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.
Intravacc is establishing In-House a production process for Sabin-IPV, and related test methods, based on the current Intravacc 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 clinical lots have been produced in Intravacc's state-of-the-art facilities (Bilthoven) according to current GMP-guidelines following European release criteria for Salk-IPV and the WHO recommendations for the production and control of inactivated polio vaccine. This clinical lots have been tested succesfully in both adults and infants.