New mRNA vaccine initiative targets avian influenza (H5N1)

The World Health Organization (WHO) and the Medicines Patent Pool (MPP) have launched a groundbreaking initiative to accelerate the development of mRNA vaccines for avian influenza (H5N1). This initiative, announced on July 29, 2024, is a significant step in enhancing global pandemic preparedness, particularly for low- and middle-income countries (LMICs).

The project is spearheaded by Sinergium Biotech, an Argentinian manufacturer and a partner in the WHO–MPP mRNA Technology Transfer Program. The primary goal is to develop and make accessible mRNA vaccine candidates for H5N1, a strain of avian influenza that can potentially cause severe human illness and pandemics.

The mRNA Technology Transfer Program was initiated in July 2021 to build capacity in LMICs to develop and produce mRNA-based vaccines. This program aims to democratize access to cutting-edge vaccine technology, ensuring that more regions can independently develop and produce vaccines. This capability is crucial for a swift and equitable response to future pandemics.

Sinergium Biotech has already developed candidate H5N1 vaccines and is establishing proof-of-concept in preclinical models. Once this stage is completed, the technology, materials, and expertise will be shared with other manufacturing partners. This collaborative approach aims to expedite the development of H5N1 vaccine candidates and strengthen pandemic preparedness efforts globally.

"This initiative exemplifies why WHO established the mRNA Technology Transfer Program 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 Tedros Adhanom Ghebreyesus, PhD, WHO Director-General, in the release.

"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," highlighted Charles Gore, Executive Director at MPP. “This project embodies our vision and demonstrates a strong commitment to future pandemic preparedness and response."

Avian influenza viruses pose a significant public health risk due to their widespread circulation in animals and their potential to jump to humans, leading to pandemics. This initiative complements ongoing work under the Pandemic Influenza Preparedness Framework, which aims to improve and strengthen the sharing of influenza viruses with human pandemic potential and increase LMIC access to vaccines.

"This announcement underscores the importance of not only geographically diversifying the innovation and production of health technologies but also the importance of early planning for access and the sharing of knowledge and technologies during the research and development processes," emphasized Jarbas Barbosa, PhD, MS, Director of the Pan American Health Organization (PAHO).

In the release, Alejandro Gil, PhD, Chief Executive Officer of Sinergium, expressed enthusiasm about the initiative. "Sinergium’s enhanced capacity and readiness to apply our expertise to H5N1 will play a vital role in this effort toward global pandemic preparedness. I would also like to thank PAHO for their strong support to regional manufacturers in the Americas,” said Gil.  “We are excited to tackle this public health challenge, and our R&D team will continue to work closely with the Program Partners."

The mRNA Technology Transfer Program has already demonstrated success with its platform, which was used to establish the immunogenicity, efficacy, and safety of a COVID-19 vaccine candidate in preclinical animal models. Afrigen, the center where this platform was created and validated, is now transferring the technology to manufacturing partners for adaptation and enhancement for other critical disease targets.

This initiative is vital to WHO and MPP’s efforts to improve the availability, access, and use of mRNA vaccines, ultimately aiming for global vaccine equity. As the world faces ongoing and future threats of pandemics, such collaborative and innovative efforts are essential to safeguard public health globally.