Small investment company Invak - Nanolek LLC Joint Venture and the Federal State Budgetary Institution for Health and Social Development named after M.P. Chumakov of the RAS - applied for registration the first domestic inactivated polio vaccine (IPV). The registration of the vaccine will make it possible in the future to uninterruptedly provide citizens of the Russian Federation with a highly effective and safe vaccine, which is included in the list of the National Calendar of Preventive Vaccinations (NKPP).
The inactivated polio vaccine (IPV) on Sabin strains will be produced according to the technology developed by the Federal State Budgetary Institution of Scientific Research named after M.P. Chumakov of the RAS. The production of the finished dosage form is to take place at the NANOLEK site in the Kirov Region. The project provides for the construction of additional production facilities as part of the development of the Biopolis biotechnological immunobiological research and educational centre located in the Kirov Region. Both organizations are the participants of that centre.
The planned production capacities will fully cover the additional needs of our state for the IPV - for the full transition to the inactivated polio vaccine within the framework of the NKPP of the Russian Federation and deliveries to the EAEU and other foreign markets within the context of cooperation with the UNICEF and WHO.
The partnership of the Federal State Budgetary Institution for Health and Social Development named after M.P. Chumakov of the RAS and Nanolek LLC - a successful example of a public-private partnership to bring promising domestic developments to the market. Implementation at the NANOLEK site of the production of the vaccine developed by the Federal State Budgetary Institution of Scientific Research named after M.P. Chumakov of the RAS was made possible thanks to the production and technological competencies acquired by NANOLEK in the process of transfer and organization of production of the finished dosage form of the IPV fr om the substance (Bilthoven Biologicals).
“It is important to note the relevance of the project not only for Russia, wh ere the annual need for IPV has been estimated at 8 million doses but also for export potential. It consists, first of all, in a drastic shortage of IPV on the international market associated with the WHO polio elimination program and the systematic transition to the use of inactivated vaccines instead of living ones. According to experts, the export potential of IPV can be up to 20 million doses per year. Our institute produces substances on the territory of Russia. It has the permission of the WHO to supply vaccines for the needs of UN agencies (UNICEF),” noted the General Director of the Federal Scientific Research and Design Institute named after Chumakov Aidar Ishmukhametov.
According to the Central Research Institute of Epidemiology of Rospotrebnadzor, 95% of the population is required to prevent the occurrence of epidemics of dangerous diseases. The problem was also identified in Presidential Decree No. 97 of March 11, 2019, which approved the Fundamentals of the state policy of the Russian Federation in the field of ensuring a chemical and biological safety until 2025 and for the future. The primary biological threats are the absence of specific immunity in the population to individual infections controlled by preventive measures, i.e., vaccinations.
“In the current epidemiological situation, the WHO European Region recommends that each country take all possible measures to maintain a high level of population immunity. Prioritise primary vaccine complexes, especially when it comes to vaccines containing measles and rubella or polio components and other combined vaccines. We, at NANOLEK, see this as our primary task - to meet the needs of the Ministry of Health of Russia with effective, safe, and high-quality vaccines, the production of which is organised in the Russian Federation”, said the Executive Director of NANOLEK Maxim Stetsyuk.
“MIP Invak can become a new model of cooperation, which will fully allow implementing the scientific potential of domestic research centres in partnership with proven vaccine manufacturers and the necessary experience on the most modern international quality standards,” said Yuri Tikhonovich Kalinin, President of the Rosmedprom Association, chairman of the RUIE Commission for the pharmaceutical and medical industries.
The IPV is the first project of MIP Invak. It is being implemented as part of the country’s development of immunobiological safety and the transition to the production of full-cycle vaccines. It is planned that at the end of 2020, the production of the finished dosage form will begin with the release of the substance in 2023. The plans of the Invak enterprise include the full-cycle production of other vaccines for immunization of the population of the Russian Federation under the NKPP, taking into account its future needs.
Poliomyelitis
According to the World Health Organization, poliomyelitis is a threatening disease caused by the virus. It affects the nervous system and can lead to general paralysis in a matter of hours. The virus is transmitted from person to person, mainly through some common carrier of infection (for example, contaminated water or food). In one out of 200 diseases, irreversible paralysis (usually of the legs) takes place. About 5-10% of such paralysed people die due to the onset of respiratory muscle paralysis.