The current influenza strain antigen for vaccines of the 2019-2020 season, timely manufactured by SPbSRIVS FMBA for the WHO system (GISRS), was used by the essential laboratory (NIBSC) to produce the standard antigen and was assigned the reference number 19/154. This testifies to the high quality of the SPbSRIVS products that meet both international and WHO reference standards. The state-of-the-art technologies, corporate culture, highly qualified personnel and well-balanced management decisions have also contributed to the breakthrough of the enterprise in St. Petersburg.
From July 2019 onwards, the world's largest manufacturers will use the antigen produced by SPbSRIVS to control the quality of influenza vaccines as well as for research purposes in WHO laboratories and centers globally. Importantly, the now-reference antigen by SPbSRIVS will enable timely vaccination all over the world, despite the WHO’s suspended recommendation for the strain of this particular serotype and overall troublesome preparation for the upcoming epidemic season 2019-2020. Influenza remains one of the most burning issues of modern public health, and amounts to the top 10 threats of 2019 according to experts of the World Health Organization (WHO). Seasonal vaccines are used to prevent influenza annually.
As the manufacturer of influenza vaccines of the Flu-M brand, SPbSRIVS is the Russia’s only influenza vaccine producer to be a member of the IFPMA IVS working group. This status allowed the company to assist the World Health Organization during the global outbreak last spring. Because influenza virus is highly mutable, it is necessary to update the strain composition of the vaccine annually by including the most relevant viruses from the epidemic point of view. Thus, twice a year – one for the Northern and the other for Southern hemisphere – experts from around the world gather to analyze the latest data and, if necessary, adjust the strain composition of vaccines for the next epidemic season. These efforts (such as virus activity monitoring, strain shedding and profiling, selection of the most relevant components) are made within the framework of the international GISRS system supervised by WHO. Announcement of vaccine strains is followed by production of the standards for vaccine quality control, which is entrusted to essential regulatory laboratories (ERLs) within the WHO system (GISRS), such as the Institute for Biological Standardization and Control (NIBSC) in London. Note that during the preparations for the 2019-2020 season the WHO experts withheld the recommendation for the H3N2 component of seasonal influenza vaccines for as long as a month, thus forcing the manufacturers to work under pressure to meet the deadlines for the vaccination campaign.
