Instituto MECHNIKOV has launched the production of commercial vaccine batches in Managua (Nicaragua). Minister of Health of Russia Veronika Skvortsova, President of the Nicaraguan Social Security Institute Dr. Roberto Lopez, Head of Federal Medical And Biological Agency of Russia (FMBA) Viktor Uiba and Director of the Saint Petersburg SRI of Vaccines and Serums of the FMBA (SPbSRIVS) Viktor Trukhin turned out to witness the launch of the manufacturing lines. The project has been implemented pursuant to the Instruction of Vladimir Putin, the President of the Russian Federation.
The Instituto MECHNIKOV has become a new stage of cooperation between Russia and the Latin American countries and a new Russian-invested brand in Central America, which opens up unique opportunities for enhancing the healthcare quality across the region. The project has been implemented in close cooperation and with support of the Pan American Health Organization (PAHO). According to Viktor Trukhin, Director of the Saint Petersburg SRI of Vaccines and Serums of the FMBA (SPbSRIVS), another technology transfer to Nicaragua, the one of tuberculin, is scheduled for completion in 2020.
Sergey Kraevoy noted that the capacities of the Instituto MECHNIKOV allow producing up to 300 thousand doses of influenza vaccine per day with two-shift work.
Vaccine production in Managua was launched in record-breaking time. According to UNIDO, the cycle from designing such a plant to launching production in developing countries can take up to 7 years. The production building of Instituto MECHNIKOV was built in less than a year, by October 2016. It took more than two years to fit the facility with modern equipment and complete the qualification procedures for premises, critical engineering systems, validation of technological processes, as part of the technology transfer, as well as validation of the finished product transportation through the “cold chain” from Russia to Nicaragua and from Nicaragua to Cuba. In 2018, the company was certified for compliance with GMP requirements by the Cuban center CECMED, ranked the highest (fourth) level as per the PAHO qualification.
As much important, demanding and time-consuming procedure, accomplished during this period, was the regulatory approval of the Russian influenza vaccine in Cuba and Nicaragua, enabling the product delivery for vaccination of the population in those countries.
Government investments in construction and equipment of the Instituto MECHNIKOV amounted to 33.5 million USD, of which 34% were invested by the Nicaraguan party. The cost of equipment for the Instituto MECHNIKOV alone exceeded 18 million USD. The Instituto MECHNIKOV is managed by a Nicaraguan company, with the Russian party being represented by SPbSRIVS FMBA as a shareholder.
The influenza vaccine production is vital for the Latin American countries. At present, the influenza vaccine deficit in the region is up to 100 million doses annually, and, considering the plans to raise the level of influenza vaccination of the population to 30% by 2022, the deficit will be increasing. Based on the PAHO/WHO data, influenza and pneumonia cause 4.6% of all deaths in Nicaragua. In Brazil – 8.12%, in Colombia – 4.2%, in Mexico – 3.97%, and in Cuba – 7.14%.
The market of pharmaceutical and immunobiological drugs of the countries of Latin America and the Caribbean (LAC) exceeds 96 billion USD. In total, these countries, with a population exceeding 600 million people, make about 8% of the global pharmaceutical market. The growth dynamics is about 12% annually, which exceeds the indicators of the Russian market.
The Latin American markets have been penetrated by all the major influenza vaccine manufacturers such as the French Sanofi Pasteur, the British GSK and the South Korean Green Cross, as well as by the local manufacturers in Brazil, Mexico and Argentina.
As of today, the Instituto MECHNIKOV is the only biotechnological enterprise in Central America and boasts its status as the regional manufacturer.
Considering the high social security for the population in Latin America, the public health sector in most countries of the region seeks long-term cooperation based on the procurement of a sufficient number of medications at fixed prices. The Instituto MECHNIKOV plans to sell its products, in particular, the influenza vaccine, at a competitive price, which will be determined depending on the volume of supplies and the terms of contracts.
The Instituto MECHNIKOV is a vivid example of successful international cooperation, which has already aroused interest in Ecuador and Venezuela. This experience attracts attention not only from Latin American countries and companies: On March 29, 2019, the management of Addis Pharmaceutical Factory, the Ethiopia’s largest medicine manufacturer, visited the production site of the Instituto MECHNIKOV. Unique technological solutions used in the construction of the Russian-Nicaraguan enterprise were presented to the Ethiopian guests by the specialists of the Indian company Fabtech that acted as a partner and general contractor in the construction of a plant of the Instituto MECHNIKOV in Nicaragua.
Other immunobiological pharmaceuticals are scheduled for the production technology transfer to the site of Instituto MECHNIKOV in the future.
The head of the FMBA of Russia, Vladimir Uiba, has outlined three avenues for the Instituto MECHNIKOV to pursue. The top priorities are the influenza vaccine production and the expansion to new markets. Besides, the Instituto MECHNIKOV will ensure production technology transfer to provide the region with vital drugs, in particular, Hepatitis A vaccine and recombinant erythropoietin, developed by another institute of the FMBA of Russia, the National Research Institute for High Purity Biologicals. Other areas of development include research in various fields, as well as training and vocational guidance for the young, in particular, within the framework of the BioNica project.
