Ensuring sufficient vaccine supply – the example of OPV In 2013, vaccine procurement reached a value of nearly $1.3 billion. This translates into 2.8 billion doses for children in 100 countries, including the supply of oral polio vaccine (OPV) to 76 countries. In terms of the number of doses procured, OPV exceeded other vaccines at 1.7 billion doses.
Time frames to consider in OPV procurement
Complexities in OPV supply chain
In 1999, WHO and governments took the decision to accelerate polio eradication activities and conduct multiple national immunization days per year targeting all children under the age of five. This strategic decision nearly quadrupled demand for OPV from 650 million to 2.1 billion doses. The scale of activities was constrained to fit with the actual quantity of vaccine made available given the long lead times for producing polio vaccines (approximately 20 months). Since then, UNICEF and WHO have provided long-term forecasts and have worked closely with industry to ensure sufficient production capacity. In addition, a rigorous process of monitoring demand and provisioning supply was put in place.
While polio vaccine has been on the market for decades, demand became more acute after the Global Polio Eradication Initiative (GPEI) was launched in 1988.
Before OPV is procured, it is essential to know: the OPV type required, that funding is available and when vaccines need to be delivered.
OPV formulations targeting specific strains of WPV were critical to the success in stopping polio in Egypt, India and other countries.
UNICEF and partners work with governments to identify and consolidate numbers on country needs. Accurate forecasts build confidence into a system reliant on suppliers to produce sufficient quantities within specified time frames.
In 2013, GPEI enters its endgame phase of eradication, which requires the phasing out of OPV and the introduction of one dose of Inactivated Polio Vaccine (IPV). This strategy will reduce and eventually eliminate the risk of vaccine-derived polio outbreaks.
Definition of need Manufacturers need a 20 month lead time to produce OPV. from scratch (or from “bulk”). When bulk is already available, lead times for finished products may be as low as three months. A healthy market will always include buffer stock to meet unplanned needs.
6 Supply Annual Report 2013
In recent years, demand and supply have become more complex to manage because of the use of different OPVs that target specific strains of wild poliovirus (WPV). The availability of these targeted OPVs, combined with immunization campaigns, has resulted in the decline of the number of polio-endemic countries from 125, at the start of the global polio eradication efforts in 1988. Today there are three countries where WPV has not been stopped: Afghanistan, Nigeria and Pakistan. The supply chain illustration below shows the different variables as they occur either within individual segments or where segments interface, and includes a process-bound timeline that underscores the complexity of OPV procurement, monitoring and delivery.
UNICEF and partners hold annual consultations with partners and industry to ensure a common understanding of programmatic challenges and needs, and agree on strategies to support production planning, and financing and procurement approaches, that make vaccines more affordable.
Budgeting & planning In addition, UNICEF Supply Division meets on a quarterly basis with programme partners to discuss adjustments that must be made as a result of changes in programme priorities and epidemiology.
OPV is available in different formulations and presentations (number of doses per vial). In 2013, UNICEF procured trivalent OPV (tOPV) which targets all three strains of poliovirus, bivalent OPV (bOPV) which targets types 1 and 3, and monovalent OPV, UNICEF uses longer-term, multi-year tenders and awards to give a wider planning horizon and more certainty to manufacturers.
All vaccines procured by UNICEF are prequalified by WHO. Prequalification certifies that vaccines meet international standards for quality and safety. Some countries also have a National Regulatory Agency (NRA) which requires local licensing of vaccines.
Contracts are awarded to multiple suppliers for each product. At the time of making awards, UNICEF assesses the prequalification pipeline and decides if quantities should be left un-awarded - to provide incentives to new suppliers.
Procurement
Suppliers take a minimum of 4-6 weeks to fulfil a purchase order. This time is needed to pack vaccines and have them ready for air shipment.
Delivery & clearance
Some countries require pre-delivery inspections of vaccines, and paper work prepared in advance of shipments arriving at the port of entry.