The World Health Organization (WHO) included one more influenza vaccine produced at the facilities of the Saint Petersburg Institute of Vaccines and Serums (SPbSRIVS) FMBA of Russia and Instituto Latinoamericano de Biotecnología MECHNIKOV in the Republic of Nicaragua in the list of pharmaceutical products which have successfully passed the prequalification process.
The prequalification status has been obtained by Inactivated Split Influenza Vaccine (ISIV). Like the “FLU-M” vaccine, which obtained prequalification status in January 2025, ISIV is a trivalent influenza vaccine, and its strain composition is updated according to WHO recommendations for the current epidemic season.
The intermediate product (vaccine bulk) of ISIV is produced at the facilities of FSUE SPbSRIVS FMBA of Russia and then is shipped to Nicaragua where at the facilities of Instituto MECHNIKOV final production stages - quality control, filling and packaging – take place. ISIV is widely used not only in the Republic of Nicaragua but also has marketing authorizations аnd is supplied to the Republic of Cuba, El Salvador, the Republic of Guatemala, Dominican Republic and Venezuela. The obtained prequalification status will give the opportunity to expand the sales geography of the vaccine.
As with the previously prequalified “FLU-M” vaccine, ISIV has successfully passed all stages of the WHO experts evaluation process: from the review of vaccine dossier, examination of quality, safety and efficacy of the produced batches to the inspections of the production sites.
As a reminder, in January, 2025 the “FLU-M” influenza vaccine produced at the facilities of the Saint Petersburg Institute of Vaccines and Serums (SPbSRIVS) FMBA of Russia and Instituto Latinoamericano de Biotecnología MECHNIKOV in the Republic of Nicaragua obtained prequalification status and became the first Russian influenza vaccine recognized by WHO and recommended for purchase by UN agencies such as the Pan American Health Organization (PAHO) Revolving Fund and the United Nations Children's Fund (UNICEF).
