Immunization, Vaccines and Biologicals

Plan for IPV Introduction

IPV planning

Plan for IPV

For the most part, IPV introduction will involve the same process as other new vaccine introductions. However, there are some notable differences:

Unprecedented timelines - the urgency of eradication necessitates an accelerated introduction plan— all OPV-using countries should introduce a dose of IPV by end-2015;

Global scope - its objective focuses on achieving a global good; and

Lack of direct impact indicators - evaluation will be based on routine immunization coverage in contrast to indicators used to measure the impact of other vaccines (e.g. reduced mortality or infection rates at national level).

The steps

Once the decision to introduce IPV has been made by the national authorities, the first step in IPV introduction will be for the GPEI, GAVI and other immunization partners to support national authorities to develop annual integrated action plans for strengthening immunization services in the countries that need it most. Details will be elaborated and a model workplan with milestones and deadlines finalized by the end of 2013. Within this framework, focus will be on the following four areas:

Programme management - including use of accountability frameworks, data management, evidence-based planning, training and supply management;
Microplanning - including population mapping, harmonization of routine immunization microplans with polio SIA microplans to enable more complete session planning, vaccine supply management and cold-chain logistics;
Advocacy and communication - including top-level advocacy, engagement of local community leaders and household-level outreach.
Immunization delivery - monitoring of immunization sessions, local community coverage and vaccine acceptance, social mobilization efforts, availability of health workers, vaccine delivery and other immunization session logistics and overall quality and impact of services.

Scheduling

Schedule options

SAGE will make its final recommendation on the immunization schedule for IPV in November 2013 on the basis of available evidence. A detailed review of that evidence in June 2013 showed that the optimal timing for administering 1 dose of IPV in a routine immunization schedule in low and middle income countries is when the third dose of Diphtheria-tetanus-pertussis (DTP3) is given.

Number of doses

In countries with a 6, 10, and 14-week immunization schedule, this would mean that IPV would be administered at 14 weeks of age. For countries with a 2, 3, and 4-month schedule, the IPV dose would be administered at 4 months of age. In most cases IPV will be administered during the same visit as the third dose of OPV. For children starting the DTP schedule late (age >3 months), the IPV dose should be administered with the first DTP dose. National recommending bodies are responsible for evaluating country needs and in some cases, they may wish to follow an alternative schedule (e.g. go directly to an IPV-only schedule).

Presentation options

Currently, IPV is prequalified by WHO as a stand-alone vaccine in 1-dose, 2-dose and 10-dose presentations. WHO expects a 5-dose presentation to be available in 2014.

These products are preserved with 2 phenoxy-ethanol. This means that any open vials of this vaccine must be discarded at the end of the immunization session or six hours after opening, whichever comes first. These vaccines are licensed for use as a 0.5 ml dose administered intramuscularly.

IPV-containing combination presentations with diphtheria, tetanus, acellular pertussis, hepatitis B, or Hib antigens in tetravalent, pentavalent, or hexavalent formulations are also available but at substantially higher cost. A combination product with whole-cell pertussis is not currently available.

Financing

Cost

Discussions on prices are underway with manufacturers, but have not yet been finalized. Final price will be impacted by a number of variables including the number of doses per vial.

The current IPV-containing combination vaccines, which use an acellular pertussis component, are substantially more expensive (currently priced at US$20-40/dose).

The current IPV-containing combination vaccines, which use an acellular pertussis component, are substantially more expensive (currently priced at US$20-40/dose).

Future cost expectations

Achieving an IPV price substantially below US$ 1.00 per dose will require new products or delivery methods to be licensed. Possible options include the administration of a fractional dose (i.e. 1/5th of a full dose of IPV) through the intradermal (ID) route, or the intramuscular administration of a new IPV product containing a lower level of antigen with an adjuvant to enhance immune response. While one product may soon be licensed for intradermal administration, the adjuvanted products are unlikely to be licensed and accessible before 2015-2018.

The current IPV-containing combination vaccines, which use an acellular pertussis component, are substantially more expensive (currently priced at US$20-40/dose).

The development of an IPV-containing combination vaccine with whole-cell pertussis, which would be affordable for low and middle income country markets and could replace the currently used pentavalent (DTP-Hep B-Hib) vaccine, is not expected before 2020.

Financial support

Fast-track financial support will be available to all countries introducing IPV that can demonstrate a need. The streamlined process for obtaining financial support will be developed by end-2013.

GAVI-eligible and GAVI-graduating countries will likely receive support through the GAVI Alliance, pending a final Board decision, in a process similar to that followed for other new vaccines introduction support. Financing mechanisms for non-GAVI countries are being explored. More information on this will be available towards the end of 2013.

To establish a comprehensive global financing and supply strategy for fast-track IPV, introduction partners will need country-specific IPV introduction plans and timelines by the end of 2014 at the latest.

Routine immunization strengthening

Support for routine immunization strengthening will concentrate on key countries where it will have the most impact.

Planning is based on national context and priorities. Comprehensive multi-year plans (cMYPs) and annual plans will guide interventions. Annual national immunization coverage improvement plans are currently being developed in at least five of the focus countries.

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