Information Note for Health Workers Application of WHO Multi-dose Vial Policy for Inactivated Poliomyelitis Vaccine (IPV) and Use of Vaccine Vial Monitors (VVMs) In response to new data, the World Health Organization has instituted a policy change for multi-dose vials of the inactivated polio vaccine (IPV), which currently must be discarded at the end of the immunization session, or within 6 hours after opening, whichever comes first. The new policy allows health workers to use multi-dose presentations of IPV (5 and 10-dose vials) for up to 28 days after opening, provided the vaccine is appropriately handled and stored, in accordance with WHO’s policy on handling of opened multi-dose vaccine vials (WHO/IVB/14.07). Current placement of VVMs on IPV vials A VVM can be found on all IPV vials supplied to national immunization programmes and procured through UNICEF. Currently, IPV vials have a VVM on the flip-off cap, to serve as a visual trigger that opened multi-dose vials of IPV must be discarded at the end of the immunization session, or within 6 hours after opening, whichever comes first. Once the vial is opened, the VVM is no longer attached to the vial and therefore can no longer indicate the vaccine vial’s cumulative exposure to heat. Future placement of VVMs on IPV vials Manufacturers are now working to move the VVM from the flip-off cap to the label of the vaccine vial, to better serve as a visual trigger for the multi-dose vial policy. If the IPV vial is opened and kept for subsequent immunization sessions for up to 28 days, the VVM on the vaccine label can continue to indicate the vaccine vial’s cumulative exposure to heat. IPV vials with the VVM on the label are expected to arrive in [country] from [insert date]. What does this mean in practice for you? When the VVM is located on the flip-off cap, opened IPV vials should be discarded at the end of the immunization session, or within 6 hours after opening, whichever comes first. Once IPV vials with the VVM on the label arrive, from [insert date here], the opened multidose vials can be kept and used in subsequent immunization sessions for up to 28 days after opening provided that the following conditions are met: The expiration date has not passed The vaccine continues to be appropriately handled and stored at recommended temperatures (between +2°C to +8°C) The vaccine has not been damaged by freezing The VVM is visible and not past its discard point (see next page) Reading the Vaccine Vial Monitor (VVM) Remember… Vaccine vial monitors (VVMs) show whether a vaccine has been damaged from exposure to heat. If the inside square is lighter than the outside circle, the vaccine is safe to use. If the inside square is the same or darker than the outside circle, then the vaccine must be discarded. VVMs are quick and easy to interpret: Now that IPV has been approved for use up to 28 days after opening, the VVMs will be placed on the vial label, instead of the cap. This allows the VVM to continue monitoring heat exposure after the vial has been opened. IPV – current stock: VVM on CAP 6 hour discard Opened multi-dose vials with the VVM on the cap should be discarded at the end of the immunization session or within 6 hours after opening, whichever comes first. IPV – available after [insert date] 2015: VVM on LABEL 28 day discard Opened IPV multi-dose vials can be kept and used for up to 28 days after opening, provided the expiry date has not passed, the vaccine is appropriately handled and stored, and the VVM indicates that vial can be used. Remember: opened vials should be used first before opening additional vials.
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