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IMMUNOLOGY

Construction begins on Brazil’s new National Vaccine Center in Belo Horizonte

The institution will function as a link between basic immunobiological research and final products

CTVacinas / UFMGTechnician performing an experiment at CTVacinasCTVacinas / UFMG

A ceremony was held at Belo Horizonte Technological Park (BH-Tec), Minas Gerais, on December 19 to mark the beginning of works on a much needed institution in Brazil: the National Vaccine Center (CNVacinas). The new center is the result of a partnership between the Federal University of Minas Gerais (UFMG), Brazil’s Ministry of Science, Technology, and Innovation (MCTI), and the state of Minas Gerais. Its mission will be to develop vaccines and immunobiological products, from conception and animal testing to phase 1 human trials. If everything goes as planned, CNVacinas will fill an important gap in Brazil’s pharmaceutical innovation structure and give the country a number of capabilities that are currently available at very few public institutions.

“Brazil has an almost complete vaccine ecosystem,” says immunologist Ricardo Gazzinelli, a professor at UFMG and head of CTVacinas, the predecessor of the new center. Many universities and research institutes have staff who are well qualified and capable of designing new formulations and carrying out tests on cells and laboratory animals. There are also a number of Brazilian groups with experience in conducting phase 2 and 3 clinical trials, and the country’s pharmaceutical industry is able to produce and bottle drugs and vaccines in large quantities for the public health system, which distributes them nationwide. However, there is no bridge between these two ends of the process. “We are missing the innovation stage, which goes from proof of concept to phase 1 clinical trials. The new center will fill this niche,” explains the scientist. His research group recently completed this stage with a COVID-19 vaccine candidate called SpiN-Tec-MCTI-UFMG and began testing on human beings (see Pesquisa FAPESP issue no. 321).

The gap became more evident during the COVID-19 pandemic, when several vaccine candidates were developed by Brazilian scientists, but there were no factories in the country capable of producing pilot batches in accordance with best manufacturing practices. The Butantan Institute in São Paulo and FIOCRUZ’s Institute of Immunobiological Technology (Bio-Manguinhos) in Rio de Janeiro are two of the few centers currently able to transition from basic research into vaccines and immunobiological agents to clinical trials while following the standards required by regulatory agencies, such as ANVISA. According to Gazzinelli, however, the facilities have not been used for this purpose.

CNVacinas will be located at BH-Tec, next to the UFMG campus in the Pampulha region. The five-story, 8,700-square-meter building will include auditoriums and laboratories for developing technologies and conducting tests at different phases, as well as a quality control and prototype validation sector and a biosafety level 3 (BSL-3) laboratory for working with genetically modified organisms. There are also plans to build a pilot-batch plant with the capacity to produce 300 to 30,000 doses. The pharmaceutical industry and researchers from other institutions will be able to contract services provided by the center, which will also work on the development of immunobiological agents and diagnostic tests for human and veterinary diseases. “The center will develop the technology and then transfer it to the industry to produce on a large scale,” says the immunologist. “The idea is to help Brazil become self-sufficient in all stages of vaccine development and production,” he says.

Building and equipping the new center will cost R$80 million, funds that are already available—R$50 million from the National Fund for Scientific and Technological Development and R$30 million from the government of Minas Gerais. In December, excavators cleared the area where CNVacinas will be built. It is expected to be completed in 2025.

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