New Vaccine Post-Introduction Evaluation (PIE) Tool
Appendix 6: Common problems and solutions
Table 11 below lists some of the more commonly encountered problems relating to new vaccine
introduction, and some general EPI problems. The circumstances leading to these situations may differ
from one location to another and between countries. While the recommended steps are not exhaustive,
they should serve as a starting point for corrective action, and may be useful in formulating
recommendations following the fieldwork.
Table 11
Common problems encountered in an EPI programme when introducing a new vaccine and
suggested solutions
Scenario
Vaccine coverage is >100%
Suggested solutions
 Frequently, the denominator population is incorrect. Investigate the
denominator problem; this could be influenced by campaigns or
outdated population statistics.
Immunization coverage for new vaccine is
lower than rate for old comparable vaccine.
 Look at data accuracy:
- If the number of doses delivered (numerator) is higher or lower
than estimated, immunization coverage estimates will be either too low
or too high.
- If the target population (denominator) is over- or underestimated,
vaccine coverage estimates will be either too low or too high.
 Encourage routine review and analysis of coverage data during
supervisory visits.
 Determine if there are any problems with community acceptance of the
new vaccine.
 Determine if the lower coverage is due to supply issues.
Note: Immunization coverage post
introduction should be similar to that of other
comparable vaccines. Vaccines that require
an additional injection may have a lower rate
of uptake in the first months because of
requirement for additional injection.
Combination vaccines may have higher
uptake since no additional injection is
required and there is increased awareness of
the vaccine.
Vaccines stored at inappropriate temperature
(too hot or too cold).
Note: Vaccine freezing is one of the most
common pitfalls faced by an immunization
programme; many vaccines lose potency if
frozen.
 If refrigerator is not working well, it should be repaired or replaced.
 Verify that refrigerator temperature is monitored twice a day (including
weekends).
 Ensure that staff are trained in basics of vaccine storage and refrigerator
maintenance through supportive supervision or stock management.
 Freeze-watch monitors should be considered for all refrigerators and
during transportation.
 Thermostat should maintain refrigerator temperature between +2° and
+8° Celsius. Tape thermostat in position to avoid accidental movement.
 A backup power supply or plan should be available for when the
primary source of power is lost (e.g. a generator or extra kerosene).
 Posters with temperature guidelines should be placed on all
refrigerators.
 Staff should know how to conduct the shake test to determine if vaccine
has been frozen.
 Staff should know how to read vaccine vial monitors (these are heatsensitive indicators printed directly onto vial labels).
 During transportation and immunization sessions the vaccine must not
be in direct contact with frozen ice packs.
 For short distance travel, vaccine should be packed with conditioned
frozen ice packs (frozen ice pack kept at room temperature for 15–45
minutes until you can hear water when shaken).
 Recommend additional training as needed.
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New Vaccine Post-Introduction Evaluation (PIE) Tool
Over- or under-stock of vaccine or vaccine
supplies.
Note: Additional resources are available from
WHO Vaccine Stock Management Guidelines
(WHO/IVB/06.12)
http://www.who.int/vaccinesdocuments/DocsPDF06/826.pdf.
Health-care worker knowledge attitude and
practice gaps identified.
Note: This includes issues such as insufficient
knowledge, unsafe vaccine practice, and
incorrect administration of vaccine.
 Determine reasons for over- or under-stock, e.g. transportation/delivery
delays.
 Recommend that supportive supervisory visits include observation of
stock management activities.
 Recommend use of a stock report form.
 Ensure that staff know how to calculate minimum and maximum stock
levels (see section 2.4). Minimum and maximum stock level should be
established if none exists.
 Revise ordering practices to ensure vaccines are bundled.
 Conduct periodic refresher EPI courses for workers at all levels.
 Increase supportive supervision with written recommendations and
follow-up checks.
 Use supervisory visits to conduct on-the-spot training.
 Update reference manuals to be available on site.
 Use training for new vaccine introduction to address/refresh other
general EPI training needs.
Insufficient supervision at health facility and
province/district.
 Recommend regular supportive supervisory visits to the health facility
with written recommendations and follow-up checks.
 Recommend additional supervisory visits to health facility when a new
vaccine is introduced.
 Recommend at least bi-monthly supervisory visits at the
provincial/district level.
 Recommend use of supervisory checklists that contain topics
specifically related to the introduction of the new vaccine.
Waste accumulating without appropriate
disposal.
 Recommend a point person for vaccine waste management at
provincial, district and health-facility level.
 Have a clear waste-management plan that is shared with all
immunization workers.
 Recommend training on hazardous waste material disposal.
 Provide onsite incinerators where appropriate.
Vaccine wastage exceeds recommended rate.
 Where applicable, WHO's policy on multi-dose vials1 should be used
for multi-dose vials.
 If wastage occurs due to vaccine expiration or improper handling,
provide recommendations to improve cold chain and vaccine
management as outlined above.
1
Multi-Dose Open Vial Policy states that certain vaccines (mostly liquid) can be stored for up to four weeks and reused
pending certain conditions, such as expiration date, appropriate storage temperature and antiseptic techniques. However, for
BCG, measles, yellow fever, and some formulations of Hib vaccines, once reconstituted, they must be discarded at the end of
each immunization session or at the end of six hours, whichever comes first (http://www.who.int/vaccines-
documents/DocsPDF99/www9924.pdf).
2