Tuesday, 15 April 2003
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POST 00558E : COLOR OF VVMs 15 April 2003 ________________________________________________ mit Kartoglu (mailto:[log in to unmask]) from WHO reports problems with the interpretation of VVM colors and announces a new WHO publication on VVM (link below). Two attachments illustrate correct VVM colors and interpretation. ________________________________________________ SNOW WHITE AND VACCINE VIAL MONITORS Recently, there has been an increased number of complaints regarding the square color of the vaccine vial monitors (VVM). Some complaints came from stores where VVMs attached to locally produced OPV were reported to have been exposed to heat. In one incident, two international OPV shipments were claimed to have 2nd stage VVMs. During the investigation of the latter case, we have found out that two other countries that received the same lot also noted that the VVM on arrival was at stage two. Interestingly in almost all cases, staff was referring to VVM square as "not white". We would like to take this opportunity to underline once again how to read a VVM. WHO confirms that the starting color of the VVM square is NEVER snow white even when stored at minus 20oC or below. The color of the VVM square may have a blue tint which should never be confused with or taken as a beginning of stage 2. Although in many documents and manufacturers' product inserts 4 stages are described in VVM appearance, VVM in principle should not be read in stages. It is important to know that a VVM never jumps from Stage 1 to Stage 2, this transition (darkening of the VVM square) occurs over a period of time depending on the temperature it is exposed. The decision to receive or use the vaccine should be based on the lightness of the VVM square with reference to the outer circle. VVM also comes in slight different hues from batch to batch (bluish to bluish gray). However, the interpretation of the VVM remains the same regardless of slight changes in hue. We would like to confirm that in none of the cases VVM was found to be faulty. The issue was always the wrong interpretation of VVM. In one case the country wanted to reject the two shipments claiming that the VVM was at stage 2. WHO has asked the country to send back claimed samples. In the meantime, WHO also asked the vaccine manufacturer to send the retained vials sample, and the VVM manufacturer to send the retained labels sample. The examination of the VVM color from three sources representing three different stages showed that all VVM squares were the same color/hue. VVM reading in all samples corresponded to the start point. This means that VVMs were NOT exposed to any heat since they were manufactured. On the other hand, it is true that the starting color of the VVM square had been printed as white in WHO training materials. For more than a year now, all documents/reports showing VVM have been printed with the correct light shade of blue/grey. This was also reinforced in a meeting held with vaccine manufacturers in Delhi in January this year. Electronic files including correct VVM illustrations were distributed to all local vaccine manufacturers. We would also like to announce the publication of a new WHO document "Getting started with vaccine vial monitors (WHO/V&B/02.35)" which replaced the old document "Vaccine vial monitors and open-vial policy: Questions and answers WHO/EPI/LHIS/96.01)". The new document can easily be accessed and downloaded from the following URL: http://www.who.int/vaccines-documents/DocsPDF02/www716.pdf With this message we are also attaching two WORD documents (small in size) to assist countries, programmes, all organizations and partner agencies as well as vaccine manufacturers who wish to include VVM illustrations in their publications, documents, reports and/or product inserts. The first attached document taken from the above mentioned WHO publication is an illustration of how to read a VVM. We strongly urge all involved parties NOT to redraw VVM as a grey circle and a white square in the middle, and only use the illustrations that WHO provides. The second document shows a VVM with NO heat exposure (this image is purposely done in black and white for printing purposes). We should also draw the attention to the fact that training materials are often photocopied resulting in the disappearance of slight differences in shades of colors. Even if the original illustration had the correct color, the photocopies will show the square as pure white. "Snow-White" is not a feature of the VVM square. It is only in stories... "Once upon a time, there lived a beautiful princess named Snow White..." ___________________________________________ ______________________________________________________________________________ Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:[log in to unmask] Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. 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