Training for the introduction of Inactivated Poliovirus Vaccine

Training for the introduction of Inactivated Poliovirus Vaccine, Fractional Dose (f. IPV) Module 2 IPV attributes and storage requirements

Learning objectives l 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 l Duration – 15 minutes 2 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

Key issues 1 What is inactivated poliovirus vaccine (IPV)? 2 At which temperature should IPV be stored? 3 Where should IPV be stored? 4 How safe is IPV? 3 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

IPV compared to fractional IPV (f. IPV) IPV Fractional IPV (f. IPV) Volume per dose 0. 5 m. L 0. 1 m. L 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 m. L AD syringe 0. 1 m. L 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 4 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

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 Cuba IPV 63% (4 mos) 98% (4+8 mos) Bangladesh IPV 39% (6 wks) 81% (6+14 wks) Bangladesh IPV 73% (14 wks) -- Shown above Anand A 2015 Shown above Anand A 2016 In publication Two fractional doses are more immunogenic 5 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

What is the presentation of IPV? l Liquid suspension providing protection against all 3 types of poliovirus l Does not require reconstitution l IPV comes in single, 5 (2. 5 m. L) or 10 (5 m. L) standard dose vials l 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 m. L per dose) 6 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

IPV has high heat sensitivity l IPV has greater susceptibility to heat than many existing heat sensitive vaccines l VVM on IPV may change color faster than other vaccines l Proper temperature monitoring and stock management is required to avoid wasting IPV vials with VVM reaching the discard point l 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 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

IPV is freeze sensitive l 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 8 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

Where do you store the vaccine? l Store IPV in a refrigerator, between +2⁰C and +8⁰C l Do not open the door frequently l Monitor fridge temperature regularly l Do not put IPV in the freezer 9 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

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. 10 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

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 Earliest Expiry First Out (EEFO) Principle 11 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

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? 12 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

What should you do? The refrigerator stops functioning What should you do? 13 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

How safe is IPV vaccine? l IPV is one of the safest vaccines l Infrequently reported side effects: swelling, redness and pain at injection site, fever and discomfort l IPV may be given with other vaccines in the infant Expanded Program on Immunization (EPI) schedule without interfering with their effectiveness l Incidence of Adverse Events does not increase when IPV is given in the same session (either as stand-alone or in combination vaccines) 14 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

Key messages l IPV is a liquid, injectable formulation l Vaccine comes in 5 or 10 dose vials - A standard 5 dose vial yields up to 25 fractional doses (0. 1 m. L each) l Injection site soreness and fever are most common reactions l Store vaccines between +2⁰C and +8⁰C, never freeze l “Shake Test” is not effective in determining whether IPV has been frozen l Condition ice packs before using in cold boxes or vaccine carriers l Keep vaccines with early expiration dates and VVM at or near stage 2 in front of the refrigerator and use first l Regularly monitor the temperature of the refrigerator 15 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020

End of module Thank you for your attention! 16 | Inactivated poliovirus vaccine attributes and storage conditions, Module 2 | 24 November 2020