and one thermostat controlling a heating element. This is the type of ILR Anthony was talking about in PNG. The heating element is supposed to ensure that the vaccine compartment is not getting too cold. And that thermostat applies more heat the higher the no., the thermostat controlling the compressor is applying more cold the higher the no. Finally, the ice-lining thermostat is not adjustable. I don't think that it is the fact that the thermostat is operating reverse that confuse the users. I think that it is the whole concept of an ILR producing heat!! As for the new MK 144,204,304 with an electronic thermostat, they are much better than what we have seen previously, however, it is still possible with wrong thermostat setting to achieve negative temperatures. That is why we need new test procedures! I have not seen any temperature zone marking as yet, but I have not received equipment since stickers were introduced. I can tell you that Delhi is 40+C best regards Soren --- From: [log in to unmask] To: [log in to unmask], "Technet Moderator" Subject: RE: Post00339 VACCINE FREEZING: WHY IS THE COLD CHAIN TOO COLD? Date: Tue, 15 May 2001 Thanks Soren. Good to hear Vestfrost improved. I would appreciate that this is mentioned to Technet members, just to deal with the persisting rumours that nothing has happened. All other manufacturers were supposed to make similar improvements and mostly did so. It is now up to the field to give us the feedback. Agreed, the next thing is to deal with the test procedures. I will check the use of the T zone stickers with UNICEF and the manufacturers. Can you give me some information about when you received appliances without sticker? This applies of course to all readers of the Technet forum. The temperature zone should now be clearly marked on all appliances received recently in the countries. Regards Hans Everts WHO Geneva Technical officer EPI +41 22 791 3683 [log in to unmask] ____________________________________*______________________________________ 2. HEP-B OUT OF THE COLD CHAIN? John Lloyd, PATH-CVP adds to the discussion of the proposal to move Hepatitis B vaccine out of the cold chain from district level down to service delivery level as proposed in Technet Post00339, 4 May 2001. John notes that Hep B vaccine out of the cold chain in Uniject may have a cost advantage - as well as enhanced injection safety inherent in the use of the Uniject prefilled pouch and needle device. Opinion, comments and additions please: [log in to unmask] or use your reply button ___________________________________________________________________________ It is proposed that Technet recommend: 1. Make countries' central level storage and distribution freeze sensitive vaccine safe by: - equipment modification - Change operator behavior through training and supervision 2. Implement VVMs on HepB vaccine and use VVMs to manage the vaccine out of the cold chain from district level down to point of use. ___________________________________________________________________________ From: "John Lloyd" To: "Allan Bass" Subject: RE: Paper on priorities for development of immunization technologies Date: Fri, 27 Apr 2001 We are extremely keen to take Hep B out of the cold chain and the district level is where the main cost is....so introducing mono dose vaccine in UniJect will be less expensive if we can take the vaccine out of the cold chain. Interestingly, we have just shown in Indonesia that the cost of bundling 5 dose vaccine vials with AD syringes is more expensive than implementing UniJect - if UniJect were to be filled with tetravalent vaccine. Even with monovalent Hep B the cost premium of UniJect is very small but this story is in the context of Indonesia where we have shown no extra cold chain is needed, so elsewhere, cold chain at district level could be a big issue. Yours, John ____________________________________*______________________________________ 3. VVMs ON VACCINES This list of manufacturers with vaccines scheduled to have VVM labeling was posted to Technet Forum in Post00325, 1 March 2001. The Moderator understands that UNICEF has extended the deadline for manufacturers to supply all vaccines to UNICEF with VVMs by the end of 2001. * Clarification would be helpful! Opinion, comments and additions please: [log in to unmask] or use your reply button ___________________________________________________________________________ Date: Tue, 20 Feb 2001 From: Chris Caulfield Subject: re: VVM labeling update To: [log in to unmask] 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: [log in to unmask] 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 ____________________________________*______________________________________