The Argentina-based biotech firm,  Sinergium Biotech, has agreed to share know-how on the production of an mRNA vaccine for Avian influenza (H5N1) with WHO’s  Tecnology Transfer Hub so that an affordable vaccine could rapidly be produced for developing countries, WHO said Monday.

The agreement marks the first time that a vaccine developer has actually volunteered know-how to the hub, which was founded by WHO in 2021 together with the Medicines Patent Pool, and is hosted by the South African firm Afrigen, based in Cape Town.

Sinergium “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.” said WHO in a statement.

“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.

H5N1 is first vaccine target for the hub since COVID-19

Following it’s launch, the Afrigen mRNA Technology Transfer Programme focused mostly on testing and developing an mRNA COVID-19 vaccine candidate.  Progress, however, was slow because the major mRNA vaccine manufacturers, Moderna and Pfizer, refused to share their know-how on the WHO-sponsored platform – opting to sign licencing agreements to manufacture COVID vaccines under their brand identities with other manufacturers elsewhere in Africa.

So the agreement by Sinergium to share its IP and partner directly with the WHO co-hosted hub is a breakthrough for the global health agency – which has long sought a role in the emerging mRNA vaccine market –  to reduce costs and make vaccines more accessible in low- and middle-income countries.

The new agreement signed with a Latin-American based firm also takes a small, but meaningful, step towards the ‘regionalization’ of vaccine markets, WHO officials said on Monday.

“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 (PAHO), WHO’s Regional Office for the Americas.

Dr Alejandro Gil, Chief Executive Officer of Sinergium, credited PAHO’s “strong support it offers to regional manufacturers in the Americas” with playing an instrumental role in the deal.

“Sinergium’s enhanced capacity and readiness to apply our expertise to H5N1 will play a vital role in this effort towards global pandemic preparedness. …We are excited to tackle this public health challenge and our R&D team will continue to work closely with the Programme Partners.”

Along with the base at Afrigen, WHO’s mRNA technology transfer hub programme includes Institut Pasteur in Senegal – and is planned to eventually includes manufacturers in over a dozen other low- and middle-income countries around the world.

Moderna also advancing a candidate vaccine with US government help

Moderna is reportedly at a more advanced stage in the process of developing and mRNA vaccine for the virus, which is spreading rapidly amongst dairy cattle herds in the United States.  In early July, the US government awarded the Cambridge-based firm $176 million to advance development of “an mRNA-based pandemic influenza vaccine.”

“We have successfully taken lessons learned during the COVID-19 pandemic and used them to better prepare for future public health crises. As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities,” said HHS Secretary Xavier Becerra, at the time of the announcement.

While WHO has so far assured that the risks to humans of avian flu remain low, as long as human-to-human transmission is not occurring, the ever-widening transmission of the deadly virus amongst different animal species increases the risks that it may one day soon mutate in a way that it can more easily infect, and be transmitted, amongst humans.

And in the absence of effective vaccines, which are also widely available, that could unleash yet another pandemic on the world.

Image Credits: Afrigen, CDC/ Courtesy of Cynthia Goldsmith, CDC.