WHO launches project to develop H5N1 mRNA vaccine in LMICs

SWITZERLAND—The World Health Organisation (WHO) has announced a pioneering initiative to accelerate the development and accessibility of human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates, with a focus on manufacturers in low- and middle-income countries (LMICs).

Sinergium Biotech, an Argentinian manufacturer, will spearhead this initiative, leveraging the WHO and Medicines Patent Pool (MPP) mRNA Technology Transfer Programme.

Launched in July 2021, the mRNA Technology Transfer Programme is a collaborative effort by WHO and MPP designed to enhance the capacity of LMICs to develop and produce mRNA-based vaccines.

As a partner of this programme, Sinergium Biotech has already developed candidate H5N1 vaccines and aims to establish proof-of-concept in preclinical models.

Upon completion of the preclinical data package, the technology, materials, and expertise will be shared with other manufacturing partners, accelerating the development of H5N1 vaccine candidates and strengthening pandemic preparedness efforts.

Commenting on the initiative, Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized that this project exemplifies the core mission of the mRNA Technology Transfer Programme.

He noted that the programme was established to foster greater research, development, and production capabilities in LMICs, ensuring a more effective and equitable response to future pandemics.

Echoing this sentiment, Charles Gore, Executive Director of MPP, highlighted that the creation of the mRNA Technology Transfer Programme in collaboration with WHO enables LMICs to lead development efforts, foster collaboration, share resources, and disseminate knowledge.

He asserted that this project embodies MPP’s vision and commitment to future pandemic preparedness and response.

Dr. Jarbas Barbosa, Director of the Pan American Health Organization (PAHO), also underscored the significance of diversifying the innovation and production of health technologies geographically, recognizing the capacities in Latin America and the Caribbean.

He stressed the importance of early planning for access and the sharing of knowledge and technologies during the research and development processes.

Furthermore, Dr. Alejandro Gil, Chief Executive Officer of Sinergium, expressed confidence in Sinergium’s enhanced capacity and readiness to contribute to H5N1 vaccine development.

He thanked PAHO for their unwavering support to regional manufacturers in the Americas and expressed excitement about tackling this public health challenge.

Dr. Gil assured that Sinergium’s R&D team will continue to work closely with the Programme Partners.

The WHO’s initiative is crucial as avian influenza viruses pose a significant public health risk due to their widespread circulation in animals and the potential to cause future pandemics.

This development complements ongoing efforts under the Pandemic Influenza Preparedness Framework to improve the sharing of influenza viruses with human pandemic potential and increase LMIC access to vaccines.

Since its inception, the mRNA Technology Transfer Programme has developed and implemented a platform for establishing the immunogenicity, efficacy, and safety of a COVID-19 vaccine candidate in preclinical animal models.

Afrigen, the center where the platform was created and validated, is now transferring this technology to manufacturing partners to adapt and enhance it for other critical disease targets.

The progress made by the mRNA Technology Transfer Programme is vital to WHO and MPP’s efforts to improve the availability, access, and use of mRNA vaccines, ultimately striving for better vaccine equity globally.