Petrovax Pharm receives a license from the Russian Ministry of Industry and Trade for production of meningococcal vaccine

Biopharmaceutical company Petrovax Pharm has received a license from the Ministry of Industry and Trade of the Russian Federation for the production of a meningococcal vaccine. The disease remains one of the most dangerous among vaccine-preventable infections, with a case fatality rate that can reach up to 20%⁠^[1]. Local production of the vaccine represents an important step toward launching routine immunization in line with the Strategy for the Development of Immunoprophylaxis of Infectious Diseases in the Russian Federation.

Following an inspection, the Ministry of Industry and Trade expanded Petrovax Pharm’s manufacturing license and confirmed that the meningococcal vaccine produced by the company complies with EAEU GMP standards.

Obtaining the license marks another milestone in the vaccine localization project at the company’s facility in the Moscow Region, which was launched in 2022. Total investments in the project have exceeded RUB 3 billion.

At present, a new quadrivalent conjugate polysaccharide vaccine against meningococcal infection caused by serogroups A, C, Y, and W-135 is at the registration stage. Marketing authorization is expected in summer 2026. Petrovax Pharm’s production capacity allows for the manufacture of over 3.5 million vaccine doses per year.

The modern Petrovax Pharm manufacturing complex operates in accordance with EAEU and EU GMP standards. The facility performs pharmaceutical substance synthesis and manufactures sterile and non-sterile medicinal products in various dosage forms. The company became the first in Russia to obtain an EU GMP certificate in 2012 and successfully passed a re-audit by the Slovak State Institute for Drug Control (SIDC) in November 2025.

Background Information

The meningococcal quadrivalent conjugate vaccine containing the polysaccharides from serogroups A, C, Y and W-135 was registered in China in 2021 and has successfully completed Phase III clinical trials. Studies are currently ongoing to support registration in other countries, including Russia, Indonesia, and India, involving more than 5,000 participants. In December 2025, a Phase III clinical trial of the meningococcal vaccine was completed in Russia.

Meningitis^[2] is a severe disease with high mortality that can lead to serious long-term complications. Meningococcal infection is one of the most common causes of the most dangerous form of bacterial meningitis: approximately one in ten patients dies, and one in five develops severe complications. The disease can be fatal within 24 hours and requires immediate medical attention. Young children, adolescents, young adults, and immunocompromised individuals are at the highest risk.