Title: Multi-dose open vial policy
Course: Immunization - Ethiopia (Full)

Multi-dose open vial policy

WHO Policy Statement, 2000, The use of opened multi-dose vials of vaccine in subsequent immunization sessions.

In order to reduce vaccine wastage, the Ethiopian Federal Ministry of Health (FMOH) and the World Health Organization (WHO, 2000) have developed guidelines on how to continue using vials of some types of vaccines once they have been opened, so they are not discarded unnecessarily at the end of the immunization session. These vaccines are supplied in multi-dose vials containing preservatives, so each vial can be used for many doses. Opened vials that are returned to the refrigerator must be labelled with the date they were opened, so you know when to discard them.

Opened vials of OPV and TT vaccines are the only EPI vaccines used in Ethiopia that can be used in subsequent immunization sessions within four weeks until the vaccines in the vials are fully used, provided that all five conditions in Box 7.1 are maintained. These conditions must be observed at every immunization session at the Health Post or at an outreach site.

Box 7.1  Conditions for using opened vials of multi-dose vaccines

Expiry dates are written in the European calendar (not the Ethiopian calendar).

- The expiry date has not been passed, i.e. the date after which the vaccine should not be used for immunization.
- The vaccines have been stored between +2^oC and +8^oC under appropriate cold chain conditions at all times.
- The vaccine vial has not been submerged in water (e.g. from leaking ice-packs in a vaccine carrier).
- The vaccine vial monitor (VVM), if attached, has not reached its discard point (look back at Figure 6.8 in Study Session 6).
- A new sterile needle and syringe and standard infection-control procedures have been followed to prevent contamination of vials when vaccine doses were withdrawn previously.

Standard procedures to reduce the risk of infection, contamination and injuries were taught in Study Session 4.

Source: Adapted from WHO, 2004, Immunization in Practice, Module 3, The Cold Chain, p.16

Why do you think it is important to prevent opened vials from being submerged in water?

Show answer

The rubber membrane protecting the top of an opened vial has been pierced by needles whenever previous doses were withdrawn, so water could get into the vial if it becomes submerged.

If the conditions in Box 7.1 have been maintained, opened vials of OPV and TT vaccines may be returned to your refrigerator at a temperature between +2^oC and +8^oC after an immunization session. Put them in the ‘use first’ box to remind you that they should be used first (before unopened vials) the next time you give immunizations with these vaccines. (Look back at Figure 6.12 and note the position of the ‘use first’ box in the front-loaded refrigerator.)

Vaccines that should not be returned to the refrigerator after an immunization session are:

- opened vials of reconstituted BCG and measles vaccines
- opened vials of PCV10 vaccine (which does not contain a preservative).

These vaccines must be discarded 6 hours after reconstitution, or at the end of each immunization session — whichever comes first.

If a PCV10 vial is opened for one child and another is not immediately available to be vaccinated with the remaining dose in the two-dose vial, you should:

- write the time that the vial was opened on the vial so you can discard it after 6 hours if it has not been used
- ensure that the vial is kept cool in the foam pad of the vaccine carrier
- ensure that the vial is kept away from potential contamination.

Any unopened vials of vaccine – including unopened pentavalent vaccine, which is supplied in single-dose vials – can be returned to the refrigerator at the end of an immunization session, providing that the expiry date has not passed, storage under cold chain conditions has been maintained at all times, and the VVM has not reached the discard point.

However, if the VVM indicates that the vaccine has reached its discard point, then it should of course be thrown away and not used. Any vaccine which has passed its expiry date should also be discarded. You will learn how to do this safely later in this study session.