New initiative launched to advance mRNA vaccine development against human avian influenza (H5N1) – PAHO/WHO

July 29, 2024, Geneva, Switzerland — A new project aimed at accelerating the development and accessibility of human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates for manufacturers in low- and middle-income countries was launched today. Argentine manufacturer Sinergium Biotech will lead this effort by leveraging the World Health Organization (WHO) Medicines Patent Pool (MPP) mRNA Technology Transfer Program.

The mRNA Technology Transfer Programme, 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 Programme, has developed H5N1 vaccine candidates and aims to establish proof of concept in preclinical models. Once the preclinical data package is finalized, 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 exemplifies why WHO established the mRNA Technology Transfer Programme – to foster increased research, development and production in low- and middle-income countries, so that when the next pandemic hits, the world is better prepared to respond more effectively and more equitably,” 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 the MPP. “This project embodies our vision and demonstrates a strong commitment to preparing for and responding to future pandemics.”

Avian influenza viruses pose a significant risk to public health due to their widespread circulation among animals and their potential to cause a future pandemic. This development complements ongoing work within the framework of the Pandemic influenza preparedness framework Improve and strengthen the sharing of influenza viruses with human pandemic potential and increase access to vaccines for low- and middle-income countries.

“This announcement underscores the importance not only of geographically diversifying innovation and production of health technologies by including and recognizing the capabilities of Latin America and the Caribbean, but also the importance of early planning for access to and 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, CEO of Sinergium, said: “Sinergium’s increased ability and willingness to apply our expertise to H5N1 will play a vital role in this global pandemic preparedness effort. I would also like to thank PAHO, which has also been instrumental through its strong support to regional manufacturers in the Americas. We are excited to take on this public health challenge and our R&D team will continue to work closely with program partners.”

Since its inception, the mRNA Technology Transfer Programme has developed and deployed 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 hub where the platform was created and is being validated, and this technology is now being transferred to manufacturing partners to be adapted and improved 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 greater vaccine equity globally.

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