Abstract
The Polio Eradication and Endgame Strategic Plan 2013-2018 calls for the phased withdrawal of OPV, beginning with the globally synchronized cessation of tOPV by mid 2016. From a global vaccine supply management perspective, the strategy provided two key challenges; (1) the planned cessation of a high volume vaccine market; and (2) the uncertainty of demand leading and timeline as total vaccine requirements were contingent on epidemiology. The withdrawal of trivalent OPV provided a number of useful lessons that could be applied for the final OPV cessation. If carefully planned for and based on a close collaboration between programme partners and manufacturers, the cessation of a supply market can be undertaken with a successful outcome for both parties. As financial risks to manufacturers increase even further with OPV cessation, early engagement from the cessation planning phase and consideration of production lead times will be critical to ensure sufficient supply throughout to achieve programmatic objectives. As the GPEI will need to rely on residual stocks including with manufacturers through to the last campaign to achieve its objectives, the GPEI should consider to decide on and communicate a suitable mechanism for co-sharing of financial risks or other financial arrangement for the outer years.
Highlights
In May 2008, in line with guidance from the Strategic Advisory Group of Experts on Immunisation (SAGE), the World Health Assembly endorsed the principle of synchronized oral poliovirus vaccine (OPV) cessation globally
Recognizing that wild poliovirus type 2 was eradicated in 1999 and that >90% of circulating vaccine-derived poliovirus cases in recent years were caused by the vaccine-derived type 2 strain, in 2012 the SAGE further recommended the withdrawal of type 2 OPV (OPV2) as the first step toward complete withdrawal of all OPVs, the final date to be confirmed in October 2015 based on progress against predefined prerequisites
Another reason could be that while OPV2 would no longer be required after trivalent OPV (tOPV) cessation, except for monovalent OPV2 for outbreak control, bulk types 1 and 3 OPV would still be required, and no major shifts were required from vaccine manufacturers, because the production, filling, packaging, testing, and releasing of bivalent OPV (bOPV) continued at the same high level of resource requirements
Summary
In May 2008, in line with guidance from the Strategic Advisory Group of Experts on Immunisation (SAGE), the World Health Assembly endorsed the principle of synchronized oral poliovirus vaccine (OPV) cessation globally. In 2013, the Global Polio Eradication Initiative (GPEI) published the Polio Eradication and Endgame Strategic Plan 2013–2018 [2], which called for the phased withdrawal of OPV beginning with the globally synchronized cessation of use of OPV2 by mid 2016 [2, p 58, section 6.20], and final withdrawal in 2019–2020 [2, p 60]. From a global vaccine supply perspective, the strategy provided 2 key challenges; (1) the planned global synchronized cessation of a high-volume vaccine market and (2) the uncertainty of demand leading up to cessation, given that the timeline and total vaccine requirements were contingent on epidemiological circumstances. Owing to the high annual volume of OPV, the workload to vaccine manufacturers—bulk production, filling, testing, packaging, and releasing—is extremely high, and changes in demand, including the prospects of market cessation, have considerable implications for manufacturers’ resource allocations (eg, staff, investment planning, and maintenance), and such changes need to be planned for well in advance
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