New initiative launched to advance mRNA vaccine development against human avian influenza (H5N1)

A new project was launched today that aims to accelerate the development and availability of messenger RNA (mRNA) vaccine candidates against human avian influenza (H5N1) for producers in low- and middle-income countries. Argentinian manufacturer Sinergium Biotech will lead this effort using the World Health Organization (WHO) mRNA Technology Transfer Program and the Medicines Patent Pool (MPP).

The mRNA Technology Transfer Program, jointly developed by WHO and MPP, was launched in July 2021 with the aim of building capacity in low- and middle-income countries (LMICs) for the development and production of mRNA-based vaccines. Sinergium Biotech, a partner in the mRNA Technology Transfer Program, has developed H5N1 vaccine candidates and aims to establish proof of concept in preclinical models. Once the preclinical data package is assembled, the technology, materials and expertise will be shared with other manufacturing partners, helping to accelerate the development of H5N1 vaccine candidates and strengthen pandemic preparedness efforts.

“This initiative is an example of why WHO established the mRNA Technology Transfer Program – to encourage greater research, development and production in low- and middle-income countries, so that when the next pandemic hits, the world is better prepared to mount a more effective and equitable response,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General.

“When we created the mRNA Technology Transfer Program with WHO, our goal was to enable low- and middle-income countries to lead development efforts, foster collaboration, share resources and disseminate knowledge,” said Charles Gore, MPP Executive Director. This project embodies our vision and demonstrates a strong commitment to future pandemic preparedness and response.”

Avian influenza viruses pose a significant risk to public health due to their widespread circulation among animals and the potential to cause a future pandemic. This development complements ongoing work in the framework Pandemic Influenza Preparedness Framework improve and strengthen the exchange of influenza viruses with human pandemic potential and increase access to vaccines with LMIC.

“This announcement highlights the importance of not only the geographic diversification of health technology innovation and production, including the identification of capacity in Latin America and the Caribbean, but also the importance of early planning for accessing and sharing knowledge and technologies during research and development processes,” said Dr. Jarbas Barbosa , director of the Pan American Health Organization.

dr. Alejandro Gil, Chief Executive Officer of Sinergium, said: “Sinergium's increased capacity and willingness to apply our expertise to H5N1 will play a key role in this effort towards global pandemic preparedness. I would also like to thank PAHO who have also been instrumental through the Strong support it offers to regional producers in the Americas, we are excited to tackle this public health challenge and our research and development team will continue to work closely with program partners.”

Since its inception, the mRNA Technology Transfer Program has developed and implemented a platform that has been used to determine the immunogenicity, efficacy, and safety of COVID-19 vaccine candidates in preclinical animal models. Afrigen is the center where the platform was created and validated, and this technology is now being transferred to manufacturing partners to adapt and improve it for other critical disease targets. The progress made by the mRNA Technology Transfer Program is a vital part of WHO and MPP efforts to improve the availability, access and use of mRNA vaccines for better vaccine equity globally.