Vaccine in preclinical study could be a new product to be provided for the Pan American Health Organization to distribute in Latin America and Caribbean
The Oswaldo Cruz Foundation, through its Institute of Technology on Immunobiologicals (BioManguinhos/Fiocruz), was selected by the World Health Organization as a center for development and production of vaccines with messenger RNA technology in Latin America.
The selection is the result of a call for expressions of interest launched worldwide on 16 April 2021, which generated around thirty responses from Latin American companies and scientific institutions, with the aim of increasing production capacity and expanding access to vaccines against Covid-19 in the Americas.
Bio-Manguinhos/Fiocruz was one of the two centers selected after a selection process carried out by a committee of independent experts (PDVAC). The other selected proposal is located in the Argentine Republic.
The choice for Bio-Manguinhos/Fiocruz occurred due to the promising advances in technological development of an mRNA vaccine against Covid-19, currently in the preclinical and which used resources from the Ministry of Health and parliamentary amendments in its development.
The candidate is based on self-replicating RNA technology, and expresses not only the Spike protein, but also N protein, for better immune response. This technology demands less productive needs, reaching a scale in terms of doses higher than that of other mRNA vaccines. This allows its cost to be lower than other similar vaccines, allowing the expansion of its access.
PAHO/WHO is making available to Fiocruz a team of international experts with experience in the different aspects of development and production of vaccines of this nature. Its cooperation with the South African consortium also chosen by WHO, with the Argentine center and other producers in the region.
Once developed, the vaccine will go through WHO prequalification process, which will guarantee compliance with the highest international standards of quality, safety and effectiveness.
To ensure equitable access, the vaccine developed will be offered to member states and PAHO territories through its Revolving Fund, which has provided affordable vaccines for over 40 years in the region.
As a project scope, Bio-Manguinhos/Fiocruz is committed to sharing its knowledge for vaccine production with other laboratories in the region, guaranteeing them the technology transfer to expand regional production capacity.
According to the president of Fiocruz, Nisia Trindade Lima, “this will be a technology that add to the adenovirus platform, used in the Fiocruz/AstraZeneca vaccine for Covid-19. The development of a Fiocruz mRNA vaccine is a fundamental step for Brazil to hold the technological mastery of two fundamental platforms for the advancement of development of immunobiologicals. With this project and the support of WHO, we are reaffirming our commitment to science and technology at the service of the population”.
“The support that Bio-Manguinhos/Fiocruz now receives from PAHO and WHO is configured as a recognition of our competence and will allow us to take another step in our journey of development of scientific and technological capabilities on state-of-the-art platforms for human vaccines. It will also allow us to contribute more decisively to increasing equity world in access to vaccines, with the potential for a true revolution in the development of other vaccines of interest to the Brazilian Publich Health System and to global public health”, stated the director of Bio-Manguinhos, Mauricio Zuma.
“The technological development team has worked tirelessly for years with dedication and professionalism, seeking to reach a level of excellence in the development of new products that meet public health challenges. We have reached a level of maturity that allowed us to advance, in the short term, in the development of an RNA vaccine against COVID-19, which provided input for the approval of our proposal by WHO. This result represents the recognition of our scientific competence and our potential in the face of international institutions. We are very happy and grateful for the opportunity, as with the support of PAHO/WHO it will be possible to transform Bio-Manguinhos into a development hub, production and transfer of our technology to other countries, ensuring the leading role of Latin America on the world stage for the development of new vaccines”, highlighted the vice director of Technological Development of Bio-Manguinhos, Sotiris Missailidis.