aunching of Russian Vaccines in Latin America

12 April 2019

GMP News

MECHNIKOV Institute, created as part of the Russian and Nicaraguan project in Managua, has begun production of commercial batches of influenza vaccine

MECHNIKOV Institute has launched the production of commercial vaccine batches in Managua (Nicaragua). The launch of the production lines was attended by the advisor for investments of the Government of Nicaragua Laureano Ortega, Deputy Minister of Health of the Russian Federation Sergey Kraevoy, President of the Nicaraguan Institute of Social Insurance Dr. Roberto Lopez, Head of Federal medical and biological agency of Russia (FMBA) Viktor Uiba and Director of the Saint-Petersburg scientific research institute of vaccines and serums of the FMBA of Russia (SPbSRIVS) Viktor Trukhin. The project has been implemented pursuant to the Instruction of Vladimir Putin, the President of the Russian Federation.

MECHNIKOV Institute has become a new stage of the collaboration of Russia with Latin American countries and a new brand with Russian participation in Central America opening the window of opportunities to improve the health care level in the whole region. The project has been implemented in close cooperation and with the support of the Pan American Health Organization (PAHO). As Director of the Saint-Petersburg Scientific Research Institute of Vaccines and Sera of Federal Medical and Biological Agency of Russia (SPbSRIVS), Viktor Trukhin said that by 2020 they are planning to complete the transfer to Nicaragua of another drug, Tuberculin.

Sergey Kraevoy noted that the facilities of the MECHNIKOV Institute allow producing up to 300 thousand doses of influenza vaccine per day during two-shift work.

Vaccine production in Managua has been established 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 construction of the production building of MECHNIKOV Institute was completed in less than a year, in October 2016. It took more than two years to fit out the production facility with modern equipment and complete the procedures for qualifying premises, critical engineering systems, validating technological processes, as part of the technology transfer process, and also validating transportation of the finished product in the cold chain conditions from Russia to Nicaragua and from Nicaragua to Cuba. In 2018, the company underwent certification for compliance with GMPrequirements, which was conducted by the Cuban CECMED center, which has the highest (fourth) level in terms of the PAHO qualification.

Not less important and time-consuming process, carried out during this period, was the registration of the Russian vaccine for the prevention of influenza in Cuba and Nicaragua with the subsequent delivery of the drug and use as part of vaccination of the population of these countries.

Government investments in construction and equipment of the Institute MECHNIKOV amounted to USD 33.5 mln, and 34% of the amount were the expenditures of the Nicaraguan party.

MECHNIKOV Institute equipment alone costs more than USD 18 mln. The managing company of the MECHNIKOV Institute is a Nicaraguan one, the Russian party represented by SPbSRIVS FMBA of Russia holds a share in its capital.

Production of the influenza vaccine is very important for the Latin American countries. At present, the deficit of the influenza vaccine 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 Columbia – 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 Basin (LAC) exceeds USD 96 bln. In total, the aggregate market of these countries, with a population exceeding 600 million people, is about 8% of the global pharmaceutical market. The growth dynamics is about 12% annually, which exceeds the indicators of the Russian market.

All the largest manufacturers of influenza vaccines are represented in the markets of Latin America, in particular, the French Sanofi Pasteur, the British GSK and the South Korean Green Cross, as well as local manufacturers of Brazil, Mexico and Argentina.

Today, the MECHNIKOV Institute is the only biotechnological facility in Central America and has the status of a regional manufacturer.

Considering that the social support of the population in the countries of the Latin American region is high, the public health sector in most countries of the region is interested in long-term cooperation based on the procurement of a sufficient number of drugs at fixed prices. MECHNIKOV Institute plans to sell its products, in particular, the influenza vaccine, at a competitive price, which will be determined depending on the volume of supply and the terms of contracts to be concluded.

MECHNIKOV Institute is a prime example of successful international cooperation, in which one has already become interested in Ecuador and Venezuela. This experience attracts attention not only from Latin American countries and companies: On March 29, 2019, the management of the largest pharmaceutical company in Ethiopia, Addis Pharmaceutical Factory, visited the production site of Institute MECHNIKOV. Unique technological solutions used in the construction of the Russian and Nicaraguan enterprise were presented to the guests from Ethiopia by the specialists of the Indian company Fabtech, who acted as a partner and general contractor in the construction of a plant of the MECHNIKOV Institute in Nicaragua.

In the future, it is planned to transfer production technologies and other immunobiological drugs to the site of MECHNIKOV Institute.

The head of the FMBA of Russia, Vladimir Uiba, notes that the development of MECHNIKOV Institute will proceed in three areas. First of all, this is the production of a vaccine for the prevention of influenza and the expansion of its sales markets. Also, MECHNIKOV Institute will provide technology transfer for production of topical drugs for the region, in particular, for Hepatitis

A vaccine and recombinant erythropoietin, the development of another institute of the FMBA of Russia – the National Research Institute for High Purity Biologicals. Another area of development will be researched in various areas, as well as training and vocational guidance among young people, in particular, in the framework of the BioNica project.




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