The first production of a full-cycle vaccine against meningococcal infection will be launched in Russia.

The first Russian project to localize the full production cycle of a meningococcal vaccine will be implemented in the Moscow Region. The relevant clause is contained in the cooperation agreement signed between the regional government and the Petrovax Pharm biopharmaceutical company on the sidelines of the Russia and the World: Healthy Longevity Trends forum.

In addition, the document provides for the development of entrepreneurship and innovative technologies in the Moscow region; assistance in strengthening the healthcare system and the economy of the region; exchange of experience and joint work to improve legislation. The agreement was signed by Ekaterina Zinovieva, Deputy Chairman of the Government of the Moscow Region, Minister of Investment, Industry and Science of the region, and Kirill Danishevsky, Vice President for Corporate Communications at Petrovax Pharm.

"As part of the agreement, Petrovax Pharm is implementing the first Russian project to localize the full production cycle of a meningococcal vaccine at an existing facility in Podolsk, Moscow region. The volume of investments in the project will exceed 3 billion rubles. The company's production facilities will allow it to produce more than 3 million doses of the vaccine annually," Ekaterina Zinovieva said.

According to her, the launch of the vaccine production will take place next year, the plant will provide 70 new jobs in the region. It is expected that it will fully meet the needs of the Russian market and will allow for exports abroad, including the CIS countries.

The project provides for the localization of a full cycle of a quadrivalent conjugated polysaccharide vaccine against meningococcal infection of serogroups A, C, Y and W-135. Its production in Russia will make meningococcal immunization much more affordable. It is assumed that the cost of the drug will be at least 20% lower than the already registered tetravalent conjugate polysaccharide vaccine for the prevention of meningococcal infection.

This is the first quadrivalent vaccine approved and registered in China in 2021, for use in children from 3 months to 3 years old. To date, more than 3 million people in China have already been immunized with the vaccine. Clinical studies conducted in China have shown that the vaccine has a favorable safety profile and is approved for use in pediatric practice. At the same time, research is also continuing in China on the use of the drug in adults and children: from 4 to 6 years old, from 7 to 17 years old and from 18 to 59 years old.

Currently, a clinical trial of the vaccine is underway in Russia among adults, adolescents and children, registration is expected in early 2026. In addition, the vaccine has already received a number of regulatory approvals and certifications in Indonesia, some countries in the Middle East and South America.

"Ensuring the country's infection safety is one of the most important health goals. We have extensive experience in the production of complex biological products, including vaccines, which allows us to bring new local highly demanded biotechnological drugs to the market. We hope to start full—fledged vaccination of the Russian population, including children, as early as 2026, especially given the recent increase in morbidity and mortality from meningococcal infection," Kirill Danishevsky emphasized.

Meningococcal conjugate vaccine protects against four types of meningococcal bacteria — A, C, Y, W135. It contains polysaccharides (purified bacterial shell components) of these four serogroups, as well as CRM197 protein, which is obtained from weakened diphtheria bacillus, which does not cause the disease. Together, these components train the immune system to fight meningococcus, especially in children.

This disease is especially dangerous for children, adolescents and people with weakened immune systems. Meningococcal infection can manifest itself in the form of inflammation of the nasopharynx, brain membranes and blood poisoning. Very often, the disease leads to serious consequences or even death. Bacterial meningitis is considered the most dangerous form, it can lead to death in just 24 hours, and every sixth person, according to the World Health Organization (WHO), dies after infection.

According to the Meningitis Research Foundation, about 2.3 million cases of meningitis are reported worldwide each year. In 2021, the likely number of deaths from this disease was 214,000, with almost half (43%) of all deaths occurring in children under the age of five.

In Russia, there are sporadic increases in morbidity (every 10-30 years), especially in the autumn-winter period. According to the annual report provided by the Federal Service for Supervision of Consumer Rights Protection and Human Welfare, in 2023, 611 severe cases of meningitis were registered in the country, and the mortality rate was 19%.

Meningitis is an insidious disease, and it can be extremely difficult to make a timely diagnosis. At the same time, based on a Russian retrospective multicenter study of the incidence of meningococcal infection in children aged 1 month to 18 years for the period 2012-2021, it follows that every fifth patient is admitted to the hospital only on the second day of the disease or later. At the time of hospitalization, 86% of patients have a condition ranging from severe to terminal, while hospitalization is optimal 3-6 hours after the first symptoms appear.

"Mortality in severe forms of meningococcal infection is up to 50%. And those who have recovered may have complications such as, for example, hearing loss, vision loss, neurological disorders and cognitive impairments," Jan Vlasov, Chairman of the All—Russian Union of Patients (VSP), MD, noted in an interview with Izvestia.

Also, according to Yuri Lobzin, Honorary President of the Federal Scientific and Clinical Center for Infectious Diseases of the FMBA of Russia, chief freelance specialist in infectious diseases in children of the Ministry of Health of the Russian Federation and the FMBA of Russia, Academician of the Russian Academy of Sciences, in some cases, to save a patient's life, it is necessary to resort to amputation of limbs, excision of extensive necrosis, which leads to the formation of scars and requires multiple repeated operations.

Russian and foreign doctors agree that the only effective way to combat meningococcal infection is vaccination. In 2021, WHO adopted a new strategy to combat meningitis, the roadmap is calculated until 2030. [1]Vaccination is called one of the main measures to combat the disease.

"The sooner the vaccine is introduced for wider distribution, the more likely it is that morbidity, the number of severe forms and, consequently, deaths will decrease," Sergei Voznesensky, associate professor of the Department of Infectious Diseases at the RUDN University, emphasized in a comment to RBC.

According to the Russian Strategy for the Development of the immunoprophylaxis of infectious diseases for the period up to 2035, the meningococcal vaccine is planned to be included in the National Calendar of Preventive Vaccinations (NCPP) in 2025. Despite calls from experts to include routine immunization against meningococcus in the NCPP as soon as possible, it is now included only in the Calendars of preventive vaccinations in a number of regions, and is also carried out according to epidemic indications in the foci of infection.