1. World Health Organization
28 April, 2017
Training for Inactivated Poliovirus Vaccine (IPV) introduction
Module 2
Inactivated poliovirus vaccine (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
20 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

4. What is the presentation of inactivated poliovirus vaccine (IPV)?
Liquid suspension providing protection against all 3 types of poliovirus
Presentations: 1-dose, 5-dose and 10-dose vials
Does not require reconstitution
Open multi-dose vials of this vaccine may be used up to 28 days after opening, if all WHO recommendations (listed on next slide) regarding proper storage of the vaccine are fully met. 4

5. Appropriate handling of multi-dose open vials
Open multi-dose vials of this vaccine may be used up to 28 days after opening, if all of the following WHO recommendations are fully met:
The vaccine is currently prequalified by WHO.
 The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO.
 The expiration date of the vaccine has not passed.
 The vaccine vial has been, and will continue to be, stored at WHO- or manufacturer-recommended temperatures.
The cap of the vaccine has not been submerged in water.
Any vaccine vial missing a label, or attached with a label that cannot be read, should never be used.
The vials are handled with good hygienic practices.
1. The vaccine is currently prequalified by WHO. In order for a vaccine to be prequalified, WHO independently evaluates data on vaccine quality, safety and efficacy. This evaluation includes examining the effectiveness of preservatives, as well as the stability of the vaccine under different temperature conditions. In addition, the prequalification program assesses such things as the quality of vials, stoppers, caps and labels.
 2. The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO. For injectable vaccines, this means that the vaccine contains appropriate type and amount of preservative.
 3. The expiration date of the vaccine has not passed. This condition is part of immunization best practice and is included here to emphasize the importance of not using a vaccine vial after the product has expired. The expiration date may be reached over the course of the 28 days so, in line with good practice, the expiration dates of all opened vials should be checked prior to every use.
 4. The vaccine vial has been, and will continue to be, stored at WHO- or manufacturer-recommended temperatures. All vaccines should be stored according to WHO or manufacturer recommended temperatures, normally between +2ºC to +8ºC, and should be protected from freezing and sunlight. If a vaccine vial is labelled as freeze-sensitive and is suspected of having been frozen, or a temperature alarm indicates exposure to sub-zero temperatures, the vaccine should be discarded.

6. IPV is freeze sensitive
IPV is freeze sensitive vaccine (unlike OPV)
the “shake test” is not effective in determining whether IPV has been frozen (Because it does not contain an aluminum adjuvant).
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. 6

7. Where do you store the vaccine?
Store IPV in a refrigerator, between +2⁰C and +8⁰C
Do not open the door frequently (no more than 3x/day)
Monitor and record the fridge temperature twice daily
Do not put IPV in the freezer
IPV+ 7

8. Best practices for storing IPV
Maintain the cartons in a neat row
Keep around 2 cm of space between rows for circulation of air
In front-opening refrigerators store IPV and other freeze-sensitive vaccines on the center shelves.
In top-opening refrigerators, store IPV and other freeze-sensitive vaccines on the upper shelves.

9. Storing Principles
When transporting the vaccines in cold boxes and carriers, IPV should not be placed in direct contact with frozen icepacks, because the vaccine will become damaged.
Follow carefully the step by step recommended procedures for water-icepack preparation before placing them in the cold boxes and carriers.
The water icepacks are ready to be used when there are physical signs of thawing, the frost has disappeared, there are water droplets on the surface and you can hear water shake inside.
Dry the water icepacks, and place them in the vaccine carrier, place the vaccines inside the carrier and assure that the carrier is securely closed.

10. Conditioning of water icepacks

11. Which vaccine should be stored in front?
Vaccines with later expiration dates should be stored in the back
Vaccines with earlier expiration dates 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.
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.
First Expired First Out (FEFO) 11

12. 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 with frozen ice packs, as it may affect vaccine potency).
Inform supervisor immediately. 12

13. 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 with frozen ice packs, as it may affect vaccine potency).
Place a continuous temperature monitoring device or a thermometer for monitoring the temperature.
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 Expanded Program on Immunization (EPI) schedule without interfering with their effectiveness
Incidence of ESAVI does not increase when IPV is given in the same session with other vaccines (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 ESAVI 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
IPV may be used for up to 28 days after opening the vial, if all WHO recommendations on vaccine-storage have been fully met.
Vaccine comes in: 1-dose, 5-dose, and 10-dose vials
Injection site soreness and fever are most common reactions
Store vaccines between +2⁰C and +8⁰C, never freeze
“Shake Test” is ineffective in determining whether IPV has been frozen
Keep vaccines with early expiration dates in the front of the refrigerator and use first
Monitor the temperature of the refrigerator twice daily

16. End of module
Thank you
for your attention!