Sanofi and Nanolek announced successful Completion of Phase 1 of supply of the Pentaxim® vaccine manufactured by the Nanolek plant under a two-year state contract (for 2019-2020). In total, 3.5 million doses of the vaccine were delivered in 2019 - this helped protect about one million children from five dangerous infections: tetanus, pertussis, diphtheria, poliomyelitis, and Hemophilus influenza type b. It is expected that a total of about seven million doses is expected to be delivered by the end of 2020.

In May 2019, the Russian Ministry of Health, for the first time, concluded a two-year state contract for the supply of the Pentaxim® vaccine for the needs of the National Vaccination Schedule. This decision of the government customer to determine the long-term need for vaccines allowed Sanofi and Nanolek to plan for vaccine production volumes considering the duration of its production cycle (up to 12 months), as well as to ensure timely and regular vaccine deliveries.

Further concluding long-term state contracts will allow both the state customer and business to optimally organize the planning, production, logistics, and immunization mechanisms so that all Russian children could be protected from dangerous infections in a timely manner.

Multicomponent vaccines are a modern and essential tool to increase vaccination coverage, as well as the timeliness of NVS implementation. The long-term partnership between Sanofi and Nanolek intensifies the protection of Russian children from severe infectious diseases.

Guillaume Oshalter, General Manager, Sanofi Pasteur Russia, and Belarus, noted: “Vaccination is the only reliable method to avoid many serious contagious diseases, as well as subsequent complications. Nowadays, vaccination is carried out for kids around the world, which annually saves about three million children’s lives. Reducing vaccination coverage leads to the return of infections that seemed already completely defeated. To improve the situation, it is necessary, in particular, to work on the development of Russian pharmaceutical production and vaccination policies, including ensuring greater availability of drugs to as many Russians as possible. For more than four years, Sanofi and Nanolek have been jointly contributing to the fight against infectious diseases, and a lot has been done over this time. We are pleased that our partnership is developing, and thanks to it, more and more Russian children are protected against infections with modern, high-quality, and safe vaccines.”

Vladimir Khristenko, President of Nanolek, comments: “The use of combined vaccines, in particular, those containing an inactivated polio component (IPV), will make it possible to save on the prevented costs of diseases significantly. Besides, switching from monovaccines to combined ones can significantly reduce the indirect cost of vaccination. Cooperation with Sanofi helps us to introduce the most advanced vaccine production technologies in the Russian Federation and to use more effective vaccination schemes in Russia that are consistent with WHO recommendations.”

An agreement between Nanolek and Sanofi on the production of a five-component combined vaccine for children in Russia was signed in May 2015 at the Economic Forum in St. Petersburg with the participation of the Minister of Industry and Trade of the Russian Federation, the Governor of the Kirov Region and the Chairman of the Board of RUSNANO.

In 2016, the first stage of localization of vaccine production in Russia was completed, and the transfer of the vaccine quality control system was carried out. From 2016 up to the present, the company has produced five million doses of vaccine. Since 2017, the vaccine has been successfully supplied as part of the National Schedule of Preventive Vaccinations.

The use of combined vaccines can decrease the number of injections, particularly for children in their first two years of living, as well as the costs of administration, storage, and turnover of immunobiological medical drugs, while increasing vaccination coverage.

About Pentaxim® Vaccine

·       Pentaxim vaccine® designed to prevent five infections - diphtheria, tetanus, pertussis, poliomyelitis, and infections caused by Haemophilus influenza type b.

·       Pentaxim ®, for the first time, was registered in 1997 in Sweden. In domestic health practice, the vaccine has been used since 2008.

·       Pentaxim vaccine ® dosing regimen corresponds to the National Schedule of Vaccinations: vaccination is carried out at the age of 3, 4.5, and 6 months; revaccination - at 18 months. In this case, the use of the Pentaxim Vaccine® does not violate the timing of immunization against other infections in the framework of the National Vaccination Schedule.

·       Application experience in Russia and numerous clinical studies[1]conducted by leading medical institutions of the country (SSC Institute of Immunology FMBA, Research Institute for Children’s Infections FMBA, Scientific Centre for Children’s Health RAMS) have proved the high efficiency and safety of the drug in healthy children and children with differences in health status (e.g., neurological, allergic diseases, immunodeficiencies of different genesis, and born prematurely).

·       Produced by NANOLEK since 2017, Pentaxim vaccine ® has been supplied for the needs of the National Preventive Vaccination Schedule.

About Sanofi

Sanofi is a global biopharmaceutical company whose mission is to provide support to those who face various health problems.

With the help of our vaccines, we strive to protect people from diseases, and our drugs help to ease the course of many diseases and improve the quality of life for patients with rare and common chronic diseases.

Over 100,000 Sanofi employees in 100 countries around the world work every day to turn scientific innovation into particular healthcare solutions.

About Sanofi Pasteur

Sanofi Pasteur - a division of the Sanofi Group of Companies - is a world leader in the production and development of human vaccines. A wide variety of vaccines on the global market includes drugs for the prevention of more than fifteen viral and bacterial diseases. Every year, the company produces more than one billion doses of vaccines to immunize over 500 million people worldwide. For more than 100 years of history, the company’s mission has remained unchanged and is aimed at protecting life and defending human health from infectious diseases. Every day, Sanofi Pasteur invests in research and development of more than one million euros.

The following vaccines have been registered in Russia: mono - and combined vaccines for the prevention of dangerous children and adult infections - diphtheria, tetanus, pertussis, poliomyelitis, hemophilic infection type b (Imovax Polio®, Pentaxim®, Adasel), influenza (Vaxigrip), viral hepatitis A (Avaxim 160, Avaxim 80 ), and meningococcal infection (Menactra).

About Nanolek

Nanolek is a modern fast-growing Russian biopharmaceutical company with its own high-tech full-cycle production according to GMP standards, which specializes in the production of import-substituting and innovative drugs, both of its own design and is created with the engagement of international partners, with a focus on the prevention and treatment of socially meaningful diseases. Today, the company is one of the leaders in the production of paediatric vaccines in the Russian Federation.

The diversified product portfolio of Nanolek preparations is presented in the following therapeutic areas: vaccines, drugs for HIV treatment, cancer, etc. The company has unique knowledge in the field of technology transfer in partnerships with leading global pharmaceutical companies (e.g., Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.).



[1] D.A. Novikova, L.S. Namazova-Baranova, A.G. Gayvoronskaya, M.I. Broeva, M.V. Fedoseenko “Safety Assessment of the Use of Pentavacine in Premature Infants: Experience of the Centre for Family Vaccine Prevention”, Issues of Modern Pediatrics /2015/Volume 14/No. 3