1. World Health Organization
10 April, 2018
Training for the introduction of Inactivated Poliovirus Vaccine, Fractional Dose (fIPV)
Module 2
IPV attributes and storage requirements

2. Learning objectives
At the end of the module, the participant will be able to:
Describe the main attributes of IPV
Describe the correct storage conditions for IPV
Duration
15 minutes

3. Key issues 1 2 3 4 What is inactivated poliovirus vaccine (IPV)?
At which temperature should IPV be stored? 2
Where should IPV be stored? 3
How safe is IPV? 4
To the facilitator:
Explain to the participants the key issues raised in this module.
This module will explain how to store the vaccine.
We will provide you with answers to the following questions:
What is inactivated poliovirus vaccine presentation?
At which temperature should the vaccine be stored?
Where should the vaccine be stored?
How safe is inactivated poliovirus vaccine?

4. IPV compared to fractional IPV (fIPV)
Volume per dose
0.5 mL
0.1 mL
Schedule
1 dose: 14 weeks
2 doses: 6 and 14 weeks
Administration
Intramuscular (IM) injection
Intradermal (ID) injection
Site of administration
Thigh
Upper arm
Syringe
0.5 mL AD syringe
0.1 mL AD syringe
Are two fractional doses as effective as a single standard dose?
Two fractional doses of IPV (ID) given at 6 and 14 weeks produces better immunogenicity than a single standard dose (IM) given at 14 weeks
To the facilitator:
Describe to the participants that IPV can either be administered as a standard 0.5mL dose or a FRACTIONAL DOSE which is 0.1mL
A fractional dose represents 1/5 (one-fifth) of a single standard dose
Our country is introducing IPV as a fractional dose, with a 2-dose schedule.
More details on administration of fractional dose will be covered in Module 4. 4

5. Is fractional dose IPV as effective as full dose IPV?
Author
Year published
Country
Schedule
One full-dose IPV
Two fractional doses given intradermally
Resik S
2013
Shown above
Cuba
IPV
63% (4 mos)
98% (4+8 mos)
Anand A
2015
Bangladesh
39% (6 wks)
81% (6+14 wks)
2016
In publication
73% (14 wks) --
To the facilitator:
Describe to the participants that data has shown that two (2) fractional doses of IPV, given intradermally, actually provide better seroconversion than a single full-dose of IPV.
 Two fractional doses are more immunogenic

6. What is the presentation of IPV?
Liquid suspension providing protection against all 3 types of poliovirus
Does not require reconstitution
IPV comes in single, 5 (2.5 mL) or 10 (5 mL) standard dose vials
When using a two-dose fractional dose schedule:
A fractional dose represents 1/5 (one-fifth) of a single standard dose
5 dose vial will become a 25 fractional dose vial (0.1 mL per dose)
To the facilitator:
Describe to the participants the inactivated poliovirus vaccine presentation.
Inactivated poliovirus vaccine is a suspension for use by injection. IPV does not need reconstitution.
It comes in a suspension in a vial, ready for injection as single or multi dose vial (5 or 10 doses).
Presented in a 2.5 mL multidose vial (vial of 5 doses of 0.5 mL each) or a 5 mL multidose vial (vial of 10 doses of 0.5 mL each) – box of 10
A fractional dose represents 1/5 (one-fifth) of a single standard dose
FRACTIONAL DOSE: Using a standard 5 dose vial will yield up to 25 fractional doses (0.1 mL each) 6

7. IPV has high heat sensitivity
IPV has greater susceptibility to heat than many existing heat sensitive vaccines
VVM on IPV may change color faster than other vaccines
Proper temperature monitoring and stock management is required to avoid wasting IPV vials with VVM reaching the discard point
While the “earliest expiry, first out” principal usually applies in vaccine stock management, the status of a VVM overrules this, whereby any batch showing a darker VVM should be used sooner, regardless of a later expiry date
To the facilitator:
Explain to the participants at which temperature the vaccine should be stored.
Handling vaccines requires great care. Careful storage and transport conditions are needed to protect vaccines from becoming ineffective and unusable.
IPV is heat sensitive. Inactivated poliovirus vaccine must be transported and stored at +2°C to +8°C. IPV has increased susceptibility to heat than some other heat sensitive vaccines therefore VVM on IPV may change color faster than other vaccines
It is important to monitor refrigerator temperature regularly and Check VVM status, use first vials with VVM that have started to change color
Proper stock management and temperature monitoring is required to avoid wasting IPV vials with VVM reaching the discard point.
While the “earliest expiry, first out” principal usually applies in vaccine stock management, the status of a VVM overrules this, whereby any batch showing a darker VVM should be used sooner, regardless of a later expiry date 7

8. IPV is freeze sensitive
IPV is freeze sensitive (unlike OPV)
the “shake test” is not effective in determining whether IPV has been frozen
Therefore it is very important that if there is any suspicion that IPV has been frozen, the vial must be discarded
To the facilitator:
Explain to the participants at which temperature the vaccine should be stored.
Handling vaccines requires great care. Some vaccines are sensitive to heat and some to freezing.
Careful storage and transport conditions are needed to protect vaccines from becoming ineffective and unusable.
IPV is freeze sensitive (unlike OPV which can be frozen). It is important to ensure that the vaccine is not frozen.
If vaccines are frozen, they lose their potency and they would not provide adequate protection against the disease. Previously frozen vaccines may also cause "aseptic abscesses." Because stand-alone IPV is not an
Do NOT Freeze IPV! If Frozen, Discard.
As IPV is an adsorbed vaccine (i.e., no aluminum adjuvant), the "shake test" is ineffective in determining whether IPV has been frozen.
If there is doubt or suspicion that IPV was frozen, the vial must be discarded. 8

9. Where do you store the vaccine?
Store IPV in a refrigerator, between +2⁰C and +8⁰C
Do not open the door frequently
Monitor fridge temperature regularly
Do not put IPV in the freezer
To the facilitator:
Explain to the participants where to store the vaccine.
Good temperature control during the storage and transport of vaccines is critical to ensure their potency and safety. Monitor the temperature of the refrigerator regularly.
As we have mentioned before, IPV must be stored between +2°C and +8°C .
Do not put inactivated poliovirus vaccine in the freezer.
The vaccine should be administered as soon as possible after being removed from the refrigerator. 9

10. Storing Principles Maintain the cartons in a neat row
Store similar vaccines in the same area to facilitate easy identification
Keep ~2 cm of space between rows for circulation of air
Record the period of time the vaccine has been in storage
In top-opening refrigerators, store IPV and other freeze-sensitive vaccines on top.
In front-opening refrigerators store IPV and other freeze-sensitive vaccines on the lower shelves
Remember: IPV may be freeze damaged if placed in close contact with icepacks in cold boxes and carriers.
Condition ice packs before use: keep packs at room temperature until they begin to melt, before placing them in the cold boxes and carriers.

11. Which vaccine should be stored in front?
Vaccines with later expiration dates should be stored in the back
Vaccines with earlier expiration dates and VVM at or near Stage 2 should be kept in front and used first
To the facilitator:
Explain to the participants, how to store the vaccine.
Remember the Earliest Expiry First Out (EEFO) principle. Vaccines with early expiration dates should be kept in front for first use.
Vaccines with the Vaccine Vial Monitor (VVM) at or near stage 2 should be used first. Vaccines with VVM beyond stage 2 should not be used even if the expiration date is valid (more detail in Module 4).
Keep a “use first box” in the refrigerator to put vaccine vials that were taken out of the refrigerator (for fixed or outreach session) and were brought back unused. Vaccines in the “use first box” must be used first in the next session.
Do not open the refrigerator door often and regularly monitor the temperature of the refrigerator.
Earliest Expiry First Out (EEFO)
Principle 11

12. What should you do?
For some VVMs on IPV vials, the inner square is getting darker but is still lighter than outer square
What should you do?
To the facilitator:
Read the slide.
The question will test if participants understand what to do if the refrigerator stops functioning.
Answer:
VVM in IPV may change color faster than some other vaccines.
Use vials that have started to change color first, if the VVM has not reached the discard point and expiry date is valid.
Make sure that the refrigerator temperature is maintained at 2-8 degrees 12

13. The refrigerator stops functioning
What should you do?
The refrigerator stops functioning
What should you do?
To the facilitator:
Read the slide.
The question will test if participants understand what to do if the refrigerator stops functioning.
Answer:
Find another refrigerator or cold room to store vaccines (be sure that the temperature is maintained between +2°C and + 8°C).
If another refrigerator is unavailable, line ice packs or cold packs in cold box(es) or vaccine carrier(s) then put vaccines in the box(es) (Be careful not to put inactivated poliovirus vaccines or other freeze-sensitive vaccines near frozen ice packs, as it may affect vaccine potency).
Inform supervisor immediately. 13

14. How safe is IPV vaccine? IPV is one of the safest vaccines
Infrequently reported side effects: swelling, redness and pain at injection site, fever and discomfort
IPV may be given with other vaccines in the infant Expanded Program on Immunization (EPI) schedule without interfering with their effectiveness
Incidence of Adverse Events does not increase when IPV is given in the same session (either as stand-alone or in combination vaccines)
To the facilitator: explain to the participants that the new inactivated poliovirus vaccine is safe.
Current inactivated poliovirus vaccines are generally well tolerated. They do not appear to cause many serious adverse events.
Swelling, redness and pain on injection site as well as fever, discomfort are seldom occurring side effects
Local reactions:
Low (<5% overall): Swelling, redness and pain on injection site.
Systematic reactions:
Seldom (>1/10.000, <1/1.000)): Fever, discomfort.
Neural disorders:
Very Seldom (< 1/10.000): (Poly-) Neuropathy
Respiratory, thoracic and mediastinal disorders:
Apnoea in very premature infants (≤ 28 weeks of gestation)
The incidence of Adverse Events with other vaccines (e.g. penta, PCV) are the same  (or do not increase) when IPV is given in the same session (either as stand-alone or in combination vaccines).
Any adverse events and other problems related to the vaccines should be reported through the existing AEFI Reporting System established by the National Immunization Program (more details in Module 6).
Inactivated poliovirus vaccine can be given safely with other vaccines. 14

15. Key messages IPV is a liquid, injectable formulation
Vaccine comes in 5 or 10 dose vials - A standard 5 dose vial yields up to 25 fractional doses (0.1 mL each)
Injection site soreness and fever are most common reactions
Store vaccines between +2⁰C and +8⁰C, never freeze
“Shake Test” is not effective in determining whether IPV has been frozen
Condition ice packs before using in cold boxes or vaccine carriers
Keep vaccines with early expiration dates and VVM at or near stage 2 in front of the refrigerator and use first
Regularly monitor the temperature of the refrigerator
To the facilitator:
Explain to the participants that these are the important things to keep in mind.
IPV is a liquid, injectable formulation
Vaccine comes in 5 or 10 dose vials – FRACTIONAL DOSE: A standard 5 dose vial yields up to 25 fractional doses (0.1 mL each)
Injection site soreness and fever are most common reactions to IPV
Store vaccines between +2⁰C and +8⁰C
Keep vaccines with early expiration dates and VVM at or near stage 2 in front of the refrigerator and use first
Do not open the refrigerator door often
Regularly monitor the temperature of the refrigerator

16. End of module for your attention! Thank you To the facilitator:
This is the end of the module.
You have been introduced to “Inactivated poliovirus vaccine attributes and storage conditions”.
The following module is titled “Inactivated poliovirus vaccine eligibility”.
Thank you for your attention!