As part of prequalification procedure, two independent laboratories of the WHO confirmed the high quality of the vaccine for the prevention of influenza «Flu-M» and the full compliance of its parameters with international standards. The assessment was carried out according to the WHO requirements for the influenza vaccine which are exposed in “The recommendations for the production and control of influenza vaccine (inactivated)”.
The influenza vaccines produced by the Saint Petersburg Institute of Vaccines and Serums of the FMBA of Russia (SPbSRIVS) fully comply with the recommendations of WHO, they are non-adjuvanted inactivated split vaccines that contain 15 μg of hemagglutinin of each strain. «Our own technology for the production of vaccines from the strain to the finished product allows us to achieve high-quality purification of antigens, in which the content of ovalbumin (the main allergen of chicken eggs) is in the range of 1-2 ng per dose, which is a thousand times less than the permissible rates», - said Veronika Skvortsova, head of the FMBA of Russia.
As it is indicated in the official letter of the WHO Chief Technology Officer «WHO testing results confirm the acceptance of the seasonal influenza vaccine Flu-M® produced by the FSUE SPbSRIVS FMBA, Russian Federation, for prequalification».
«The high quality of vaccines produced by SPbSRIVS has been already confirmed two times by the independent WHO laboratories. The SPbSRIVS products meet all the international standards which are also demanded abroad. «Flu-M» is the second vaccine of our institute approved for the prequalification», - commented the director of SPbSRIVS, Victor Trukhin.
We recall that SPbSRIVS is the only manufacturer of full-finish influenza vaccines that supplies their products to foreign countries from 2016. The quality and safety of St. Petersburg vaccines were confirmed by WHO independent laboratories in 2021 and 2023. The vaccines of the SPbSRIVS are authorized to be marketed and are applied in 17 countries including EAEU countries and far abroad countries: Guatemala, Cuba, Nicaragua, El Salvador, Venezuela, and Dominican Republic among others. The production of the Flu-M® vaccine is certified by GMP inspections from the Russian Federation, Iran, and Cuba, moreover, the certificate of compliance to HALAL requirements of the vaccine was received in 2022.
