IPV (INACTIVATED POLIOVIRUS VACCINE)

Type of Vaccine
Inactivated polio virus (killed virus)

COMPOSITION
Inactivated poliovirus type 1 - 40 D antigen units
Inactivated poliovirus type 2 - 8 D antigen units
Inactivated poliovirus type 3 - 32 D antigen units

Number of doses per vial
Vaccine comes in: 1-dose, 5-dose, and 10-dose vials
The Government of India is acquiring 5-dose and 10-dose vials currently

Type of vaccine vial monitor (VVM) on the vial
Type 7

Reconstitution
No reconstitution is required as IPV is a liquid vaccine

Dose
0.5 ml for full dose which is administered by intramuscular route
0.1 ml for Fractional dose which is administered by intradermal route

Route of administration
Intramuscular for full dose
Intradermal for fractional dose

Site of administration
The full intramuscular dose is given in the anterolateral aspect of RIGHT thigh
The fractional intradermal dose is given on the RIGHT upper arm

Schedule of immunization under UIP
IPV was launched as a single IM dose to be administered at 14 weeks of age along with OPV-3 in 6 states.
Note: Later on, in the remaining states/UTs, IPV has been launched as Two-dose fractional intradermal schedule at 6 & 14 Weeks.

What is the reason for shifting from one full IM dose to two fractional ID dose schedule?
• The change was driven by the scarcity of IPV globally.
• Moreover, WHO reports that Two fractional doses of IPV, given at 6 and 14 weeks produce better immunogenicity than a single standard dose (IM) given at 14 weeks.
Hence only 0.2 ml is needed per child when two fractional doses are given instead of one full IM dose where 0.5 ml is required per child.

Contraindications
1. Known or documented allergy to vaccine components:
a. Streptomycin
b. Neomycin
c. Polymixin – B
2. History of allergic reaction to previous IPV injection
3. Thrombocytopenia
4. Any other bleeding disorder
5. Temporarily taking immunosuppressant, as this can suppress the immune response to the vaccine.
• Postpone the vaccination until the end of the treatment to ensure full protection by the vaccine

Is a booster dose recommended?
No, currently no booster dose is recommended under UIP.

Storage:
Between +2⁰C and +8⁰C,
In the Ice line refrigerator, IPV is stored in the basket
In a refrigerator, store in the middle compartment, along with DPT, TT and pentavalent vaccines
• Do not open the door frequently (not more than 3 times/ day)
• Monitor and record the fridge temperature twice daily
Do not put IPV in the freezer

Is IPV freeze sensitive?
Yes, 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, if there is ANY suspicion that IPV has been frozen, the vial MUST be DISCARDED

Where the IPV vaccine should be kept at the immunization session?
IPV should NOT be kept on the ice pack during an immunization session; it should be placed on the table.

Is the vaccine eligible for ‘Open Vial Policy’?
Yes.
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:
1. The vaccine is currently prequalified by WHO.
2. The vaccine is approved for use for up to 28 days after opening the vial, as determined by WHO.
3. The expiration date of the vaccine has not passed.
4. The vaccine vial has been, and will continue to be, stored at WHO- or manufacturer-recommended temperatures.
5. The cap of the vaccine has not been submerged in water.
6. Any vaccine vial missing a label, or attached with a label that cannot be read, should never be used.
7. The vials are handled with good hygienic practices.

What is the maximum age limit for giving the first dose of IPV?
Under UIP, the maximum age limit for IPV is one year.

What are the common side-effects of IPV?
IPV is one of the safest vaccines
Infrequently reported side effects:
• Swelling, redness and pain at injection site,
• Fever and
• Discomfort

Protective efficacy
More than 90%

Are two fractional doses as effective as a single standard intramuscular dose?
Two fractional doses of IPV, given at 6 and 14 weeks produce better immunogenicity than a single standard dose (IM) given at 14 weeks.
The minimum interval between two doses of IPV should be 8 weeks

Q. How to administer IPV by intradermal route?
IPV will be administered in a similar way as BCG vaccine is given. 0.1 ml of vaccine from a multi-dose vial will have to be administered using BCG needle and syringe at right deltoid muscle in upper arm. So, 50 doses can be obtained from a single 5.0 ml multi-dose vial (as against 10 doses if given IM)

Q. Why was the need felt to introduce IPV in the National immunization schedule?
1. Though OPV offers effective protection against polio, but in very rare cases it can itself lead to paralysis
a. Vaccine virus can spontaneously change and become capable of causing disease (Vaccine Associated Paralytic Polio or VAPP)
o A large proportion of this is from type 2 OPV
b. Rare outbreaks are caused by person-to-person spread of vaccine strain, which mutates/changes to a highly transmissible form capable of causing disease (Circulating Vaccine Derived Poliovirus or cVDPV)
o 97% of these outbreaks are from type 2 OPV virus
c. On the other hand WILD type 2 poliovirus has been eliminated since 1999

2. To solve the problem of VAPP and cVDPV, a step is being taken to ‘SWITCH’ from trivalent Oral Poliovirus Vaccine (t OPV) to bivalent Oral Poliovirus Vaccine (b OPV) at the global level.
This switch will solve the problem of VAPP & VDPV to a great extent but at the same time
o The immunity of the subsequent birth cohorts against strain 2 will plummet due to the absence of the same from the vaccine and
o There is a risk of outbreaks of cVDPV type 2 as it is circulating in the population due to use of t OPV in the national programme.
The strategy to tackle this threat is simultaneous introduction of IPV in the immunization schedules because:
o It does not have potential to cause VAPP or VDPV (as it is a killed vaccine) and
o It will maintain the immunity level of the population against all the three strains of the virus (since it has all 3 strains)

Will IPV (injection) replace OPV (drops)?
No, IPV will not replace OPV, since IPV is recommended to be administered in addition to OPV.

Is it safe to give IPV and OPV together?
Yes, it is absolutely safe to give IPV and OPV together. Evidence shows that when IPV is used along with OPV, it builds better mucosal (intestinal) immunity than when OPV is used alone;
Hence to maximize childhood immunity and move towards global polio eradication, it is recommended that both vaccines be used together.

References:
1. GOI. Immunization Handbook for Medical Officers. New Delhi: Department of Health and Family Welfare; 2016.
2. IPV Training Modules and Communication Documents, Pan American Health Organization (PAHO) website. Available at: http://www.paho.org/hq/index.php?option=com_content&view=article&id=1046... , accessed on 18th October 2017
3. Immunization Standards: WHO website. Available at: http://www.who.int/immunization_standards/vaccine_quality/pq_232_ipv_1do..., accessed on 18th October 2017
4. Pragya S, Akanksha R, Taneja DK, Suneela G (2016) Implications of IPV Introduction in National Immunization Schedule Page 2 of 3 and Strategies to Combat Shortages. Int J Vaccine Res 1(2): 3.
5. Fractional Dose IPV. Immunization, Vaccine and Biologicals: World Health Organization website. Available on: http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective... , accessed on 18th October 2017
6. GOI, 2016. Mission Indradanush, Operational Guidelines. Ministry of Health and Family Welfare, New Delhi.

7. Vipin M V et al. 2016. Introduction of Inactivated Poliovirus Vaccine in National Immunization Program and Polio Endgame Strategy, VOLUME 53, SUPPLEMENT 1. AUGUST 15, 2016: 65-69

National Immunization Schedule in India; 2017: http://www.ihatepsm.com/blog/national-immunization-schedule-india-2017

Rotavirus vaccine: http://www.ihatepsm.com/blog/rotavirus-vaccine

Pentavalent vaccine: http://www.ihatepsm.com/blog/pentavalent-vaccine

BACILLE CALMETTE GUERIN (BCG) VACCINE: http://www.ihatepsm.com/blog/bacille-calmette-guerin-bcg-vaccine

IPV (INACTIVATED POLIOVIRUS VACCINE): http://www.ihatepsm.com/blog/ipv-inactivated-poliovirus-vaccine

DT & TT Vaccines: http://www.ihatepsm.com/blog/dpt-and-tt-vaccines

Oral Polio Vaccines (OPV): http://www.ihatepsm.com/blog/oral-polio-vaccines-opv

Measles Containing Vaccines (MCV): http://www.ihatepsm.com/blog/measles-containing-vaccines-mcv

HEPATITIS B VACCINE: http://www.ihatepsm.com/blog/hepatitis-b-vaccine

JAPANESE ENCEPHALITIS (JE) VACCINE: http://www.ihatepsm.com/blog/japanese-encephalitis-je-vaccine

Pneumococcal Conjugate Vaccine (PCV): http://www.ihatepsm.com/blog/pneumococcal-conjugate-vaccine-pcv

RABIES VACCINE: http://www.ihatepsm.com/blog/rabies-vaccine