Immunization Systems Management Group (IMG)

Immunization Systems Management Group (IMG)
Inactivated Polio Vaccine (IPV) Comprehensive technical module Rationale for IPV introduction & OPV withdrawal in relation to Objective 2 of The Polio Eradication & Endgame Strategic Plan Immunization Systems Management Group (IMG) Version date: February 10, 2014 © 2012 IMG 1

Glossary of terms & abbreviations
cVDPV Circulating Vaccine-Derived Poliovirus DTP3 Diphtheria Tetanus Pertussis (third dose) GPEI Global Polio Eradication Initiative IMG Immunization Systems Management Group IPV Inactivated Polio Vaccine OPV Oral polio vaccine bOPV (bivalent, contains types 1 and 3) mOPV (monovalent) OPV1 (type 1 component of OPV) OPV2 (type 2 component of OPV) OPV3 (type 3 component of OPV) SAGE Strategic Advisory Group of Experts on Immunization VAPP Vaccine-associated paralytic poliomyelitis VDPV Vaccine-derived poliovirus WHA World Health Assembly WHO World Health Organization WPV Wild poliovirus IPV introduction

Definitions Technical term Definition (in the context of these slides)
Fractional Dose A fractional dose is a dose that uses less antigen (1/5th or 1/3rd) for cost or supply sparing measures. With IPV, fractional doses are being evaluated by administration into the skin (intradermal, ID). In contrast, full dose is usually administered into the muscle (intramuscular, IM) or subcutaneous tissue (SC or SQ). Intestinal Immunity Intestinal shedding refers to the amount of virus an infected person “sheds” or passes on through their intestine (and fecal matter). Wild polioviruses and vaccine viruses can be spread from person to person this way, if there is no intestinal immunity. In developing countries the major mode of transmission is thought to be fecal shedding to others with oral ingestion. Oral-pharyngeal shedding Oral-pharyngeal shedding refers to the amount of virus an infected person “sheds” or passes on through their oral secretions (nose and mouth). In industrialized countries the major mode of transmission is thought to be oral secretion to oral ingestion. Priming Children who do not seroconvert after a first dose are considered primed if they seroconvert within 7 days of a 2nd dose. Seroconversion Seroconversion is defined as the development of antibodies in blood serum as a result of infection or immunization and is correlated with protection IPV introduction

Objectives of this module
Provide Technical background on Polio & Polio vaccines as it relates to Objective 2 of GPEI’s Polio Eradication & Endgame Strategic Plan Review Rationale for OPV cessation Review Rationale for IPV introduction Review of SAGE recommendations for IPV introduction Note: this is a comprehensive stand-alone deck of slides with an accompanying document IPV introduction

Key messages for IPV introduction & OPV cessation
IPV recommended by SAGE All countries introduce at least one dose of IPV into the routine immunization system before the tOPV-bOPV switch OPV cessation crucial OPV cessation must occur for the world to be polio free because OPV in rare cases can cause paralytic disease OPV cessation--2 phases Removal of type 2 in 2016 (tOPV to bOPV switch globally) bOPV cessation in (complete cessation of OPV) IPV rationale Ensures that a substantial proportion of the population is protected against type 2 polio after OPV2 cessation Added IPV benefits Mitigates risks of type 2 reintroduction in association with OPV2 cessation & facilitates polio eradication by boosting immunity to types 1&3 IPV clarifications Recommended for routine immunization…not campaigns Recommended in addition to OPV…not replacing any OPV 9/18/2018 IPV introduction

GPEI Accomplishment: Significant Decline in Polio-paralyzed Children, 1988-2013*
*as of 31 December 2013 9/18/2018 IPV introduction

As wild polioviruses are eradicated, number of vaccine-derived cases exceeds wild poliovirus cases
A hypothetical scenario of estimated VDPV cases compared to reported cases of wild poliovirus (as of 31 December, 2013) 9/18/2018 IPV introduction

The Polio Eradication & Endgame Strategic Plan 2013-2018
The Plan differs from previous eradication plans “complete the eradication and containment of all wild, vaccine-related, and Sabin polioviruses such that no child ever again suffers paralytic poliomyelitis.” 9/18/2018 IPV introduction

The Plan has four objectives
Detect and interrupt all poliovirus transmission 1 Strengthen immunization systems, withdraw oral polio vaccines (OPV), and introduce inactivated polio vaccine (IPV) 2 Contain poliovirus and certify interruption of transmission 3 Plan polio’s legacy 4 9/18/2018 IPV introduction

Ongoing STRENGTHENING of routine immunization services
Objective 2 of The Plan addresses the Endgame through three distinct stages Introduction at least one dose of IPV into routine immunization Switch tOPV to bOPV Withdrawal of bOPV & routine OPV use 2016 Before end 2015 Ongoing STRENGTHENING of routine immunization services 9/18/2018 IPV introduction

Timeline for implementation of Objective 2, the Endgame
Global certification Stop bOPV : withdrawal of bOPV after the world is certified polio-free in 2018 tOPV-bOPV switch 2016: tOPV-bOPV switch globally Last wild polio case Anticipated timeline Phase in IPV Before end of 2015: introduce one dose of IPV in immunization programs of all countries, prior to tOPV-bOPV switch IPV in routine immunization 9/18/2018 IPV introduction

Technical Rationale for Oral Polio Vaccine (OPV) Cessation
Key Messages Because OPV in rare cases can cause paralytic disease, OPV cessation must occur for the world to be polio free. OPV cessation will occur globally in two phases: removal of type 2 component (switch from tOPV to bOPV) in 2016 followed by bOPV withdrawal and cessation of OPV use in 9/18/2018 IPV introduction

Oral Polio Vaccines (OPV) in routine and supplementary immunization activities globally
Types of OPV Trivalent OPV (tOPV): types 1, 2, and 3 Bivalent OPV (bOPV): types 1 and 3 Monovalent OPV (mOPV): types 1 or 2 or 3 Currently, TRIVALENT is the most commonly used OPV in routine immunization globally, while BIVALENT is more commonly used in supplementary immunization activities. IPV introduction

Wild OPV related VAPP** VDPVs* Types of polioviruses
99% reduction in cases of wild poliovirus since 1988 Type 1 (341 cases as of 20 November 2013†) Type 2 (eliminated worldwide in 1999) Type 3 (none detected since November 2012) VAPP** Vaccine-associated paralytic poliomyelitis (VAPP)** Estimated ~ globally per year Type 2 accounts for about 40% of VAPP OPV related VDPVs* Vaccine derived polioviruses (VDPV) Most are circulating VDPVs (cVDPVs)* ~ per year since 2008 (through 20 Nov 2013) Type 2 cVDPVs account for 97% of cVDPVs † More up-to-date numbers can be found at *Other extremely rare VDPVs include primary immunodeficiency VDPVs (iVDPVs) and ambiguous VDPVs (aVDPVs) **Refers to spontaneous reversion to neurovirulence of one of the attenuated viruses in OPV. VAPP occurs in OPV recipients or their close contacts in contrast to cVDPVs which are widely transmitted in a community and are not likely to be related to contact with a recent vaccine recipient. IPV introduction © 2012 IMG

What does it mean for the world to be polio-free?
Complete interruption of transmission and elimination of all polio disease Wild polioviruses Vaccine-derived polioviruses (VDPVs) Vaccine-associated paralytic poliomyelitis (VAPP) Eradication & Endgame Strategic Plan refers to both wild and vaccine-derived polioviruses Eradication Plan refers to wild virus Endgame Plan refers to management of VDPVs and VAPP IPV introduction

Wild poliovirus still circulating
Rationale for continuing use of OPV until Polio Eradication & Global Certification As long as there are susceptible persons in other countries, there is risk of export of the virus to these countries.” Endemic in 3 countries – reservoirs for re-infecting others (Pakistan, Afghanistan, Nigeria) In 2013, polio cases in 5 other countries previously polio free countries (Somalia, Kenya, Ethiopia, Cameroon, Syria) Wild poliovirus still circulating OPV is a critical component of the eradication strategy until polio transmission is interrupted globally & the world is certified polio-free, Risk of polio spread into other regions of the world is real without the continued use of OPV Eradication requires OPV OPV is appropriate for eradication Inexpensive Easy to administer Offers good oral and intestinal immunity—needed for interruption of person to person transmission IPV introduction

Phase 1 2016 Phase 2 2019-2020 OPV withdrawal Type 2 All OPV
Objective 2 of the Plan calls for a phased withdrawal and containment of OPV globally OPV withdrawal Remove type 2 by switch from tOPV to bOPV… Phase 1 2016 Type 2 …followed by bOPV withdrawal and cessation of OPV use in Phase 2 All OPV IPV introduction

Rationale for removing type 2 component of OPV (OPV2)
Risks of OPV2 far outweigh the benefits Thus, need to remove OPV2, but need to maintain population immunity against type 2 with IPV prior to OPV2 cessation Type 2 poliovirus apparently eradicated since 1999 (last case detected in Aligarh, India) New diagnostics and experience suggest that type 2 cause >95% of cVDPVs Type 2 causes 40% of VAPP today Type 2 component of OPV interferes with immune response to types 1 and types 3 IPV introduction

Rationale for retaining Types 1 & Types 3 components of OPV (bivalent OPV) until global certification of polio eradication Type 1 causes all polio cases related to wild virus today Few VDPV cases are type 1 Few VAPP cases in immunocompetent individuals Type 3 last detected in November, 2012 (as of 20 November 2013) Few VDPV cases are type 3 Most VAPP cases (60%) in immunocompetent persons are type 3 While lack of detection since November 2012 is promising, the period without detection to date is not long enough to assume eradication—due to potential silent transmission, certification of eradication requires at least 3 years without detection of virus. IPV introduction

Risks associated with OPV2 cessation
Two main risks are associated with OPV2 cessation These risks are mitigated by strengthening routine immunization and introduction of IPV Short-term risks Time-limited risk of cVDPV2 emergence, highest 1-2 years after OPV2 cessation Medium & long term risks Poliovirus re-introduction from a vaccine manufacturing site, research facility, immune deficient persons, diagnostic laboratory, or bioterrorism IPV introduction

Role of OPV post-eradication
POLIO OUTBREAK post-eradication mOPV1 mOPV2 mOPV3 Maintaining a stockpile of monovalent OPVs (mOPV1, mOPV2, mOPV3) Using mOPVs to control outbreaks of cVDPVs or re-introduction from a manufacturing site, research facility, or diagnostic laboratory Stockpile of mOPVs would allow a type-specific response for rapid interruption of outbreak IPV introduction

Technical Rationale for Introduction for Inactivated Polio Vaccine (IPV)
Key Messages Introducing IPV before the tOPV-bOPV switch in 2016 will ensure that a substantial proportion of the population is protected against type 2 polio after OPV2 cessation and mitigate risks associated with OPV2 cessation IPV is recommended for routine immunization programmes & not campaigns IPV is given in addition to OPV doses and does not replace any OPV doses 9/18/2018 IPV introduction

Planned use of IPV: SAGE Recommendations
SAGE recommended that all countries introduce at least 1 dose of IPV in their routine immunization programmes to mitigate the risks associated with the withdrawal of type 2 component of OPV Single dose of IPV at 14 weeks of age with DTP3, in addition to OPV3 or OPV4. Countries have flexibility to consider alternative schedules All endemic and other high risk countries should develop a plan for IPV introduction by mid-2014 and all OPV-only using countries by end-2014 WER, 3 Jan 2014, vol. 89, 1 (pp 1-20): at 9/18/2018 IPV introduction

Features of Inactivated Polio Vaccine (IPV)
Not a live vaccine – no risk of VAPP or VDPVs Must be administered by intramuscular or subcutaneous injection Trivalent – produces antibodies to types 1, 2 and 3 poliovirus A high proportion of vaccinees, generally > 95% of children, have serum neutralizing antibodies after 3 doses to all three polio serotypes Appears equivalent to OPV in inducing pharyngeal immunity Inferior to OPV in inducing gut immunity More costly to produce than OPV Partners are working towards achieving the lowest possible price for GAVI and non-GAVI countries. Collaborations & investigations underway to explore two “low cost” IPV options: fractional dose intradermal adjuvanted intramuscular IPV GAVI will cover the full cost of purchase for GAVI eligible and graduating countries 9/18/2018 IPV introduction

Interrupt transmission if outbreaks occur
Rationale for introducing at least one dose of IPV prior to the tOPV-bOPV switch Introducing IPV before the tOPV-bOPV switch in 2016 will ensure that a substantial proportion of the population is protected against type 2 polio after OPV2 cessation. One dose of IPV will: Reduce risks Hasten eradication Interrupt transmission if outbreaks occur Reduce risks associated with OPV2 cessation Lower risk of re-emergence of type 2 polioviruses Facilitate interruption of transmission with the use of monovalent OPV2 if type 2 outbreaks occur Boost immunity against types 1 & 3 thus hastening polio eradication IPV At least 1 dose of IPV used globally would improve population immunity Reduces the consequences of type 2 re-emergence by inducing population immunity Seroconversion* is generally 32-65% for the first dose of IPV Virtually all who do not seroconvert are still immunologically primed** and may be protected against clinical polio In the event of a type 2 polio outbreak as a result of reintroduction of the type 2 viruses a significant proportion of children who have received IPV would already be immune a dose of mOPV2 in an SIA for outbreak response would lead to higher immunity levels in a population that has received 1 dose of IPV previously than use of mOPV2 in a naïve population because these children will have received 2 doses of a polio containing vaccine instead of just the 1 dose administered in an SIA IPV boosts systemic immunity (protects against paralytic disease) and intestinal immunity (reduces transmission) in OPV primed populations to all vaccine types contained in prior OPV doses - i.e. it will boost immunity to types 1 and 3, hastening interruption of transmission and providing insurance against reintroduction from other populations. IPV introduction

Individual protection against paralytic disease induced by IPV – REDUCE RISKS Reduce risks Hasten eradication Interrupt transmission if outbreaks occur IPV IPV introduction

Impact of one dose of IPV*
Primary role of one dose of IPV is intended to be a RISK MITIGATION strategy to reduce risk of re-emergence of type 2 polioviruses after OPV2 cessation Seroconversion against type 2 after one dose of IPV ranges from 32-63%. Persons who seroconvert should be protected against paralytic polio Seroconversion rates are higher when vaccine is administered later in infancy presumably because of waning maternal antibody Persons who seroconvert should be protected against paralytic polio Author year Country Schedule Type 2 Seroconversion Intramuscular administration of 1 dose of IPV McBean 1988 US 2 mo 35% Simasathien 1994 Thailand 39% Resik 2010 Cuba 6 wk 36% Mohammed 2010 Oman 32% Resik 2013 4 mo 63% * Estı´variz CF et al. Lancet 2012; 12(2):128-35 IPV introduction

Rationale for administering IPV after 14 weeks of age, in the context of the Endgame Plan
The immune response to intramuscularly administered IPV varies based on the number of administered doses (higher with more doses) and the age at vaccination (higher with delayed immunization). 3 doses: ~100% against all 3 serotypes 2 doses: ~90% against all 3 serotypes, when administered >8 weeks of age 1 dose: ~19%-46% against Type 1, 32%-63% against Type 2, and 28%- 54% against Type 3 poliovirus. It is important to note that immune response to one dose of IPV is substantially higher, particularly against Type 2 poliovirus (63%) when administered at 4 months of age compared to 6 weeks to 2 months of age (32%-39%). Thus, SAGE recommends a single dose of IPV at 14 weeks or first contact afterwards, or with DTP3/OPV3 or for countries administering a birth dose of OPV, at the time of the OPV4 dose IPV introduction

Poliovirus type 2 seroconversion & priming
In a study from Cuba, among those who did not seroconvert after 1 dose of IPV, 98% had a priming response to a subsequent dose of IPV--that is, they developed significant antibody responses within 7 days of subsequent exposure to IPV. Persons without priming who are seronegative would not be expected to make detectable antibody for at least days or longer after immunization. Persons who are seronegative but primed may also be protected against paralytic polio although data are conflicting as to whether priming alone is protective. IPV administered at 4 months of age (n=153) 1st dose seroconversion 63% Priming 98% 1st dose seroconversion & priming 99% Sutter RW – Presentation to SAGE IPV Working Group June 2013 based on: Resik S et al N Engl J Med 2013;368:416-24 IPV introduction

IPV Evidence: One IPV dose prevents VAPP in Hungary
IPV Evidence: One IPV dose prevents VAPP in Hungary. Implies priming induces clinical protection. In 1992, single-dose IPV at 3 mos of age, before OPV receipt VAPP number of cases In 2006, IPV-only schedule Year Sutter RW – Presentation to SAGE IPV Working Group June 2013 In contrast, effectiveness against type 1 in Senegal was 36% (0%-67%) implying that seroconversion is the predictor of immunity. IPV introduction

Outbreak control with mOPV2 in a population which previously received IPV -- REDUCE RISKS Reduce risks Hasten eradication Interrupt transmission if outbreaks occur IPV

IPV Evidence: What impact is one dose of IPV in routine immunization likely to have during SIAs in outbreak situations? Impact on seroconversion of IPV followed by OPV is similar to IPV-IPV or OPV-OPV Thus, with one dose of IPV a proportion of the population is already immune. Use of mOPV in an outbreak control setting in a population who received a dose of IPV is likely to lead to higher immunity levels than a single dose of mOPV in a completely susceptible population Thus, population immunity thresholds to terminate poliovirus transmission are more likely to be reached after a dose of IPV followed by mOPV compared to a single dose of mOPV only in response to an outbreak. Comparison of 2-dose response, Faden et al, JID, **These data are based on a US study in Baltimore and Buffalo. IPV introduction

IPV in reducing transmission of polioviruses – Interrupt Transmission
Reduce risks Hasten eradication Interrupt transmission if outbreaks occur IPV

OPV challenge studies: Shedding of poliovirus in IPV versus OPV vaccinees
IPV is equivalent to OPV in reducing oral shedding but is inferior to OPV in reducing intestinal shedding. To the degree that polioviruses are transmitted orally, IPV should be equivalent to OPV. To the extent that polioviruses are transmitted via the fecal-oral route, IPV is likely to be inferior to OPV. From Vidor E et. al, Poliovirus Vaccine – Inactivated, Vaccines 6th edition, Elsevier, 2013 IPV introduction

Although IPV may not be as effective as OPV in decreasing prevalence of poliovirus excretion in stool, IPV may still decrease transmission IPV does reduce the duration of shedding and the amount of virus shed in the stool. Thus, IPV should decrease the spread of polioviruses if they are introduced, compared to a fully unvaccinated population. From Sutter et al. Poliovirus vaccine-live, Vaccines 6th ed, Elsevier, 2013 IPV introduction

IPV in boosting immunity in OPV primed individuals – Hastens Eradication Reduce risks Hasten eradication Interrupt transmission if outbreaks occur IPV

A single dose of IPV after prior doses of tOPV boosts immunity to types 1 & 3
IPV could also play a role in the eradication efforts, in conjunction with bOPV, by boosting immunity against type 1 and 3 polioviruses in polio endemic countries and countries where poliovirus circulation has been reestablished. Immune response to Types 1 & 3 significantly better with IPV at 6 months of age in children who received three prior doses of tOPV in Ivory Coast but were still seronegative* 3 tOPV + IPV** 3 tOPV + tOPV** Type 1 seroconversion 80% 40% Type 3 seroconversion 76% 22% ** Fourth dose at 6 months Seroconversion after one dose of IPV in seronegative children with prior OPV substantially higher than would be expected with one dose of IPV in polio vaccine naïve children. Further, IPV in persons with prior OPV induces boosts in mucosal immunity. Results from a similar study in Moradabad showed 91%-100% seroconversion for types 3 and 2 respectively among those who received IPV** *Moriniere BJ et al. Lancet 1993;341: , ** Estı´variz CF et al. Lancet 2012; 12(2):128-35, IPV introduction

bOPV + IPV bOPV bOPV + mOPV2 bOPV + IPV + mOPV2
Type 2 Type 3 Type 1 tOPV: 3 rings of protection against types 1, 2, and 3 Schematic description of technical rationale for use of at least one dose of IPV as part of the Endgame Strategy bOPV + IPV bOPV + IPV IPV adds protection against type 2 & boosts immunity to 1 & 3 (enhancing bOPV effect) tOPV-bOPV switch bOPV 2 rings of protection against types 1 and 3 Potential Type 2 outbreak requiring mOPV2 mOPV2 bOPV + mOPV2 Protection against type 2 provided by supplementary use of mOPV2 in the setting of an outbreak mOPV2 bOPV + IPV + mOPV2 bOPV & mOPV2 effect is enhanced in an IPV population thus facilitating outbreak control

IPV Presentations and Formulations
Only WHO prequalified formulation 1-dose and 10-dose available now 5-dose expected in late 2014 Preservative : 2PE does not allow for Multi dose vial Policy application Stand-alone IPV Tetravalent, pentavalent, hexavalent available Combination with whole-cell pertussis not currently available Substantially higher cost than stand-alone IPV Combination products IPV introduction

Example 6-10-14 week schedule with IPV
Vaccine Birth 6 weeks 10 weeks 14 weeks BCG √ DTP-HepB-Hib Pneumococcal Rotavirus* OPV Stand-alone IPV 1st contact after 14 weeks Single dose of IPV at 14 weeks or first contact afterwards All children who are behind on their schedule should receive one dose of the IPV at the first immunization contact after 14 weeks Countries have flexibility to consider alternative schedules (e.g. earlier IPV administration based on local conditions) 9/18/2018 * Rotavirus vaccine may be administered in 2 or 3 doses, depending on the country schedule IPV introduction

Administration of Inactivated Polio Vaccine (IPV)
IPV is administered by intramuscular injection (IM) or subcutaneously (SQ) in a dose of 0.5 ml into the outer part of the thigh When given at the same visit, IPV and other injectable vaccines should be given at different injection sites at least 2 cm apart For example, if IPV, Pentavalent vaccine, and Pneumococcal vaccine are to be given during the same visit, IPV and Pneumococcal should be in one thigh 2 cm apart and the Pentavalent vaccine (more reactogenic) in the other thigh IPV should not be mixed with other vaccines in the same vial or syringe IPV can be administered to prematurely born infants and children with immunodeficiencies (e.g., HIV, congenital or acquired immunodeficiency, sickle cell disease) 9/18/2018 IPV introduction

Multiple Injections: Acceptability and Safety
Recently, more low and middle income countries have begun using multiple vaccine injections with the addition of pneumococcal vaccine and IPV Substantial evidence has reinforced the well-established record of safety and acceptance of multiple injections from countries using multiple injections* For example, US infants often receive 3 or more injections during each of the primary series vaccination visits Giving a child several vaccinations during the same visit offers three major advantages: Immunizing children as soon as possible provides protection during the vulnerable early months of their lives. Giving several vaccinations at the same time means parents and caregivers do not need to make as many vaccination visits. 1 It means that health care providers are able to more efficiently provide and deliver other health services by reducing the time they need to spend providing vaccinations. * * IPV introduction

Specific notes on the recommended IPV schedule*
IPV does not replace ANY of the OPV doses – that is, IPV will be given in addition to OPV and OPV will continue to be used per current practice for now IPV is recommended for routine immunization programmes and not campaigns because injections are difficult to accommodate in campaigns against polio The higher the IPV coverage the better, but even low coverage will provide direct benefit to those vaccinated and greatly facilitate building population immunity in an emergency response Rationale: a major risk factor for IPV failure is persisting maternal antibodies Delaying to DTP3 gives time for maternal antibodies to wane allowing a better immune response to IPV Giving IPV at DTP3 would induce high levels of seroconversion and protection among very young children Delaying the dose to older ages would allow more time for children to be susceptible *from 7th Meeting of the SAGE Polio Working Group, October 18-19, 2013 9/18/2018 IPV introduction

Planned use of IPV: IPV Rationale Summary
IPV induces immunity in a proportion of children which will protect them against polio caused by vaccine viruses (VAPP and cVDPVs) and polio caused by wild poliovirus IPV should lower risk of re-emergence of type 2 polioviruses IPV in conjunction with bOPV will decrease the number of cases of VAPP caused by types 1 and 3 IPV will boost immunity to types 1 and 3 which should hasten eradication of types 1 and 3 wild polioviruses and reduce polio disease caused by types 1 and 3 cVDPVs IPV by inducing immunity to type 2 will facilitate outbreak control with mOPV2 should type 2 viruses be reintroduced A proportion of the population will already be immune resulting in a higher level of immunity after a dose of mOPV2 in outbreak control than after a dose of mOPV2 to contain an outbreak in a completely susceptible population The higher the IPV coverage the better, but even low coverage will provide direct benefit to those vaccinated and greatly facilitate building population immunity in an emergency response This should go up IPV introduction

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