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 has successfully passed the prequalification process by the World Health Organization (WHO). This is 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).
“FLU-M” is a trivalent inactivated split vaccine without adjuvants for the prevention of influenza, which contains 15 μg of hemagglutinin of each influenza virus strain. Our own production technology allows achieving the highest level of antigen purification: the content of ovalbumin (the main allergen) is 1000 times less than in other domestic and foreign vaccines (1-2 ng/dose).
The World Health Organization prequalification status reaffirms the high quality of the vaccine, which meets international requirements and standards. This builds confidence in the vaccine and increases its accessibility, as when entering the global market, it allows the manufacturer to bypass lengthy country-by-country registration procedures or take advantage of an accelerated registration procedure.
During the prequalification activities, the vaccine underwent a thorough comprehensive examination: WHO experts assessed the vaccine dossier, analyzed the quality, safety and efficacy of the vaccine batches produced. GMP inspections were held at production facilities of SPbSRIVS FMBA of Russia and Instituto MECHNIKOV in Nicaragua in April and May 2023. As a result, a positive decision was made to include FLU-M in the list of WHO prequalified vaccines, along with such influenza vaccines as Vaxigrip (Sanofi), GC Flu (GC Biopharma), Serinflu (Abbott).
Сurrently there are only two WHO prequalified influenza vaccines in the Latin America and Caribbean Region – “FLU-M” produced by Instituto MECHNIKOV (Nicaragua) and the vaccine produced by Instituto Butantan (Brazil). This opens new opportunities for the institute, including expanded supplies through international organizations and strengthened partnerships with pharmaceutical stakeholders in the region.
The Instituto Latinoamericano de Biotecnología Mechnikov is the only immunobiological enterprise in Central America that carries out the final stages of the production of sterile immunobiological preparations. The company was established according to an agreement between Russian President, Vladimir Putin, and President of the Republic of Nicaragua, Daniel Ortega.
Instituto Mechnikov’s product line includes Influenza vaccine (split virion, inactivated) (ISIV), “FLU-M”, “FLU-M Tetra”, as well as COVID-19 vaccine “Convacell”. There are 7 new products at different stages of production in the process of technology transfer. Instituto MECHNIKOV has 21 marketing authorizations in 6 countries of the region (Nicaragua, El Salvador, Venezuela, the Dominican Republic, Cuba) and 1 emergency use authorization for “Convacell” vaccine.
Over the years of work of FMBA of Russia in the Republic of Nicaragua, SPbSRIVS and Instituto MECHNIKOV have accumulated extensive expertise in terms of authorization, promotion, technology transfer, clinical trials as well as active pharmacovigilance studies in many Latin American countries, which allows promoting Russian pharmaceutical products in the region in general and in Nicaragua in particular. Commercial shipments have now exceeded 28 000 000 doses since the establishment of the facility in 2019.
