Biopharmaceutical company Petrovax Pharm informs about the label extension of Grippol® Quadrivalent, a Russian 4-valent influenza vaccine, to include influenza prevention in children aged 6-17 years.
The appropriate label update was approved by the Ministry of Health of the Russian Federation1.
The age extension of Grippol® Quadrivalent was authorized on the back of the data from clinical trials conducted by lead specialized medical centers . The trials have demonstrated the vaccine’s high safety and efficacy profiles pursuant to the Russian State Pharmacopoeia’s criteria for inactivated influenza vaccines.
Grippol® Quadrivalent is the first Russian 4-valent influenza vaccine. It has been developed by Petrovax Pharm and was launched to the market by the same company in 2018 . The vaccine provides for maximum protection against four flu virus strains, namely two influenza A viruses (H1N1 and H3N2) and two influenza B lineages (B/Yamagata + B/Victoria). It is the most advanced of the current flu vaccines.
Grippol® Quadrivalent was developed using an antigen-saving technology. It contains three times less antigens as compared to other vaccines, which boosts its safety while providing for the same efficacy. Such an effect is due to Azoximer bromide adjuvant that was made a vaccine ingredient boosting vaccination immune responses. Influenza vaccines based on adjuvant technologies as also used in other countries such as the USA, Canada, and EU states. Aluminum and phosphate adjuvants are parts of a variety of anti-infective vaccines worldwide, e.g. monophosphoryl lipid was approved as a human papillomavirus vaccine adjuvant. An adjuvant technology has been used for 20+ years in manufacturing trivalent influenza vaccines Grippol and Grippol plus. Overall, these vaccines were used for immunization of about 400 million people in Russia and other countries (Belarus, Kazakhstan, Kyrgyzstan, Turkmenistan, Uzbekistan, and Iran).
NPO Petrovax Pharm has a multiyear experience in the development and production of efficacious polymer-subunit influenza vaccines of Grippol family. The development and market launch (2018) of a quadrivalent vaccine is a follow-up of the company’s R&D efforts and a strategical step in rolling out state-of-the-art immunobiologicals in accordance with WHO guidelines.
 ФГБУ «НИИ гриппа им. А.А. Смородинцева» Минздрава России, ФГБОУВО «Пермский государственный медицинский университет имени академика Е.А. Вагнера» Минздрава России, Муниципальное автономное учреждение «Детская городская клиническая больница № 11» (г. Екатеринбург).
 Решение о государственной регистрации № ЛП-004951 от 23.07.2018