Thursday, January 12, 2012
Safe, effective and affordable Sabin IPV
As part of efforts to prepare for the polio post-eradication era, the World Health Organization (WHO) and its partners have facilitated the development of a new polio vaccine technology and will start soon the transfer of this technology to vaccine production facilities in China and India.
In collaboration with the National Institute for Public Health and the Environment (RIVM) in the Netherlands, clinical lots of inactivated polio vaccine (IPV) produced from Sabin poliovirus seed-strains have been prepared. Traditional IPV is manufactured using wild poliovirus seed-strains, and in such a case a biocontainment failure could lead to serious consequences in some areas of the world in the post-eradication era (i.e. areas with high population density, inadequate sanitation infrastructure and low population immunity levels). Therefore, the use of Sabin seed-strains for IPV has the advantage over wild polioviruses that they are attenuated, and hence are safer for handling and IPV production in developing country settings.
This new technology will now be transferred to China National Biotec Group (CNBG) and Serum Institute of India, which have confirmed its intention to use all efforts to apply for registration of their Sabin IPV product within four years. These transfers are part of a broader intended technology transfer programme, which already was initiated earlier last year by the selection of the first two manufacturers in India (Panacea Biotec, Ltd) and the Republic of Korea (LG Life Sciences). WHO and RIVM will continue the technology transfer programme with further manufacturers.
This transfer of technology is a significant milestone in preparations for the polio post-eradication era. Following the eradication of wild poliovirus globally, use of all oral polio vaccine (OPV) in routine immunization programmes will need to be stopped due to the risks associated with the continued administration, in the post-eradication era, of the live (attenuated, but not inactivated) polioviruses contained in OPV. These risks include vaccine-associated paralytic polio and the generation of new, circulating vaccine-derived polioviruses. Therefore, after the eradication of all wild polioviruses, and the eventual cessation of OPV for use in routine immunization programmes, any country choosing to continue to immunize its population against polio will need to do so with IPV, the only option which will be available to do so at that time.
Recognizing that the manufacturing costs and price of IPV are currently substantially higher than that for OPV, the Global Polio Eradication Initiative is studying a range of approaches to establish affordable strategies for IPV use in low-income settings following OPV cessation. The development, manufacture and distribution of a safe, effective and affordable Sabin IPV that can be produced securely in developing country settings is a key landmark in this programme of work. This technology transfer will also help to boost more broadly the domestic production capacity for vaccines and strengthening public health systems to ensure more equitable access to vaccines.
The development of Sabin IPV and the related technology transfer preparations have been generously supported by the Bill & Melinda Gates Foundation.