Nanolek: clinical testing of the inactivated vaccine for prevention of poliomyelitis is completed« Назад
The NANOLEK Company has completed the cycle of clinical testing of the inactivated vaccine for prevention of poliomyelitis (IPV). This testing was performed within the joint project with the Bilthoven Biologicals Company (Netherlands) on the setting up production of a full cycle of the inactivated vaccine for prevention of poliomyelitis (IPV).
The program of clinical testing was developed and carried out in full accordance with requirements of World Health Organization and Ministry of Health of the Russian Federation. At the first stage, in the research with participation of adult healthy volunteers, the high safety of a vaccine, shown earlier in a number of the researches conducted in Europe, was confirmed. The second stage, studying of indicators of a reactogenicity and immunogenicity of a vaccine for children, in comparison with the foreign analogue registered in the Russian Federation, confirmed safety and high immunological efficiency of the vaccine being studied.
The Bilthoven Biologicals Company has been specializing on production of vaccines since 1909. IPV vaccine of the Bilthoven Biologicals company is applied both in the countries of the European Union, and exported to other countries of the world. The joint project of the NANOLEK Company and the Bilthoven Biologicals Company on the setting up production of a full cycle of the first national IPV vaccine was declared in 2012. The total amount of partners investments in the-is project is about 100 million RUB.
The IPV vaccine is included to the National Vaccination Schedule and is considered as a strategically important medicine. This project is very important, because there was not any local production of the inactivated vaccine for prevention of poliomyelitis in Russia by now: the foreign companies medicines are purchased for vaccination. According to experts, lack of local production of the IPV vaccine constrains development of the National Vaccination Schedule regarding transition from use of a live oral vaccine to inactivated vaccine, that all developed countries of the world had already made.
The NANOLEK Company performs localization of the IPV vaccine production at the premises of its enterprise in the Kirov region in accordance with the GMP Standards and in compliance with all international requirements to the biological medicines production.