Ministry of Health of the Russian Federation granted marketing authorization for a new tetravalent influenza vaccine manufactured by the Saint-Petersburg Scientific Research Institute of Vaccines and Serums of the FMBA of Russia.
On August 4th, the Ministry of Health of the Russian Federation granted a marketing authorization for Flu-M Tetra tetravalent influenza vaccine. The Saint-Petersburg Scientific Research Institute of Vaccines and Serums of the FMBA of Russia has developed and manufactures the vaccine according to the full-cycle technology. The clinical trials of Flu-M Tetra engaged more than 500 volunteers aged from 18 to 60. The vaccine indications will be extended and it will be used to vaccinate children and elderly patients already in the next year. Flu-M Tetra showed better immunogenicity than the reference product. The new vaccine forms the immunity against four existing influenza virus strains in accordance with the WHO recommendations.
“The registration of a new tetravalent influenza vaccine is a very important achievement of the Saint-Petersburg Scientific Research Institute of Vaccines and Serums of the FMBA of Russia. The clinical trials demonstrated the high quality of the vaccine, and next year it is expected to extend its indications to ensure its administration to children at the age of 6-17 and people over the age of 60. The Institute has very broad opportunities in the field of influenza vaccine production, and there is no doubt that this production will help to protect our citizens against influenza during the period of seasonal diseases, which is particularly important amidst the pandemic of new coronavirus infection,” Veronika Skvortsova, the Head of the FMBA of Russia, said.
Flu-M vaccines are manufactured according to the original technology, which, among other things, ensures less content of chicken protein as compared to the foreign equivalents, which is particularly important for allergic people.
According to the Saint-Petersburg Scientific Research Institute of Vaccines and Serums of the FMBA of Russia, Flu-M Tetra will be offered for supply within the framework of the National Calendar of Preventive Vaccinations this autumn. The Institute’s manufacturing capacities in Krasnoe Selo are able to produce approximately 20 mn doses of tetravalent vaccine per year. The enterprise plans to enhance its capacities up to 40 mn doses by the next season.
It should be reminded that the World Health Organization emphasizes the importance of influenza prevention amidst the continuing outbreak of the new coronavirus infection. During the 2020-2021 epidemiological season, less than 60% of Russian population underwent influenza vaccination.
The Federal State Unitary Enterprise “The Saint Petersburg Scientific Research Institute of Vaccines and Serums and the Enterprise for the Production of Bacterial Preparations” of Federal Medical and Biologic Agency (SPbSRIVS FMBA) has been a leading national manufacturer and the only exporter of influenza vaccines in the Russian Federation since 2015.