The current influenza strain antigen for the 2019-2020 vaccine season produced by FSUE SPbSRIVS FMBA of Russia promptly for the WHO system (GISRS) was used by the key laboratory (NIBSC) for manufacturing the standard antigen and received catalog number 19/154.
This indicates a high level of quality of SPbSRIVS products that meet not only the international, but the WHO reference standards, which is due to modern technologies, production culture, staff competence and management decisions of the St. Petersburg enterprise.
From July 2019, the antigen produced by SPbSRIVS will be used to control the quality of influenza vaccines by the world’s largest manufacturers, as well as for research purposes in WHO laboratories and centers around the world. It is important that now SPbSRIVS’s reference antigen will ensure timely vaccination of population around the world, despite the delay of the WHO recommendation on the strain of this serotype and generally complicated preparation for the impending 2019-2020 epidemic season.
Influenza remains one of the most pressing problems of modern public health, and it is among the top 10 threats of 2019 according to experts of the World Health Organization (WHO).
Seasonal vaccines are used for annual flu prevention. SPbSRIVS is a manufacturer of the Flu-M vaccine family and the only Russian producer of influenza vaccines that is included in the Influenza Vaccine Supply Task Force (IFPMA IVS). This status allowed the company to assist the World Health Organization in the difficult situation this spring.
We would like to remind that due to influenza variability, it is necessary to update the vaccine strain composition every year – to include the most relevant viruses from an epidemic point of view. Thus, twice a year – for each of the northern and southern hemispheres – 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.
This work – monitoring of virus activity, isolation and characterization of strains, selection of the most relevant components – is carried out as part of the international GISRS system administered by the WHO. After the announcement of vaccine strains, the next key step is the production of references for quality control of vaccines, which is entrusted to key regulatory laboratories (ERL) in the WHO system (GISRS), for example, the National Institute of Biological Standardization and Control (NIBSC) in London.
It should be noted that in preparation for the 2019-2020 season the WHO experts delayed the recommendation for the H3N2 component of seasonal influenza vaccines for a whole month, which led to the need to mobilize all resources of manufacturers for timely preparation for a vaccination campaign.