Sinergium paves the way for Latin American mRNA vaccines with new preclinical study

OSLO/ BUENOS AIRES, 10 DEC—In a milestone for South America, scientists at Argentina’s pharmaceutical company Sinergium Biotech will start preclinical testing of an innovative mRNA vaccine technology that could significantly strengthen regional pandemic preparedness and contain escalating disease outbreaks in their tracks.

Backed by a US $1 million investment from CEPI, the exploratory project is among the first mRNA vaccine technologies to be assessed on the continent.

The research will evaluate Sinergium’s mRNA platform—supported by the World Health Organization (WHO) and Medicines Patent Pool’s mRNA Technology Transfer Programme, and by the Pan American Health Organization (PAHO)—in preclinical studies using H5N1 avian flu as a prototype pathogen.  The Americas have reported recent outbreaks of the virus which is now widespread in farmed and wild birds globally. It has also been detected in several mammal species and in rare, sporadic human cases linked to direct exposure, underscoring its potential to spark a future pandemic. 

Designed as a flexible, ‘plug-and-play’ platform, the mRNA technology, if successful, also aims to target other emerging viruses beyond H5N1 that pose threats to the region. The project therefore supports CEPI’s mission, endorsed by the G7 and G20, to develop vaccines against a new ‘Disease X’—a term used for an unknown pathogen with pandemic potential—within 100 days of viral discovery and stop outbreaks before they spiral into a pandemic.

Sinergium is working in collaboration with the Laboratory of Nucleic Acid immunotechnology, LITAN, from University of Buenos Aires-CONICET, on the project.

“mRNA vaccines transformed our response to COVID-19, but many nations still lack the capabilities, training and know-how to develop and produce these vaccines at scale, putting populations at risk of once again being pushed to the back of the queue during a future crisis,” explains Dr. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI). “Our partnership with Sinergium—CEPI’s first in Argentina—harnesses the power of this technology to pave the way for local scientists and public health experts to respond rapidly and equitably to future threats in the region, while building vital local R&D capacity and enhancing the continent’s health security.”

“This partnership with CEPI enables Sinergium to accelerate its efforts to consolidate mRNA research and manufacturing capabilities in Latin America. Sinergium has a strong commitment to public health and low- and middle-income countries (LMICs). Building collaborations is fundamental to expediting our research and development (R&D) pipeline and to impacting our people earlier,” states German Sanchez Alberti, Sinergium’s R&D Manager. “CEPI provides a comprehensive toolkit of technical expertise that can undoubtedly make a significant difference to our project not only for the region of the Americas, but also to expand it to other interested parties in LMICs.”

The CEPI-Sinergium partnership aligns with a broader joint commitment between CEPI and PAHO to strengthen research, manufacturing and clinical trial capacity across Latin America and the Caribbean.

“This announcement demonstrates that the Americas have the talent, capacity and expertise to advance the development and production of safe, effective and quality-assured vaccines,” said Tomás Pippo, Acting Chief of the Innovation and Regional Production Platform at PAHO. “This CEPI–Sinergium partnership, supported by PAHO, is a decisive step toward self-reliance that will increase vaccine production and reduce dependence on external suppliers, pushing the region toward more equitable protection against emerging pandemics.”

CEPI and Sinergium are committed to enabling equitable access to the outputs of their partnership, in line with CEPI’s Equitable Access Policy. CEPI holds the right to fund the technology further, should it be successful in the preclinical trials. Should a vaccine be developed using CEPI funding, CEPI and Sinergium are committed to vaccines being available first to at-risk populations when and where needed at an affordable price. Project results and data will be published open access to benefit the global scientific community.

Sinergium joined the WHO and MPP mRNA Technology Transfer programme in 2021. The global initiative seeks to create locally owned mRNA manufacturing capabilities in and for low- and middle-income countries and expand global access to mRNA vaccines. Sinergium also works with PAHO under a technical cooperation agreement to strengthen mRNA vaccine development and production in Argentina and across the Americas. The partnership aims to expand local capacities, support sustainable technology transfer and promote equitable access to vaccines in the region.

ENDS

About CEPI 

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ to accelerate the time taken to develop safe, effective, accessible vaccines against new threats to just 100 days. Learn more at CEPI.net. 

About Sinergium Biotech

Sinergium Biotech, an Argentine biopharmaceutical company, specialized in the research, development, production, and commercialization of vaccines and highly complex biopharmaceutical products. Sinergium has manufactured and distributed over 300 million doses of vaccines in Latin America’s public markets in partnership with leading multinational companies, enabling access to the latest technologies for the population. Sinergium Biotech is a member of the mRNA Tech Transfer Hub established by the World Health Organization (WHO) and the Medicines Patent Pool (MPP) since 2021. The company is currently developing mRNA research and development (R&D) and Good Manufacturing Practices (GMP) capabilities in Argentina. Learn more at https://www.sinergiumbiotech.com/en/ 

About PAHO 

The Pan American Health Organization (PAHO) works with the countries of the Americas to improve the health and quality of life of its population. Founded in 1902, it is the world’s oldest international public health agency. It serves as the Regional Office of WHO for the Americas and is the specialized health agency of the Inter-American system (OAS). www.paho.org