Fiocruz and Funed receive Anvisa's registration for meningococcal vaccine

The Institute of Technology on Immunobiologicals (Bio-Manguinhos/ Fiocruz) and the Ezequiel Dias Foundation (Funed) have just received registration from the Brazilian Health Regulatory Agency (Anvisa) for the production of the meningococcal ACWY conjugate vaccine. The registration is the result of a partnership between the two institutions and the pharmaceutical company GlaxoSmithKline (GSK), carried out in line with the Brazilian Ministry of Health (MS). The agreement provides for the nationalization of the immunizer that prevents against the four main serogroups of meningococcal meningitis and that is present in the National Vaccination Calendar for adolescents aged 11 and 12 since 2020.

Bacterial meningitis represents an important challenge in public health, in view of its significant morbimortality and sequelae rates, particularly in developing countries. Worldwide, it is estimated that there are more than one million cases annually. Three bacterial agents are among the main agents that cause the bacterial meningitis in the community: Streptococcus pneumoniae (pneumococcus), Haemophilus influenzae type b, and Neisseria meningitidis (meningococcus). The mortality rate can reach up to 70% if there is no treatment. In Brazil, between 2009 and 2021, 219,342 cases of bacterial meningitis caused by meningococcus were confirmed.

The immunization schedule of the Brazilian National Immunization Program (PNI) recommends a two-dose scheme of the meningococcal C conjugate vaccine at three and five months of age, and a booster administered at 12 months. The meningococcal ACWY conjugate vaccine is recommended for adolescents aged 11 and 12 years as a single dose. Recently, the Ministry of Health extended this indication to 13 and 14-year-old adolescents, with the aim of reducing the number of carriers of the bacteria in the nasopharynx.

The tripartite agreement and the registration offer a national solution for the production and supply of the PNI with the meningococcal ACWY conjugate vaccine. The project seeks to integrate the capabilities of Funed, which already has expertise in the meningococcal C vaccine, with GSK, owner of this technology, and Bio-Manguinhos/Fiocruz, which will enable production capacity, including of the active pharmaceutical ingredient (API), through its infrastructure and technical knowledge in the production of bacterial vaccines.

“This agreement, and now the registration, are another step in Fiocruz's strategy of technological consolidation and updating of the Bio-Manguinhos vaccine portfolio, in line with the priorities already announced by the Ministry of Health”, explains the president of Fiocruz, Mario Moreira.

The initiative is in line with the search for national self-sufficiency in the area of health, by reducing dependence on international inputs and incorporating strategic technologies for the country, strengthening the Health Economic-Industrial Complex (Ceis) of public laboratories, in addition to the Unified Health System (SUS).

“The institutional mission of Bio-Manguinhos is to contribute to the national demand for vaccines, diagnostic kits and biopharmaceuticals. This vocation makes us seek to actively participate in partnerships that may contribute to the growth and strengthening of the SUS. We are very pleased to be able to be part of this initiative in this direction”, says Mauricio Zuma, Director of Bio-Manguinhos/Fiocruz.

For the president of Funed, Felipe Attiê, the partnership with Fiocruz, an internationally renowned institution that gave rise to Funed, through Ezequiel Dias and Oswaldo Cruz, contributes to the strengthening of the Brazilian Unified Health System and, further, to the development of the institution's production capacity for biological products, especially in the field of meningitis. “Technology transfer agreements like this one, signed with a public reference laboratory like Bio-Manguinhos and with a world pharmaceutical company the size of GSK, are of great importance for Funed's growth”, emphasized Felipe.

“Vaccination is one of the main intervention strategies in public health and the National Immunization Program is a reference for Latin America and the world. GSK is privileged to have a long history of partnership with the Brazilian government. It has been more than thirty years establishing different strategic alliances for the supply of immunizers for the PNI. We are very proud to sign this partnership, expanding our contribution to the access to meningococcal meningitis prevention”, says Andre Vivan, President of GSK Brasil.

Once the registration with Anvisa is obtained, the transfer of technology moves on to the second stage of the project, in which the two national institutions will be able to carry out the labeling and packaging of the immunizers received from the transferring pharmaceutical company. At this stage, quality control is also conducted nationally. The entire transfer of technology also includes two more stages of internalization of production processes, which involve final processing, with formulation, filling and inspection, in addition to the last stage of production of the vaccine API, with the complete nationalization of the production of the immunobiological.

Funed 

Founded in 1907, the Ezequiel Dias Foundation (Funed) has been working for 115 years seeking health solutions for the strengthening of the SUS. With three areas of activity involving research, laboratory and industry, it is recognized as an important Science and Technology Institute in the state of Minas Gerais. It carries out studies in different areas of knowledge, being a reference in scientific research based on venoms from snakes, spiders, scorpions and bees. It also trains human resources for production sectors, biotechnology-based companies and science and technology institutions through its Graduate Program in Biotechnology.

Funed also houses the Central Public Health Laboratory of the State of Minas Gerais (Lacen-MG), which carries out analyses and tests for health, epidemiological, environmental and worker health surveillance, with emphasis on the work on genetic sequencing and genomic surveillance. In the industrial field of health, it is responsible for the production of drugs, such as Thalidomide and Entecavir, besides being the only public laboratory supplying the meningitis C vaccine to the Ministry of Health and one of the three Brazilian laboratories producing antivenom and antitoxic serums.

GSK

GSK is a multinational biopharmaceutical company, present in 92 countries, whose purpose is to unite science, technology and talent to overcome diseases and impact global health. The company researches, develops and manufactures vaccines and specialty drugs in the infectious disease, HIV, oncology and immunology/respiratory areas. Present in Brazil for over 110 years, it is a leader in the HIV and respiratory areas and one of the leading companies in vaccines. GSK actively contributes to Brazilian public health both by providing reference drugs for various diseases and through partnerships with national health and research institutions.

Bio-Manguinhos/ Fiocruz 

The Institute of Technology on Immunobiologicals (Bio-Manguinhos) is the Fiocruz unit responsible for research, innovation, technological development and production of vaccines, diagnostic kits and biopharmaceuticals aimed primarily at meeting the demands of the national public health. Founded in 1976, Bio-Manguinhos has an outstanding performance on the international scenario, not only by exporting its surplus production to over 70 countries, but also by exchanging experiences and information, technical-scientific events and partnerships with public and private institutions through Technology Transfer agreements, Product Development Partnerships (PDPs) and autochthonous development projects, which contribute to the expansion of its portfolio with already more than 40 products.