Petrovax Pharm has launched production of Grippol® Quadrivalent, the first Russian 4-valent vaccine to prevent flu.
In 2018, Petrovax Pharm’s pharmaceutical complex in Moscow Region marked its 10th anniversary. The company has commemorated the event by manufacturing the first batches of Grippol®Quadrivalent and making a presentation of the third production line for API as well as suppository and tablet dosage forms.
Grippol® Quadrivalent, a 4-valent inactivated subunit adjuvanted vaccine, was authorized in July 2018 (Marketing Authorization No. LP-004951 of 23.07.2018). Presently, it is the most advanced flu vaccine with a high preventive activity and safety. Grippol® Quadrivalent is manufactured in Russia full-cycle starting from API production to the applicable GMP regulations; it is preservative-free and is supplied in single-shot syringes to protect 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).
Ahead of the manufacturing complex’s anniversary, Petrovax Pharm has also presented an investment project for launching the third line to produce drug substances and finished dosage forms. When implemented, the project will boost production of APIs 2.5-fold, suppositories 4-fold, and tablets 7-fold. The new line will create more than 70 new jobs. The project investment is 1 billion RUB.
About Grippol® Quadrivalent
Grippol® Quadrivalent is the first Russian 4-valent influenza vaccine; it was approved in 2018 (MA No. LP-004951 от 23.07.2018) . The vaccine protects 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). It is the most advanced flu vaccine that employs an antigen sparing technology and has a high preventive activity and safety.
The key benefit of the vaccine is a decrease of the body antigen load due to the use of Polyoxidonium (azoximer bromide), an 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 antigen sparing technology is unique; for more than 20 years, it has been used in Russia to produce vaccines that have been successfully administered within the framework of the national immunization schedules in the Russian Federation and other countries.
Only six countries manufacture quadrivalent vaccines on their own, including Australia, the USA, Canada, New Zealand, Germany, and France. Russia joined the club in 2018 with independent vaccine production capacities.
For the epidemic flu season 2018–2019, Grippol Quadrivalent will contain four viral strains as recommended by the WHO:
- A/Michigan/45/2015 (H1N1)pdm09-like virus;
- A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus;
- B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage);
- B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage).
The WHO determines the viral strains to be included both into trivalent and quadrivalent vaccines on an annual basis. Following the WHO guidelines, the fourth viral strain being added for the epidemic flu season 2018–2019 as compared to trivalent vaccines is B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage).
In the epidemic flu season 2018–2019, Grippol® Quadrivalent is indicated for adults aged 18+. Presently, clinical trials of this vaccine in children are underway as approved by the Russian Ministry of Health. The opportunity to administer the vaccine in the pediatric population in the epidemic flu season 2019–2020 will depend on the time of its complete approval by the MoH for this age group, with the appropriate amendments of the label.
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 .
 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.