The Sabin-IPV Project is a partnership between the World Health Organization (WHO) and the National Institute of Public Health and the Environment (RIVM). The project started in October 2008; its goal is to develop a process for the production of a safe Inactivated Polio Vaccine (Sabin-IPV). Even though the current (Salk) IPV could continue to be successfully used following OPV cessation; a Sabin-IPV, using the attenuated strains from the oral vaccine as seed, is preferred. The main reason is biosecurity; following OPV cessation the containment of wild-type polioviruses, from which Salk-IPV is produced, should be ensured. Further, the Sabin-IPV vaccine under-development is expected to be more affordable then the current Salk-IPV.
The National Institute of Public Health and the Environment is establishing In-House a production process for Sabin-IPV, and related test methods, based on the current RIVM Salk-IPV production technology. The process is suitable for the generation of clinical trial materials, scale-up and technology transfer to vaccine manufacturers meeting WHO predefined criteria in low and middle–income countries.
The process development and production of clinical lots takes place in RIVM's state-of-the-art facilities (Bilthoven) according to current GMP-guidelines. The product will meet, where appropriate, European release criteria for Salk-IPV and will follow the WHO recommendations for the production and control of inactivated polio vaccine.
NEWS:
Currently, the WHO/Global Polio Eradication Initiative (GPEI) is looking for new Expressions of Interest from private or public sector vaccine manufacturers in low- and middle-income countries. These manufacturers should be interested in collaborating with WHO and the RIVM in the development, manufacture and distribution of a safe effective and affordable Sabin Inactivated Polio Vaccine (sIPV).
Last year, through a similar procedure the two first potential partners were selected. The transfer of technology at their sites is expected to start in 2011. Future partners will receive the existing Sabin-IPV production process and related QC testing and are encouraged to participate in further optimization of the actual process in order to make the vaccine more affordable.
We would like to inform you that a call for an Expression of Interest (EOI) related to Sabin-IPV is now on the Global Polio Eradication Initiative (GPEI) website:
http://www.polioeradication.org/Mediaroom/Newsstories/Newsstories2011/tabid/408/iid/127/Default.aspx
If you are interested please submit your Expression Of Interest to WHO through e-mail and courier by 31 August 2011 at the latest (for procedure see attachment on GPEI website).