Thursday, 14 June 2001
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Post00350 VVM NOMENCLATURE 14 June 2001 CONTENTS 1. CHANGING VVM NOMENCLATURE Umit Kartoglu, WHO/V&B/ATT, kindly posts this clarification of VVM nomenclature, in response to a previous posting asking what A,B C and D referred to in the VVM world. The message below is a reflection of the action being taken to clarify the confusion of having two ABCD heat exposure indicators used in the vaccine cold chain. Extracts: 'There is some confusion between the class of shipping as described in "Guidelines on the International Packaging and Shipping of Vaccines" (EPI/CCIS/81.4 Rev 6) and the Type of VVM since they both utilize ABC nomenclature. Based on the consultations with Lifelines, PATH, WHO and UNICEF, it was agreed to change the VVM nomenclature. Now, we are in the process of renaming the VVM types based on the number of days to reach to end point at +37'C (which is the required minimum days for stability of vaccines). In this case, VVMs would be renamed as VVM2, VVM7, VVM14 and VVM30. Changing the VVM nomenclature will only take effect after issuance of the revised version of the "Specifications for VVMs (E6/IN5)".' * Opinion, comments and additions please: [log in to unmask] or use your reply button ___________________________________________________________________________ From: [log in to unmask] To: [log in to unmask] Cc: [log in to unmask] Subject: RE: Post00347 FREEZING VACCINES Date: Tue, 12 Jun 2001 12:26:13 +0200 Hi Allan, I would appreciate if you could post the following message on VVM specifications. Thanks and cheers, UMIT regards, Umit Dr. Umit Kartoglu Technical Officer V&B/ATT, HTP Room M230 World Health Organization Avenue Appia 20, CH-1211 Geneva 27 Switzerland Tel: +41 22 791 4972; Fax: +41 22 791 4384 Mobile: +41 79 475 5467 e-mail: [log in to unmask] ___________________________________________________________________________ CHANGING VVM NOMENCLATURE VVM specifications are explained in E6/IN5 document published by the WHO on 13 August 1999. These specifications apply to test procedures of E6/PROC/5. Lifelines Technology Inc., (LTI) follows these specifications for all its customers. "Specifications for VVMs (E6/IN5)" defines four different types of VVMs with different reaction rates by category of heat stability: A: HIGH STABILITY VACCINES No. days to end point at +37'C = 30 No. days to end point at +25'C = 193 No. days to end point at +8'C = More than 18 months B: MEDIUM STABILITY VACCINES No. days to end point at +37'C = 14 No. days to end point at +25'C = 90 No. days to end point at +8'C = More than 18 months C: MODERATE STABILITY VACCINES No. days to end point at +37'C = 7 No. days to end point at +25'C = 45 No. days to end point at +8'C = More than 18 months D: LEAST STABLE VACCINES No. days to end point at +37'C = 2 No. days to end point at +25'C = Na* No. days to end point at +8'C = 140 *VVM (Arrhenius) reaction rates determined at two temperature points There is some confusion between the class of shipping as described in "Guidelines on the International Packaging and Shipping of Vaccines" (EPI/CCIS/81.4 Rev 6) and the Type of VVM since they both utilize ABC nomenclature. Shipping guidelines classifies three different types of packaging for different categories of vaccines. The classification has been referred as "vaccine classification" by some manufacturers and resulted in request of wrong type of VVM. For example, in shipping guidelines HepB is classified as class C, but in VVM type it corresponds to type A VVM (VVM30). However, no product has been shipped without WHO approval for the requested VVM type. Although WHO approval of the requested type VVM is a condition for Lifelines to start any production, this misunderstanding caused unnecessary delays up to date. Recently WHO reviewed all available stability data and gave recommendations on approved type of VVM to Lifelines, UNICEF Supply Division and involved vaccine manufacturers even there was no specific request placed. However, there is still a great need to clarify the situation and avoid any misunderstanding to prevent further delays. Based on the consultations with Lifelines, PATH, WHO and UNICEF, it was agreed to change the VVM nomenclature. Now, we are in the process of renaming the VVM types based on the number of days to reach to end point at +37'C (which is the required minimum days for stability of vaccines). In this case, VVMs would be renamed as VVM2, VVM7, VVM14 and VVM30. This would also keep the door open for new types of VVMs based on their prolonged stability data (not a must, but just a possibility). This will also prevent confusion that may cause by the recall factor of matching the "ABC" with "number of days to reach to end point at +37'C. Changing the VVM nomenclature will only take effect after issuance of the revised version of the "Specifications for VVMs (E6/IN5)". ____________________________________*______________________________________ ____________________________________*______________________________________
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