Washington, D.C., September 15, 2026. The Brazilian Health Regulatory Agency (ANVISA) has authorized the progression to Phase I clinical trials of the COVID-19 messenger RNA (mRNA) vaccine candidate developed by Bio-Manguinhos/Fiocruz with support from the Pan American Health Organization (PAHO), the World Health Organization (WHO), the Medicines Patent Pool (MPP), and Global Affairs Canada (GAC). This is the first mRNA vaccine developed in Latin America and the Caribbean to advance to the clinical trial stage.
The authorization will allow for the evaluation of the vaccine's safety and immunogenicity in healthy adults through a Phase I clinical study. The vaccine candidate uses messenger RNA technology to express the SARS-CoV-2 Spike protein and is the first product developed from Bio-Manguinhos/Fiocruz’s proprietary mRNA platform.
This milestone represents a significant achievement for the WHO, MPP, and PAHO mRNA Technology Transfer Programme, part of a global initiative aimed at expanding access to this technology and strengthening vaccine manufacturing capacity in low- and middle-income countries. PAHO has played a key role in supporting the regional implementation of the initiative and fostering the development of sustainable production capacities in the Americas.
The mRNA platform developed by Fiocruz marks an important advance in the region’s health innovation capacities. The infrastructure and knowledge generated through this effort can be leveraged to develop vaccines and therapeutics targeting other public health challenges, including diseases with pandemic potential, emerging infectious diseases, leishmaniasis, tuberculosis, and various types of cancer. Messenger RNA technology holds considerable promise for addressing future pandemic threats.
“Strengthening innovation and production capacities in Latin America and the Caribbean is strategic to ensuring the availability of safe and effective health technologies that respond to the health priorities of our Member States and to improving preparedness for future emergencies,” said Tomás Pippo, Acting Head of PAHO’s Regional Platform for Innovation and Production.
The COVID-19 pandemic highlighted the need to strengthen regional capacities for the research, development, and production of vaccines and other health technologies. Local production capacities can help to reduce reliance on external suppliers, accelerate responses to future health emergencies, and contribute to more equitable access to essential health products across Latin America and the Caribbean.
PAHO’s Regional Platform for Innovation and Production, with support from Global Affairs Canada and other partners, has collaborated on this and other regional initiatives to strengthen innovation, manufacturing, and regulatory capacities as key pillars for improving access to health technologies.
