IPV safety, and price and presentation options
IPV safety information
Inactivated Polio Vaccine (IPV) was licensed in 1955 and underwent early reformulations to enhance potency and ensure safety in standalone and combination vaccines. IPV is one of the safest vaccines in humans, whether used alone or in combination vaccines. No serious adverse events have been reported. The side effects that do occur are usually mild, such as temporary redness or tenderness at the injection site.
Supply and vaccine presentation
There is enough production capacity of current IPV standalone vaccines to meet the needs for all OPV-using countries to introduce one dose of IPV into their routine immunization programme. However, to ensure sufficient IPV is available when countries are ready for its introduction, it is essential that all countries define their target introduction dates as soon as possible.
Currently, IPV is prequalified by WHO as a stand-alone vaccine in 1-dose, 2-dose and 10-dose presentations. The vast majority of supply available for 2014 and 2015 will be in 10 dose vials, starting from July 2014. There will be limited supply of 1 dose vials available from Q2 2014 to the end of 2015; however, this supply will be prioritized for countries which have already introduced the vaccine in the programme with this product presentation.
UNICEF expects a limited supply of 5 dose vials to be available from the end of 2014, pending national licensure and WHO pre-qualification, with the availability of 5 dose vials increasing from 2015 onwards. Starting in 2016, UNICEF foresees that there will be sufficient supply of 5 dose vials should all countries request this product presentation.
Application of the WHO Multi-Dose Vial Policy for IPV
In November 2014, the multi-dose vials of IPV produced by Sanofi Pasteur and Bilthoven Biologicals were approved for use for up to 28 days after opening.
The approval decision was based on new preservative efficacy data from studies conducted by Bilthoven Biologicals and Sanofi Pasteur on their IPV vaccines presented in 5 and 10 dose-vials. The data showed that both multi-dose vaccine presentations may be used up to 28 days after opening, provided that the product is appropriately handled and stored.
More information on the application of the multi-dose vial policy (MDVP) for IPV and the programmatic implications is available on the following document.
Financing for GAVI eligible and graduating countries
GAVI supported countries are eligible to receive support for IPV introduction into routine immunization programmes (based on a 1 dose vaccination schedule) and associated supplies including auto-disable syringes and waste disposal boxes. A one-time cash Vaccine Introduction Grant (VIG) is also available to GAVI eligible countries to support a share of costs related to new vaccine introduction. The VIG is calculated at $0.80 per child in the birth cohort or a lump sum of $100,000 (whichever is higher). Technical assistance in planning and preparing for IPV introduction through WHO and UNICEF is also available to all countries.
In relation to GAVI co-financing, these requirements have been waived for IPV due to the unique needs of the polio eradication timeline, however countries are encouraged to contribute to vaccine and/or supply costs. All GAVI policies related to IPV will be reviewed by the Alliance Board in 2018.
Financing for non-GAVI countries
For countries that are not eligible for GAVI support, WHO and UNICEF are committed to exploring all options to support the timely introduction of IPV.
Technical assistance is available to support these countries to develop IPV introduction plans, and to facilitate access to low cost IPV products through UNICEF-procurement processes. If necessary, time-limited financial support may be considered to help initiate procurement. For more information, contact the WHO or UNICEF country office.
|IPV pricing as of 28 February 2014|
|Ten-dose vials||Five-dose vials||Single-dose vials|
|Middle-income countries*||EUR 1.49-2.40||USD 1.90 per dose||USD 2.80 per dose|
|(approx. USD 2.04-3.28 at current exchange rates)|
*For more information on IPV pricing per type of presentation, including pricing tiers for middle-income countries, please see the following links.