The Immunobiologicals Technology Institute (Bio-Manguinhos) at Fiocruz was selected on Tuesday (9/21) by the World Health Organization (WHO) as a center for development and production of vaccines with messenger RNA technology in Latin America. The choice of the Foundation's unit occurred because of the promising advances in the technological development of an mRNA vaccine against Covid-19, currently in the preclinical stage. The initiative relied on funds from the Ministry of Health and parliamentary amendments in its development.

The selection is the result of a global call launched on April 16, 2021, which aimed to increase production capacity and broaden access to Covid-19 vaccines in the Americas. About thirty Latin American companies and scientific institutes participated.About thirty Latin American companies and scientific organizations participated. The selection process was carried out by a committee of independent experts (PDVAC). Besides Fiocruz, another proposal, located in Argentina, was also selected.

According to the WHO, Bio-Manguinhos/Fiocruz was chosen because of its long tradition in vaccine production and the advances made in developing an innovative mRNA vaccine against Covid-19. The candidate vaccine is based on self-replicating RNA technology, and contains not only the Spike protein, but also the N protein, for improved immune response. This technology has lower production requirements, achieving a larger scale in terms of doses than other mRNA vaccines. This allows its cost to be lower than other similar vaccines, making it possible to increase access to it. The vaccine is currently in the pre-clinical trial phase.

Once developed, the candidate vaccine will go through the WHO prequalification process, which ensures that it meets the highest international standards to ensure its quality, safety, and efficacy. To ensure equitable access, the developed vaccine will be offered to PAHO member states and territories through its Revolving Fund, which has been providing affordable vaccines in the region for more than 40 years. Bio-Manguinhos already has a sufficiently advanced plant for the production of the candidate vaccine, so there is no need to build a new plant.

"This will be a technology that adds to the adenovirus platform used in the Fiocruz/AstraZeneca vaccine for Covid-19. The development of a Fiocruz mRNA vaccine is a fundamental step towards Brazil's technological expertise in two key platforms for the advancement of immunobiological development. With this project and the WHO's support, we are reasserting our commitment to science and technology at the service of the people," says the Foundation's president, Nísia Trindade Lima.

According to the chairperson, it is still too early to talk about dates and timeframe, but the WHO's support will be decisive for the development of this vaccine to occur as soon as possible and within the international safety and quality protocols.

Besides being the supplier of this vaccine, Fiocruz has also committed itself, as part of the scope of the project presented to the WHO, to share its knowledge for the production of the vaccine with other laboratories in the region, guaranteeing the transfer of technology in order to expand the regional production capacity.

"The support that Bio-Manguinhos/Fiocruz is now receiving from PAHO and WHO represents recognition of our capabilities and will allow us to take another step forward in our journey to develop scientific and technological capabilities in state-of-the-art platforms for human vaccines. It will also allow us to contribute more decisively to increasing global equitable access to vaccines, with the potential for a true revolution in the development of other vaccines relevant to the Brazilian National Health System and to public health worldwide," said the director of Bio-Manguinhos, Mauricio Zuma.

For Bio-Manguinhos' Deputy Director of Technological Development, Sotiris Missailidis, the team's dedication has been fundamental to the advancement of the project. "The Technological Development team has worked tirelessly for years, with dedication and professionalism, seeking to achieve a level of excellence in the development of new products that meet the challenges of public health," he said.

Source: Fiocruz portal.