In July 2018, Petrovax Pharm was issued Marketing Authorization No. LP-004951 of 23.07.2018 for Grippol® Quadrivalent, a 4-valent inactivated subunit adjuvanted vaccine designed for prevention of influenza. It is the most advanced flu vaccine in the world that employs an antigen sparing technology and has a high preventive activity and safety.
Grippol® Quadrivalent will be manufactured in Russia full-cycle starting from API production to the applicable GMP regulations. The vaccine will be preservative-free and will be released in single-dose syringes.
Grippol® Quadrivalent is the first in Russia 4-valent flu vaccine that offers protection against four influenza virus strains, i.e. two flu type A viruses (H1N1 and H3N2) and two type B viral cell lines (B/Yamagata + B/Victoria).
The key benefit of the Russian quadrivalent vaccine is a high efficacy with a low reactogenicity. The body antigen load is decreased due to the use of Polyoxidonium (azoximer bromide), a water-soluble, biodegradable adjuvant that enhances the immune response to vaccination and provides for cutting the antigen load three-fold as compared to traditional technologies, i.e. for using 20 µg of hemagglutinin instead of 60 µg.
This technology is unique and unprecedented on the global scale; for 20 years, it has been used to manufacture Grippol® and Grippol® plus vaccines. Their efficacy and high safety profiles have been confirmed by their multi-year use within the framework of the national immunization schedules and state immunization programs of Russia, Belarus, Kazakhstan, Kyrgyzstan, and Iran in a variety of high-risk populations, including children, pregnant women, individuals with chronic diseases, and the elderly.
The development of Grippol® Quadrivalent started in 2015. Since then, preclinical and clinical trials have been conducted as required by the applicable national and international regulations. The results of Phase I-III clinical trials (Protocol GriQv-III-16) demonstrated Grippol® Quadrivalent’s favorable safety profile and high efficacy. The vaccine conforms to the EC Committee’s for Proprietary Medicinal Products (CPMP) efficacy criteria for flu vaccines.
Until recently, flu vaccines approved in Russia contained three flu virus strains, i.e. two type A strains (H1N1, H3N2) and one type B strain. Since 2012, the WHO has recommended using quadrivalent vaccines for influenza prevention. This is due to the necessity of boosting preventive action of flu vaccines and, as a result, reducing morbidity rates, economic losses, and increasing the trust for annual vaccination among the population. According to health economics studies, in case of replacing a 3-valent vaccine for a 4-valent vaccine, the estimated number of prevented flu cases in Russia will be 265.8 thousand, with the avoided medical costs exceeding 2.5 billion RUB.
Only six countries manufacture quadrivalent vaccines on their own, including Australia, the USA, Canada, New Zealand, Germany, and France. Russia is the 7th country that has independent vaccine production capacities.
The R&D and marketing authorization efforts put into Grippol® Quadrivalent mark both a logical continuation and a significant step forward made by Petrovax Pharm in launching state-of-the-art immunobiologicals to the market. The project was implemented in line with the roadmap for the development and manufacture of state-of-the-art human immunobiological products approved by the Russian Government. It has significantly contributed to the implementation of the Federal Target Program «The Development of the Pharmaceutical and Medical Industry Until 2020 and Beyond». Petrovax Pharm places special emphasis on this project that opens new opportunity for the domestic healthcare in terms of flu prevention and the development of exports of Russian high-tech products.
 Marketing Authorization approval No. 20-2-4050821/R/RLP of 23.07.2018.
 А.В. Рудакова, С.М. Харит, А.Н. Усков, Ю.В. Лобзин, Предотвращенный ущерб при вакцинации против гриппа 3-х и 4-х валентными вакцинами, Журнал Инфектология, том 9, № 2, 2017.