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)".
____________________________________*______________________________________
____________________________________*______________________________________
There are no replies made for this post yet.