October 4, 2021. The agreement on domestic production of Menactra® vaccines to prevent meningococcal infection was signed at the Biotechmed forum in the city of Gelendzhik. The ceremony was attended by Denis Manturov, the Minister of Industry and Trade of the Russian Federation, and Mikhail Murashko, the Minister of Health of the Russian Federation.

The next stage is the transfer of quality control procedures and packaging processes for the Menactra® vaccine and the signing of an addendum on the conditions for aseptic filling and other steps to localize the production of vaccines, including the production of finished dosage forms.

Menactra® will be manufactured at the innovative Nanolek plant in the Kirov Region. According to the production plan, the first batches will be released in 2022. The plant is expected to produce 2.2-3.5 million doses per year. This volume would be enough to completely satisfy the needs of Russian healthcare for a vaccine in the prevention of meningococcal infection caused by pathogens of the four most common serogroups at a time: A, C, W, Y.

These efforts are in line with the Global Roadmap to achieve the meningitis targets launched by the World Health Organization in September 28, 2021. The project authors figured out that new vaccines and vaccine prevention support measures worldwide would help eliminate the outbreaks of bacterial meningitis by 2030. Vaccination against meningitis will protect adults and children fr om the infection that annually affects five million people and claims about 290 thousand lives worldwide. At the same time, a third of those who recovered still have severe complications such as hearing loss, memory problems, and mental impairment[1].

Domestic production of Menactra® is a crucial step forward in the collaboration between Sanofi Pasteur and Nanolek. Both companies are united by one common goal - protecting the Russian citizens, especially children, from vaccine-preventable infections. The localization of the five-component vaccine Pentaxim® by Sanofi Pasteur at the Nanolek plant in the Kirov Region is set to be completed as early as in 2022. Since 2017, the vaccine has been supplied as part of the National Vaccination Schedule.

Denis Manturov, Minister of Industry and Trade of the Russian Federation:

Course for localization of advanced unique foreign products that we have set when the Pharma-2020 Strategy was developed, has proven to be effective. We still welcome and support cooperation between Russian and foreign companies in projects to set up production of medicines in Russia. It is important to note that consistent measures to extend localization will ensure the transfer of new competencies, launch of new advanced production facilities and, eventually, will make the vaccine against meningococcal infection more affordable.”

Frederic Jumel, General Manager at Sanofi Pasteur Eurasia:

“Meningococcal infection is associated with a high mortality rate and in many cases leads to disability and serious consequences. The epidemiological situation with respect to meningococcal infection in Russia is unpredictable; therefore, as many children as possible must be reliably protected against it. Sanofi Pasteur has taken another step towards this goal. We are currently expecting an increase in production, which can mainly be related to the outlook for adding meningococcal infection vaccines to the National Vaccination Schedule”.

Vladimir Khristenko, President of NANOLEK LLC:

“We are glad to take such an important step in the development of our partnership with Sanofi Pasteur, which allows us to use the latest vaccine production technologies in Russia. It is a great honour for us to work together in protecting children from dangerous infectious diseases.”

Background Information

About Menactra® vaccine

Menactra® - a polysaccharide conjugate vaccine for the prevention of meningococcal infections of four serogroups (A, C, Y, W) in children (nine months and older), adolescents and adults has been registered and used in Russia since 2014 (Registration Certificate LP-002636 of September 22, 2014)[2].

Over seven years wh ere the vaccine was used in Russia, much experience has been accumulated, and local data have been collected on its high immunogenicity and favourable safety profile in children, adolescents, and adults.[3]

According to the Headway Company report (2015–2021), Menactra® is supplied to 85 regions of the country to immunize children and adults; since 2014, more than 1.5 million doses have been used in various regions.[4] The vaccine has been used worldwide for over 15 years[5] now, registered in more than 70 countries. More than 100 million doses have been produced so far[6].

About Meningococcal Infection

The meningococcal infection is most common in children, adolescents, and young adults, and up to 70% of cases account for these age groups. Besides, the meningococcal infection leads to the severe generalized forms of infection (SGFI), high mortality (10-20% of SGFI cases) and a significant number of cases of disability after the disease (20-30% of those who suffered SGFI)[7].

The highest morbidity and mortality from SGFI is observed in children under the age of one. The incidence of MI in children from 0 to 4 years old exceed those in adults by about 25 times, even with timely diagnosis and the use of intensive, comprehensive treatment.[8].

Given the unpredictability of changes in the epidemiology of meningococcal infection in the Russian Federation, it is advisable to use modern conjugated meningococcal vaccines with the broadest coverage of serogroup pathogen for vaccination9. Such multicomponent conjugate vaccines are highly effective and have a good safety profile, therefore are widely used in many countries[9].

About Sanofi Pasteur

Sanofi Pasteur, the division of the Sanofi Group, is a world leader in human vaccine production and development. Sanofi Pasteur offers an extensive range of vaccines in the global market that includes drugs preventing against more than 15 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 more than one million euros in research and development. Mono- and combined vaccines are registered in Russia to prevent dangerous childhood and adult infections: diphtheria, tetanus, pertussis, poliomyelitis, haemophilic infection type b (Pentaxim®, Adasel®), influenza (Vaxigrip®), viral hepatitis A (Avaxim 160®, Avaxim 80®), meningococcal infections (Menactra®).

About Nanolek

Nanolek was founded by Vladimir Khristenko and Mikhail Nekrasov back in 2011. It specializes in the production of import-substituting and innovative medicines, both of its own design and those developed in cooperation with international partners. Nanolek is one of the leaders in the production of paediatric vaccines in the Russian Federation. A total of 20 medicines are now in the Nanolek’s portfolio. And 35 more are at various stages of preparation for release and will hit the market in the next five years. The Nanolek plant in the Kirov Region, which was set up in 2014, was built with an eye on the world’s best practices and technologies. The production facility holds a GMP certificate and regularly undergoes quality audits performed by large international pharmaceutical corporations: the Nanolek plant produces pharmaceuticals in cooperation with companies such as Sanofi.

About Sanofi

Sanofi is a global biopharmaceutical company whose mission is to provide support to those who face various health problems. With 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 of both patients with rare and common chronic diseases.

More than 100,000 Sanofi employees in 100 countries work every day to turn scientific innovation into specific healthcare solutions.

[1] Defeating meningitis by 2030: a global road map http://apps.who.int/iris/bitstream/handle/10665/342010/9789240030145-rus.pd (Date of the application: 29.09.2021)

[2]Instructions for the medical use of Menactra® vaccines (Registration Certificate LP-002636 date of state registration - 22.09.2014, date of amendments to the registration certificate – August 12, 2020

[3] O. A. Perminova, V. V. Romanenko, V. Y. Rodnikova and others. Epidemiology and preventive vaccination. 2020; 19(2): 70-78

I. Ya. Izvekova, L. S. Namazova-Baranova, А. V.  Gogolev and others. Epidemiology and preventive vaccination. 2018; 17(6):19-34

[4] Headway Company report (2015-2021) https://www.hwcompany.ru/presscenter (as of March 1, 2021)

[5] Food and drug administration (FDA). Vaccines, Blood, and Biologics: January 14, 2005 approval letter. http://wayback.archive-it.org/7993/20170723032519/ https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm131181.htm (as of 01.03.2020)

[6] Sanofi Pasteur. Focus on meningitis 2019. https://www.sanofipasteur.com/en/media-room/focus-on-diseases/meningitis/ (as of 01.03.2020)

[7] Sadarangani M, Pollard AJ. Clin Microbiol Infect 2016; 11:S103-S112

Pace D, Pollard AJ. Vaccine 2012; 30(Suppl. 2): B3-B9

Sadarangani M, Pollard AJ. Neisseria meningitidis (meningococcus). In: Kliegman RM, editor. Nelson textbook of pediatrics. 20th ed. Philadelphia: Elsevier; 2016. p. 1356-1365

[8]On the state of sanitary and epidemiological well-being of the population in the Russian Federation in 2020: State Report. М.: Federal Service for Supervision on Consumer Rights Protection and Human Well-being, 2021. 256 p.

9 SanPiN 3.3686-21 “Sanitary-epidemiological requirements in the prevention of infection diseases“

[9] Vaccines, 7th ed. / [edited by] Stanley A. Plotkin, Walter A. Orenstein, Paul A. Offit. Philadelphia, PA: Elsevier, 2018