Created in 1900, the Oswaldo Cruz Foundation (Fiocruz) promotes health, generates scientific and technological knowledge, and acts as an agent of citizenship. Linked to the Brazilian Ministry of Health, the institution articulates social policies to a development model that aims to ensure the strengthening and consolidation of the Unified Health System (SUS), ensuring more access to health for the population. Recognized for its competence in formulating strategies, offering products, and scientific and teaching activities, Fiocruz plays a vital role in national development. All these achievements are the result of the work of almost 13 thousand professionals, committed to the constant improvement of the public health network.
Its headquarters, as well as most of its units, are in Rio de Janeiro, on an 800 thousand m² campus. However, the Foundation has regional units and representative offices in 11 Brazilian states. It also has an office in Maputo, capital of Mozambique, to articulate, monitor and evaluate the health cooperation programs developed with African countries.
Bio-Manguinhos is one of the 16 technical-scientific units of Fiocruz. In 2021, it delivered 233 million doses of vaccines to the National Immunization Program (NIP). In addition, 5.4 million vials of biopharmaceuticals and 26.5 million diagnostic reagents were supplied to other agencies of the Ministry of Health. Since 2001, with the pre-qualification of the yellow fever vaccine by the World Health Organization (WHO), it operates in the international public market through the surplus of its production for the Unified Health System (SUS) and has already supplied the vaccine to 75 countries. As a result of its portfolio of projects and technological development, Bio-Manguinhos’ portfolio consists of 57 products: 11 vaccines, 10 biopharmaceuticals, and 36 diagnostic reagent kits.
Bio-Manguinhos is an institution in constant growth and transformation. In recent years, this movement has intensified. The unit has been expanding its infrastructure and will operate a new plant in the Industrial District of Santa Cruz, in Rio de Janeiro: the Biotechnology in Health Industrial Complex (CIBS). Aiming to expand the supply of vaccines and biopharmaceuticals for public health programs, the campus will house the New Final Processing Center (NCPFI), as well as areas dedicated to quality assurance and control. The venture will increase the possibilities for partnerships for technological development and Brazil’s competitiveness in the biotechnology sector. In addition, aligned with the policy of deconcentration of technological development and the national expansion of Fiocruz, a new campus is being implemented in Ceará, located in the Polo Tecnológico Industrial da Saúde (PTIS), in the municipality of Eusébio. Bio will implement a new unit at the site, being the Institute’s first industrial plant outside the state of Rio de Janeiro. The area will be dedicated to plant-based technologies.
Since the emergence of the new coronavirus (SARS-CoV-2), Bio-Manguinhos/Fiocruz has been working to offer solutions to the Brazilian population to face the health emergency, being part of the several national and international efforts to research and produce a vaccine against Covid-19. The Foundation strives to maintain its efforts in this field, together with the Ministry of Health (MoH), reinforcing the importance of the Brazilian Unified Health System (SUS) as the support base for the development, production, and national distribution of vaccines for the disease. The main bet is an agreement with the biopharmaceutical AstraZeneca for the production, in Brazil, of the new coronavirus vaccine developed by Oxford University. The agreement predicts the delivery of doses to the National Immunization Program (NIP), part of the Brazilian Unified Health System (SUS). On March 8, 2021, the start of large-scale production of the Covid-19 vaccine was announced, and since then, regular deliveries of the immunizer have been made to the NIP.
With the signature of the technology transfer contract, it was possible for Bio-Manguinhos to start producing the Active Pharmaceutical Ingredient (IFA) entirely in Brazilian territory. In January this year, Fiocruz received a favorable report from the National Health Surveillance Agency (Anvisa) for the change in the Covid-19 (recombinant) vaccine’s registration, which requested the inclusion of the Foundation also as a producer of the Active Pharmaceutical Ingredient (IFA). After AstraZeneca’s technology transfer, and with Anvisa’s approval, the Foundation becomes the first institution in the country able to produce and distribute a 100% national Covid-19 vaccine to the Ministry of Health.