Moscow, March 10, 2022. The first series of vaccines – 53,000 doses - has been produced at the plant of the Russian biopharmaceutical company “Nanolek” in the Kirov region. As part of Sanofi vaccine production localization efforts, there are plans to produce up to 3.5 million doses annually.
An agreement on setting up a domestic production of vaccines for the prevention of meningococcal infection between Nanolek and Sanofi was signed at the Biotechmed forum in Gelendzhik in 2021. At the beginning of 2022, the first stage of technology transfer was completed and Nanolek was registered as a secondary packaging company with release control. The next stage will be the transition to aseptic bottling and other steps necessary to ensure the launch of production of finished dosage forms.
It is planned that 2.2-3.5 million doses will be produced per year — this quantity will be enough to entirely meet the need of Russian healthcare for a vaccine for children of the first years of life for the prevention of meningococcal infection caused by pathogens of four of the most common serogroups of meningocci (A, C, W, Y).
This step corresponds to the Global Roadmap to achieve the meningitis targets launched by the World Health Organization on September 28, 2021. The authors of the project found out that the creation of new vaccines and support for vaccine prevention worldwide will help eliminate the epidemic of bacterial meningitis by 2030. Vaccination against meningitis will protect adults and children from the infection that annually affects five million people and kills about 290 thousand lives worldwide. At the same time, a third of the recovered still have severe complications such as hearing loss, memory problems, and mental impairment.[1]
Frederick Jumel, General Manager of Vaccines Eurasia Unit at Sanofi:
“I am glad that we have joined efforts with our partner Nanolek to actively develop local vaccine production. I hope that this way all Russian children will be protected from meningococcal infection. The meningococcal infection has a high fatality and high disability rate after the disease. Today, we have taken an important step towards achieving our goal - to save lives and protect children from infectious diseases.”
Vladimir Khristenko, president of Nanolek:
“At this challenging time, we need to focus on providing as much support to our citizens as possible, and taking care of their health is one of its most important components. We are glad that we are able to make our contribution by protecting Russian children from a deadly disease. We would like to thank our partner Sanof for joint work”.
About Menactra® vaccine
Menactra® is a polysaccharide conjugate vaccine for the prevention of meningococcal infections of four serogroups (A, C, Y, W) in children (from nine months), adolescents and adults that has been registered and used in Russia since 2014 (market authorization LP-002636 of September 22, 2014).[2]
Over 7 years of using the vaccine in Russia, a lot of 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 for the immunization of children and adults; since 2014, more than 1.5 million doses have been used in various territories.[4] The vaccine has been used worldwide for more than 15 years[5], and is registered in more than 70 countries.
About meningococcal infection
Children, adolescents and young adults are most often affected by meningococcal infection: these patient groups account for up to 70% of all cases. The danger of infection is that it can lead to severe generalized forms (SGFI), high mortality (10-20% of cases of SGFI) and disability after the disease (20-30% of patients who survived SGFI)[6].
The highest morbidity and mortality from SGFI is observed in children under the age of one, the incidence rates 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[7].
Given the unpredictability of changes in the epidemiology of meningococcal infection in the Russian Federation, it is considered expedient to use modern conjugated meningococcal vaccines with the widest coverage of the pathogen serogroups for vaccination.[8] Such multicomponent conjugate vaccines are highly effective and have a good safety profile, and therefore are widely used in many countries of the world[9].
Background information:
Nanolek: a modern biopharmaceutical company, founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. The company focuses on the production of import-substituting and innovative medicines, both proprietary and those co-developed with international partners. It is one of the leaders in the production of paediatric vaccines in Russia. In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and orphan diseases.
Sanofi: is an innovative global company working in the field of healthcare, driven by one purpose: to chase the miracles of science to improve people’s lives. Sanofi’s team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Sanofi develops innovating treatment options and life-saving vaccine for the protection of millions of people globally, while putting sustainability and social responsibility at the center of its ambitions.
Sanofi vaccines business unit is a world leader in the production and development of vaccines for humans. A wide variety of vaccines on the global market includes drugs for the prevention of more than fifteen viral and bacterial diseases. Every year, Sanofi produces more than one billion doses of vaccines to immunize over 500 million people worldwide. For more than 100 years of history, the mission of Sanofi’s vaccines business unit has remained unchanged and is aimed at protecting life and defending human health from infectious diseases. Mono- and combined vaccines are registered in Russia to prevent dangerous childhood and adult infections:
● diphtheria,
● tetanus,
● pertussis,
● poliomyelitis,
● haemophilic infection type b “Pentaxime®”, “Adacel®”),
● influenza (“VaxigripTetra®”),
● meningococcal infection (“Menactra®”).
Since 2017, “Pentaxime®” vaccine has been supplied for vaccination of children of the first years of life as part of the National preventive vaccination schedule.
[1] Defeating meningitis by 2030: global road map
http://apps.who.int/iris/bitstream/handle/10665/342010/9789240030145-rus.pdf (Date of application: 31.01.2022)
[2] Guidelines for medical use of Menactra® (market authorization LP-002636. Date of state registration: 22.09.2014.
[3] Perminova O. A., Romanenko V. V., Rodnikova V. Yu. and others. Epidemiology and preventive vaccination. 2020; 19(2): 70-78
Izvekova I. Ya., Namazova-Baranova L. S., Gogolev A., V. and others Epidemiology and preventive vaccination. 2018;17(6):19-34
[4] Headway Company report (2015-2021)https://www.hwcompany.ru/presscenter (as of February 1, 2022).
[5] Food and drug administration (FDA). Vaccines Licensed for Use in the United States
https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states (as of January 1, 2022)
[6] 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
[7] 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 of Consumer Rights Protection and Human Welfare, 2021. 256 p.
[8] SanPiN 3.3686-21 “Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases”
[9] Vaccines, 7th ed. / [edited by] Stanley A. Plotkin, Walter A. Orenstein, Paul A. Offit. Philadelphia, PA: Elsevier, 2018