Fiocruz is selected as a WHO hub for mRNA vaccines

The Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) was selected last Tuesday (September 21st) by the World Health Organization (WHO) as a hub for the development and production of vaccines using messenger RNA in Latin America. This Foundation unit was chosen due to the promising advancements in the technological development of an mRNA vaccine against Covid-19, currently in a pre-clinical stage. The initiative used resources of the Ministry of Health and of parliamentary amendments for its development.

The choice was the result of a worldwide call launched on April 16th, 2021 with the goal of increasing production capacity and extending access to vaccines against COVID-19 in the Americas. About thirty Latin American companies and scientific institutions participated. The selection process was held by a committee of independent specialists (PDVAC). In addition to Fiocruz, another proposal, in Argentina, was also selected.

According to the WHO, Bio-Manguinhos/Fiocruz was chosen for its long tradition in the production of vaccines and for the advancements it has presented for the development of an innovative mRNA vaccine against COVID-19. The candidate vaccine is based on the self-replicating RNA technology, and expresses not only the spike protein, but also protein N, for a better immune response. This technology requires fewer production demands and achieves a scale of a number of doses superior to other mRNA vaccines. This results in costs inferior to those of other similar vaccines, therefore making it possible to expand access to them. The vaccine is currently ongoing in a pre-clinical trial phase.

As a result of the selection, the PAHO/WHO will provide Fiocruz with a team of international specialists with experience in the different aspects of developing and producing vaccines of this kind. Cooperation with the South-African consortium, also chosen by the WHO, with the Argentinian hub and with other manufacturers in the region is also expected to take place.

Once developed, the candidate vaccine will go through the WHO pre-qualification process, to ensure that the highest international standards are complied with so as to guarantee its quality, safety, and efficacy. In order to ensure equitable access, once developed this vaccine will be offered to the PAHO member states and territories through its Rotary Fund, which has been supplying accessible vaccines in the region for over 40 years. Bio-Manguinhos already has a sufficiently advanced production plant to manufacture the candidate vaccine and no new factories would need to be built.

“This technology will add to the adenovirus platform already in use for the Fiocruz/AstraZeneca COVID-19 vaccine. Developing a Fiocruz mRNA vaccine is a crucial step to make sure Brazil holds the technological domain of two fundamental platforms for the advancement of immunobiological development. With this project and with the support of the WHO, we are once again stating our commitment with science and technology at the service of the population”, comments Fiocruz president, Nísia Trindade Lima.

According to Lima, it is still early to mention dates or schedules, but the WHO support will be decisive to make sure this vaccine is developed as soon as possible and within global safety and quality protocols.

In addition to being a supplier of this vaccine, Fiocruz has also committed, as part of the scope of the project presented to the WHO, to sharing its vaccine production knowledge with other laboratories in the region, ensuring technology transfer to expand the region’s production capacity.

“The support Bio-Manguinhos/Fiocruz is currently receiving from the PAHO and the WHO is an acknowledgment of our competence and will allow us to climb yet another step in our journey to develop scientific and technological qualifications in last-generation platforms for human vaccines. It will also allow us to contribute in a more decisive manner to increase worldwide equity in access to vaccines, with the potential for a veritable revolution in the development of other vaccines of interest for the Unified Health System (SUS, acronym in Portuguese for the Brazilian public health system) and for global public health”, stated Bio-Manguinhos director, Mauricio Zuma.

For Sotiris Missailidis, vice-director of Technological Development of Bio-Manguinhos, the dedication of the staff has been crucial to move the project forward. “The Technological Development team has worked tirelessly for years, with dedication and professionalism, to reach a level of excellence in the development of new products that meet the challenges of public health”, he highlighted.