Abstract

A total of 105 countries have introduced IPV as of September 2016 of which 85 have procured the vaccine through UNICEF. The Global Eradication and Endgame Strategic Plan 2013-2018 called for the rapid introduction of at least one dose of IPV into routine immunization schedules in 126 all OPV-using countries by the end of 2015. At the time of initiating the procurement process, demand was estimated based on global modeling rather than individual country indications. In its capacity as procurement agency for the Global Polio Eradication Initiative and Gavi, the Vaccine Alliance, UNICEF set out to secure access to IPV supply for around 100 countries. Based on offers received, sufficient supply was awarded to two manufacturers to meet projected routine requirements. However, due to technical issues scaling up vaccine production and an unforecasted demand for IPV use in campaigns to interrupt wild polio virus and to control type 2 vaccine derived polio virus outbreaks, IPV supplies are severely constrained. Activities to stretch supplies and to suppress demand have been ongoing since 2014, including delaying IPV introduction in countries where risks of type 2 reintroduction are lower, implementing the multi-dose vial policy, and encouraging the use of fractional dose delivered intradermally. Despite these efforts, there is still insufficient IPV supply to meet demand. The impact of the supply situation on IPV introduction timelines in countries are the focus of this article, and based on lessons learned with the IPV introductions, it is recommended for future health programs with accelerated scale up of programs, to take a cautious approach on supply commitments, putting in place clear allocation criteria in case of shortages or delays and establishing a communication strategy vis a vis beneficiaries.

Highlights

  • In May 2013 the World Health Assembly endorsed the new Polio Eradication and Endgame Strategic Plan 2013– 2018 [1], which under objective 2 calls for all countries to strengthen routine immunization programs and replace trivalent oral poliovirus vaccine (OPV) with bivalent OPV by 2016

  • To minimize the risks associated with oral poliovirus vaccine type 2 (OPV2) withdrawal, the Strategic Advisory Group of Experts on Immunization (SAGE) had already recommended [2] the introduction of ≥1 dose of inactivated poliovirus vaccine (IPV) into all routine immunization programs in November 2012 and indicated its intent to review progress, including toward the availability of affordable IPV products

  • The results were disappointing to the manufacturers, the tender did provide some useful information around IPV pricing and manufacturing capacity for future IPV use, with price indications between $2.00 and $5.70 per dose [5], and indications that supply was sufficient to meet demand

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Summary

The Journal of Infectious Diseases SUPPLEMENT ARTICLE

In its capacity as procurement agency for the Global Polio Eradication Initiative and Gavi, the Vaccine Alliance, UNICEF set out to secure access to IPV supply for around 100 countries. Activities to stretch supplies and to suppress demand have been ongoing since 2014, including delaying IPV introduction in countries where risks of type 2 reintroduction are lower, implementing the multi-dose vial policy, and encouraging the use of fractional dose delivered intradermally. These countries had either IPV-only schedules (a full 3-dose IPV schedule) or used IPV as part of a sequential OPV/IPV schedule, and generally administered IPV in a combination vaccine This meant that 126 “OPVonly” countries would be required to introduce IPV within 17 months from the reconfirmation by SAGE in April 2014 to meet the PEEPS timeline. To meet the GPEI timelines, IPV introductions would have to be much faster (Figure 1)

PROJECTING DEMAND AND SECURING SUPPLY WITHOUT CONFIRMED DEMAND
MATERIALIZATION OF DEMAND FOR IPV
LESSONS LEARNED
Challenges of Scaling Up Vaccine Production
Establishing Allocation Criteria From the Onset Based on Programmatic
Findings
Could Be Altered by Vaccine Availability
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