3rd Global Meeting on Implementing New and Under-utilized Vaccines, 16-18 June 2009
Workgroup 3. Looking at visual cues and choosing preferred vaccine presentations
The current Multi-Dose Vial Policy (MDVP) states that under certain conditions, opened multi-dose vials of OPV, DTP, TT, DT, hepatitis B, and Hib liquid vaccines can be kept for 28 days, and that other, specified vaccines (measles, BCG) must be discarded at the end of the immunization session, or after six hours. Practically, this translated in the field into the simple rule currently used by health workers: “liquid: keep; lyophilised: discard”. However, this rule will no longer work with new vaccines such as two-dose vials in liquid formulation that do not contain preservative (PCV10 and HPV vaccines) and the lyophilised Meningococcal A vaccine that does come with preservative and could be kept for subsequent sessions. Therefore, a new ‘visual cue’ is needed to enable a vaccinator to tell whether opened vials can be kept for a subsequent session or discarded just by looking at the vial.
The ‘visual cue’ is one aspect of a broader topic: optimal packaging and presentation for vaccines used by the public sector in developing countries. Several visual cue options are currently being reviewed by the Technologies and Logistics Advisory Committee (TLAC). The Vaccine Presentation and Packaging Advisory Group (VPPAG) has developed a draft paper on the broader packaging and presentation discussion to help guide industry and vaccine developers.
Main Topics of Discussion
- Adequate training and job aids are required for any option.
- All WHO prequalified vials need to be clearly marked with some kind of labelling or logo.
- The default position is always to discard (so an un-marked vial would need to be thrown away).
- Visual cues need to be "gripping".
- Vaccine manufacturers need to be in agreement with these issues.
- The interim transition needs to be well understood.
- Visual cues to be developed that enable health workers to use preservative-free multi-dose vials safely and appropriately without unnecessarily increasing vaccine wastage rates.
- Interested parties (e.g. field staff, vaccine industry) will have the opportunity to review the concept paper on visual cue options currently being reviewed,, which then should be completed and presented to the Technology Logistics and Advisory Committee (TLAC) for their endorsement.
- The VPPAG paper on Generic Preferred Product Profile for Vaccines should be reviewed and finalized by September 2009 and disseminated widely.