22 July / 2019
FORT LLC is a joint enterprise between Nacimbio of Rostec State Corporation and Marathon Group has begun manufacturing of Ultrix Quadri, a quadrivalent flu vaccine. The innovative vaccine for adults had been successfully registered by the Ministry of Health of the Russian Federation. The new vaccine will enter the market in August.
The split inactivated next-generation vaccine Ultrix Quadri includes both types of virus A (A(H1N1), A(H3N2)) and both lineages of virus B (B/Yamagata and B/Victoria) in comparison to a trivalent vaccine that includes only three types of viruses: both types of virus A (A(H1N1), A(H3N2)) and one current lineage of virus B. Following with World Health Organization recommendations, Ultrix Quadri contains 15 μg of haemagglutinin (antigen) from each strain in a single dose – 60 μg of antigen in total. The vaccine is safe, significantly reduces the risk of infection, and elicits a strong immunity, what was approved by clinical trials in which a high concentration of antibodies of each type of flu virus included in the vaccine was discovered.
"It's the first Russian vaccine with such composition which complies with every WHO recommendation and global pharmaceutical trends. It does not contain any preservatives, adjuvants or immunomodulators. The vaccine will enter the market in August 2019 and will be available for the vaccination of adults from 18 years old as a part of the national immunization program. In the future Ultrix Quadri is intended to become a mass vaccine and will replace previous-generation vaccines," said Sergey Chemezov, CEO of State Corporation Rostec.
Ultrix Quadri is produced by FORT at GMP-certified plant in Ryazan region on a full- cycle basis. In the long term period company plans to increase annual output up to 50 million doses for sale in both domestic and foreign markets. The vaccine will be released in pre-filled syringes.
"Both the trivalent Ultrix vaccine and the new quadrivalent vaccine are manufactured from the stage of antigen on a full-cycle basis in Russia. This is the key difference between our vaccine and its equivalents. We are pleased we can offer the Russian healthcare system a high-tech new generation product for the vaccination of our citizens, and we will continue to expand the range of vaccines available for Russians for the prevention of various diseases," said Alexander Vinokurov, President of the Marathon Group.
The development of Ultrix Quadri vaccine began in 2017, since WHO had recommended quadrivalent vaccines for worldwide use. Quadrivalent vaccines protect more effectively against infection because they protect from the risk associated with the simultaneous circulation of both of influenza B virus lineages. At the present time, around 70% of Flu vaccines used in the US are quadrivalent, whereas in Japan it is 100%.