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

A new project aiming to accelerate the development and accessibility of human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates for manufacturers in low- and middle-income countries has been launched today. The Argentinian manufacturer Sinergium Biotech will lead this effort leveraging the World Health Organization (WHO) and the Medicines Patent Pool (MPP) mRNA Technology Transfer Programme.

The mRNA Technology Transfer Programme, jointly developed by WHO and MPP, was launched in July 2021 with the aim to build 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 Programme, has developed candidate H5N1 vaccines and aims to establish proof-of-concept in preclinical models. Once the preclinical data package is concluded, the technology, materials, and expertise will be shared with other manufacturing partners, aiding the acceleration of the development of H5N1 vaccine candidates, and bolstering pandemic preparedness efforts.

"This initiative exemplifies why WHO established the mRNA Technology Transfer Programme – to foster greater research, development and production in low- and middle-income countries, so that when the next pandemic arrives, the world will be better prepared to mount a more effective and more equitable response," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

"When we created the mRNA Technology Transfer Programme 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, Executive Director of MPP. “This project embodies our vision and demonstrates a strong commitment to future pandemic preparedness and response."

Avian influenza viruses are a significant public health risk due to their widespread circulation in animals and potential to cause a future pandemic. This development supplements ongoing work under the Pandemic Influenza Preparedness Framework to improve and strengthen the sharing of influenza viruses with human pandemic potential and increasing LMIC access to vaccines.

“This announcement underscores the importance of not only geographically diversifying the innovation and production of health technologies including and recognizing the capacities in Latin American and the Caribbean, but also the importance of early planning for access and the sharing of knowledge and technologies during the 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 enhanced capacity and readiness to apply our expertise to H5N1 will play a vital 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 manufacturers in the Americas. We are excited to tackle this public health challenge and our R&D team will continue to work closely with the Programme Partners."

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