“Prior to 2015, Johnson & Johnson did not have any supply chain facilities in Western Africa. For the Ebola vaccine regime, we need to start from scratch,” writes Gino Vleugels, Senior Manager, EMEA Temperature Control, Janssen (J&J’s pharma division). “This is a major undertaking with extremely tight timelines. Simultaneously many things have to occur.” Read on to find out, in Gino’s own words, how the company went about implementing this programme
Johnson & Johnson is working to quickly advance the approval and availability of safe, effective Ebola vaccines in sufficient quantities to meet global demand.
To do so, the various elements of the supply chain process needed to be created:
- The Sierra Leone Kambia District was the location selected for the warehouse (depot). It needed to be built in four weeks to be ready for inspection. This is a challenging environment with no electricity, so power was supplied by generators and the fuel was stored in guarded tanks.
- The Ebola vaccine is temperature controlled and must stay frozen through shipping and storage. This is no easy task in such a hot climate. Shipping boxes were in development and required validation. Freezers were installed at the warehouse. A Warehouse Management System had to be executed.
- Study sites (vaccination centres) needed to be prepared for clinical trials. These sites may be located in remote areas only reachable by motorbikes or 4×4 trucks. Clinical teams had to be established, and clinical protocol, standard operating procedures and instructions needed to be ready for implementation and to start dosing Sierra Leone habitants participating in the clinical trial.
- Contracts between local and international partners needed to be established, and the team worked with the Ministry of Health on import/export procedures.
Getting our new Ebola vaccine safely into Sierra Leone for clinical trials is a feat of teamwork-over-temperature. The vaccine has to be transported 5,000 miles, stored in warehouses, distributed to clinics within Sierra Leone and then administered – all without exceeding very low temperature thresholds.
Johnson & Johnson’s supply chain organisation played a key role in the success of this complicated undertaking.
The Ebola shipment really does represent supply chain excellence in execution. The vaccines have to be transported from the UK to the Kambia district in Sierra Leone, where some of the country’s most recent Ebola cases were reported. Under the leadership of the Janssen pharmaceutical team, the vaccines are transported from here to there without any temperature deviations that could damage the clinical trials.
We determined the best modes of transportation and carriers to get the vaccines to Sierra Leone, selected the location to build the storage depot in Sierra Leone, designed the storage layout, qualified the storage freezers, and selected local service providers in Sierra Leone to take care of the ‘last mile’ transport of the vaccines to clinics via SUVs and motorbikes.
During the whole trip and through all the handovers, the goods had to be kept at very specific temperatures – sometimes as low as minus 60°C. Our Quality Assurance team tracked the shipments at every step, comparing the vaccine’s temperature with our R&D stability protocol. In the end, the vaccines were approved for use in Sierra Leone.
The Sierra Leone project is a key step in J&J’s move into rapid access programmes that can deliver Ebola vaccines quickly and safely into areas where there is an outbreak of this deadly disease.
J&J is one of the leading companies working to get this terrible disease under control or even eliminate it from the world completely – and this project was a key milestone in that effort.
My upcoming presentation at FlyPharma is not showing how good we all are, but showing why we daily make these efforts – because we care about people.
This clinical trial is an excellent example of teamwork and our belief that Janssen, pharma division of Johnson & Johnson, can make the difference!
Gino Vleugels was writing ahead of his presentation at the upcoming FlyPharma Conference, taking place 7-8 June 2016 in the Sheraton Hotel, Brussels. To find out more, please visit www.flypharmaconference.com