Inactivated Polio Vaccine (IPV) Frequently Asked Questions March 2014

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1. When did GAVI start supporting inactivated polio vaccine (IPV)?

In November 2013, the GAVI Board decided to open a funding window such that the GAVI Alliance can invite GAVI-eligible and GAVI-graduating countries to submit proposals for support to introduce one dose of inactivated polio vaccine (IPV) into their routine immunisation programmes by the end of 2015, in line with the Polio Eradication and Endgame Strategic Plan (Endgame Plan) 2013-2018.

The Endgame Plan was developed following the May 2012 declaration by the World Health Assembly of the completion of poliovirus eradication to be a programmatic emergency for global public health and called for an endgame strategy. The plan outlines a comprehensive approach for completing eradication, including strategic objective 2, which calls for the introduction of IPV in all OPV-only using countries by the end of 2015. The primary role of IPV will be to maintain immunity against type 2 poliovirus, while withdrawing type 2 containing OPV globally. A key component of this objective is the strengthening of routine immunisation systems, as high immunisation coverage is essential to achieving the goals of the polio endgame and long-term sustainability of polio eradication efforts.

Recognising the Global Polio Eradication Initiative’s (GPEI) responsibility for eradicating polio, GAVI’s overall objective related to polio eradication is to improve immunisation services in accordance with GAVI’s mission and goals while supporting eradication by harnessing the complementary strengths of GAVI and GPEI in support of countries.

More information on the Endgame Plan and GPEI can be found here.

Countries can consult the application information and resources available on the GAVI website at: http://www.gavialliance.org/support/apply/.

2. Is our country eligible to apply for GAVI support for IPV?

GAVI-eligible and GAVI-graduating countries are eligible for IPV support. 1 Please see Annex A for the full list of countries eligible to apply for IPV through GAVI. There is no requirement for a minimum national DTP3 coverage level prior to application. Countries currently eligible for GAVI support that cross the eligibility threshold while the IPV application window is still open will continue to be eligible for IPV support.2

1 Note: Support for IPV introduction in India would be considered separately by the GAVI Board and therefore not in the scope of these guidelines. Ukraine has already introduced IPV. 2 The policy exceptions will be reconsidered by the GAVI Board in 2018.

3. What kind of GAVI support can a country receive to introduce IPV?

Countries can receive GAVI support to introduce IPV in the following ways:

 Vaccine and supplies: GAVI-eligible and GAVI-graduating countries may receive IPV support based on a one-dose vaccination schedule, as well as associated supplies (auto-disable syringes and waste disposal boxes).  Vaccine introduction grant (VIG): Countries approved for IPV introduction will also receive a one-time cash grant to support a share of the additional costs related to the new vaccine introduction, with any remainder necessary, being funded by the government or partners.  Technical Assistance (TA): Countries can request assistance with planning for IPV implementation through WHO and UNICEF.

Co-financing: GAVI has made a policy exception for IPV to its usual co-financing requirement due to the unique needs of polio eradication. Therefore, countries are not required to co-finance IPV. Countries are encouraged to contribute to vaccine and/or supply costs if they are able to. If a country is in default on the co-financing requirement for other vaccines, it is still eligible to apply for IPV.3

4. What is the application process for IPV support?

When applying for IPV, the IPV application guidelines should be reviewed and the following documents must be submitted:

 IPV Introduction Plan (Guidance provided in Annex A and WHO’s new vaccine introduction plan template4)  IPV Application Form (Annex B)  IPV Introduction timeline of activities (Annex C)  VIG and Operational Cost Detail Template (Annex D)

All application materials can be found on GAVI’s website at: http://www.gavialliance.org/support/apply/

The completed application must be submitted electronically to the GAVI Secretariat at: [email protected]. Please see Section 2 of the IPV Support Guidelines (p. 8) for a complete checklist of mandatory items to be submitted with the application.

3 These policy exceptions will be reconsidered by the GAVI Board in 2018. 4 Further information available at: http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_resources/nvi_guidelines/en/ 2

The following table details the application submission timelines for 2014 for IPV introduction.

Vaccine Introduction Application due date IRC meeting date Decision letter Grant disbursed 6 February 27 February – 7 March 30 March 28 – 30 April Within four weeks Within six weeks of of end of IRC issuing the decision 1 May 23 June – 4 July letter 15 September 10 – 21 November

5. Which IPV presentations will be available with GAVI support?

Two different product presentations are available through UNICEF with GAVI support for countries planning to introduce in 2014:  Single-dose vial of IPV: A single dose vial of IPV is available from July in limited quantities until 2016 when supply could increase.  Ten-dose vial of IPV: The majority of available supply in this and coming years will be in a 10 dose vial presentation.

A five- dose vial presentation is also expected to become WHO prequalified and available for supply towards the end of Q3/early Q4 2014 but quantities will be less than the 10 dose vial. From 2016 the supply of the five-dose vial will increase considerably with the ability to meet demand from all countries, should the need arise.i

While countries should indicate their first preferred product presentation, countries should also include a second and a third preferred presentation in their application to GAVI in order to facilitate early introduction in all countries. Countries will be allowed to switch when their preferred product presentation becomes available in sufficient quantity.

For information on the current IPV supply and recent tender results, please visit: http://www.unicef.org/supply/index_66260.html

For information on the IPV prices and suppliers, please visit: http://www.unicef.org/supply/files/IPV.pdf

For information on the single-dose vial of IPV, please visit: http://www.who.int/immunization_standards/vaccine_quality/pq_231_ipv_1dose_nvi/en/

For information on the ten-dose vial of IPV, please visit: http://www.who.int/immunization_standards/vaccine_quality/PQ_99_ipv_10_dose_sanofi_pasteur/en/

For information on the vaccines procured by UNICEF with GAVI funding, please visit: http://www.unicef.org/supply/files/Product_Menu_March_2014.pdf

6. Can a country applying to GAVI choose an IPV containing hexavalent vaccine (pentavalent and IPV) rather than standalone IPV?

GAVI only purchases WHO prequalified vaccines and currently, there are no prequalified combination vaccines that contain IPV.

The current IPV-containing combination vaccines contain an acellular pertussis component, and are available in tetravalent, pentavalent, or hexavalent formulations. These vaccines have a high price compared to the pentavalent vaccine which GAVI supports, which contains whole-cell rather than acellular pertussis. The IPV-containing combination vaccines are currently in constrained supply at the global level. An IPV-containing combination vaccine containing whole cell pertussis, which could be more affordable, is not expected before 2020.ii

7. How would GAVI support for IPV work for countries wishing to introduce more than one dose in their routine schedule?

GAVI-eligible and GAVI-graduating countries may receive IPV support based on a one dose vaccination schedule, as well as associated supplies (auto-disable syringes and waste disposal boxes). GAVI’s support for a one-dose vaccination schedule follows the November 2012 WHO Strategic Advisory Group of Experts (SAGE) on immunisation recommendation that countries add at least one dose of IPV into their routine immunisation schedules.iii

If a country chooses to introduce IPV with a multiple-dose schedule, the country would need to self-fund the additional doses and associated supplies.

8. Can IPV be introduced at the same time as another vaccine?

Countries are encouraged to find synergy for IPV introduction with existing plans for other new vaccine introductions scheduled in 2014 or 2015.

Studies conducted in Tanzania and Ghana regarding dual vaccine introductions have indicated efficiencies in both cost and time, such as combined health worker training, reprinting new vaccination cards or monitoring forms, etc. The option to undertake a joint introduction should be discussed with the Minister of Health, the National Immunisation Technical Advisory Group (NITAG), and local and regional immunisation staff as soon as possible to plan accordingly.iv

9. If a country introduces two vaccines at once, will the country receive one or two Vaccine Introduction Grants (VIGs) from GAVI?

Countries will receive a Vaccine Introduction Grant (VIG) for each eligible vaccine introduction. The VIG is a one-time cash grant to support a share of the additional costs related to the new vaccine introduction, with any remainder necessary, being funded by the government or partners. There is no reduction of the VIG in the case of joint introductions. Countries should provide details of how any potential cost savings will be utilised to support additional vaccine introduction activities. 4

10. Can a country apply to GAVI for support for IPV campaigns?

GAVI support is available for one dose of IPV provided through the routine immunisation programme. GAVI support for IPV is not available for campaigns (including catch-up campaigns). However, support could be provided for a phased national rollout for countries that are interested in introducing IPV in their routine immunisation system in parts of the country before expanding their introduction to cover the rest of the country.

11. Can a country self-procure IPV using GAVI support?

Yes, under specific circumstances. GAVI’s self-procurement policy will apply.

Further information on GAVI’s self-procurement policy can be found on GAVI’s website: http://www.gavialliance.org/about/governance/programme-policies/self-procurement-policy/

12. What if our country would like to introduce IPV by using a combination vaccine containing IPV and receive cash in lieu of the vaccine. Is that possible?

Yes, under specific circumstances. GAVI’s self-procurement policy would apply. Further information on GAVI’s self-procurement policy can be found on GAVI’s website: http://www.gavialliance.org/about/governance/programme-policies/self-procurement-policy/

Cash support would be provided for the equivalent number of doses of IPV that GAVI would provide of the vaccine, regardless of how many of doses of an-IPV containing vaccine a country may choose to administer per child. The level of funding that would be disbursed would be equivalent to the UNICEF Weighted Average Price (WAP) for IPV vaccines multiplied by the number of doses that would normally be awarded to and procured for the country.

Please refer to question 6 for additional information on combination vaccines containing IPV.

ANNEX A: List of GAVI IPV Eligible Countries

Afghanistan Lesotho Angola Liberia Armenia Madagascar Azerbaijan Malawi Bangladesh Mali Benin Mauritania Bhutan Moldova Bolivia Mongolia Burkina Faso Mozambique Burundi Myanmar Cambodia Nepal Cameroon Nicaragua Central African Republic Niger Chad Nigeria Comores Pakistan Congo Papua New Guinea Congo, DR Rwanda Côte d'Ivoire Sao Tomé & Principé Cuba Senegal Djibouti Sierra Leone Eritrea Solomon Islands Ethiopia Somalia Gambia South Sudan Georgia Sri Lanka Ghana Sudan Guinea Tajikistan Guinea Bissau Tanzania Guyana Timor-Leste Haiti Togo Honduras Uganda India5 Ukraine Indonesia Uzbekistan Kenya Viet Nam Kiribati Yemen Korea DPR Zambia Kyrgyzstan Zimbabwe Lao PDR

5 Note: Support for IPV introduction in India would be considered separately by the GAVI Board. 6

i UNICEF. Interim Update Note on the Supply of Inactivated Polio Vaccine. Available at: http://www.unicef.org/supply/files/2014_01_29_IPV_update.pdf. Accessed on 10 February 2014. ii WHO. Plan for IPV Introduction. Available at: http://www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/plan/en/index1.html Accessed on 10 February 2014. iii WHO (2014). Weekly Epidemiological Record. Meeting of the Strategic Advisory Group of Experts on immunization, November 2013. 2014: 1. iv WHO (Jan. 2014). Planning for IPV Introduction: Implementation Facts. Available at: http://www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/ipv_tech_faqs_jan2014.pdf?ua=1. Accessed on 11 February 2014.