Rio de Janeiro, Brazil & Brussels, Belgium — September 2026

Bio-Manguinhos/Fiocruz and Quantoom Biosciences today highlighted a major milestone in Brazil’s mRNA vaccine development: Anvisa, Brazil’s National Health Surveillance Agency, has authorized the start of clinical trials for the country’s first mRNA vaccine, developed on Bio-Manguinhos/Fiocruz’s proprietary mRNA platform, supported by Quantoom Biosciences’ Ntensify® technology for RNA production and purification. 

This authorization positions Bio-Manguinhos/Fiocruz as the first partner within the WHO Global mRNA Technology Transfer Programme and the Medicines Patent Pool (MPP) initiative to advance a product to clinical trial stage. Fiocruz’s pilot plant is also the first in Latin America to hold Good Manufacturing Practice (GMP) certification for RNA production. 

The vaccine, targeting COVID-19 as a booster dose in line with Brazil’s National Immunization Program, completed preclinical, toxicology and scale-up studies before receiving Anvisa’s authorization. Participant recruitment for Phase 1 is scheduled to begin in the first quarter of 2027, pending Research Ethics Committee approval. 

Building National mRNA Manufacturing Capacity 

This milestone demonstrates the feasibility of an end-to-end mRNA manufacturing ecosystem, enabling:  

• Rapid vaccine design and production supporting national health-emergency preparedness  

• Local manufacturing capability reducing reliance on external technologies.  

• A scalable platform for future products, including candidates against leishmaniasis, tuberculosis and cancer already under study 

Quantoom’s RNA production and purification technologies contributed to development activities conducted within Bio-Manguinhos/Fiocruz’s national mRNA platform, supporting efforts to expand local manufacturing capabilities and strengthen regional technological autonomy.

“Seeing Ntensify support Fiocruz’s journey to Brazil’s first mRNA vaccine reaching clinical trials is a powerful demonstration of how our technology enables national platforms to move from lab to patient,” said José Castillo, CEO, Quantoom Biosciences. 

About Bio-Manguinhos/Fiocruz 

Bio-Manguinhos/Fiocruz is Brazil’s Institute of Technology on Immunobiologicals, part of the Oswaldo Cruz Foundation (Fiocruz). Recognized by WHO since 2021 as a reference center for mRNA vaccines in Latin America, Bio-Manguinhos leads Brazil’s mRNA platform under the Program for the Expansion and Modernization of the Health Economic-Industrial Complex (PDCEIS), with funding from the Ministry of Health, BNDES and PAHO. 

About Quantoom Biosciences  

Quantoom Biosciences is a full-stack RNA partner dedicated to accelerating the development and manufacturing of mRNA- and saRNA-based vaccines and therapeutics. Founded in June 2021 by José Castillo, Quantoom built the N-Force™ toolbox — combining Ncode™ for sequence design and optimization, Ntensify® for construct-agnostic RNA production, and Ncapsulate® for RNA-LNP formulation — to give partners an integrated path from sequence to patient. Ntensify®, launched in 2023, scales seamlessly from microgram-scale research experiments to multi-gram and GMP-grade commercial manufacturing, and has been adopted by research institutions, biotechs, and CDMOs around the world. 

Contacts 

Quantoom Biosciences – Thomas GUYON, Product Marketing (t.guyon@quantoom.com) 

Fiocruz  – Pamela Lang , Head of Communications (pamela.lang@bio.fiocruz.br)

References to Bio-Manguinhos/Fiocruz in this communication are intended solely to describe factual aspects of a collaboration and do not constitute endorsement, recommendation, certification, approval or preference regarding any product, technology, service or supplier.