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Argentine bird flu vaccine developer Sinergium Biotech will share the “technology, materials, and expertise” behind its mRNA bird flu vaccine, to ensure an “equitable” global vaccine rollout should a global bird flu pandemic develop, the World Health Organization announced Monday.
The company is in the early stages of developing an mRNA vaccine candidate for H5N1, or bird flu, and is running preclinical models to establish proof-of-concept.
Once that is established — on an unspecified timeline — the company said it will share its data through the mRNA Technology Transfer Programme.
“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 WHO Director-General Tedros Adhanom Ghebreyesus, in a statement.
The program was established through a partnership between the WHO and the United Nations-backed Medicines Patent Pool to set up “locally owned” mRNA manufacturing facilities “in and for low- and middle-income countries.”
The program is based at a South African technology transfer hub, Afrigen, which provides technology development, transfer and training to 15 global partners. Partners include institutions in Ukraine, Serbia, Senegal, Nigeria, India, Indonesia and several other countries.
The technology transfer program was first set up to facilitate the distribution of the COVID-19 mRNA vaccines in poorer countries after Moderna and Pfizer, citing intellectual property rights, declined to share the technology necessary to produce the COVID-19 vaccines.
The program is largely funded by the African Union, the European Commission and several European and African countries. Leaders from Afrigen working with the program trained last year at the U.S. National Institute of Allergy and Infectious Diseases, formerly run by Dr. Anthony Fauci.
Initially, the WHO distributed the technology to the partners, Reuters reported. However, now one of the partners, Sinergium, will voluntarily share its vaccine with others in the network.
The Pan American Health Organization tapped Sinergium as a hub for the production of COVID-19 shots during the pandemic period. It is now developing its own mRNA vaccines.
“Partners interested in this will be able to start getting their fingers wet, beginning to practise with an H5N1 candidate so that if a pandemic was to start … they would already have the necessary tools in their facilities,” said Martin Friede, Ph.D., head of the WHO vaccine research unit.
Earlier this month, the U.S. government awarded $176 million to Moderna to develop and test its pre-pandemic mRNA vaccine against H5N1.
Late-stage testing would begin in 2025, pending results from the ongoing Phase 1/2 trial of five different mRNA vaccine options testing on about 1,500 people that concluded last week.
The contract includes options to speed up the development timeline if there is an increase in the number of human cases, the severity of the virus or if human-to-human transmission becomes possible.
The U.S. government is also in talks with Pfizer about possibly supporting its development of an mRNA vaccine targeting the H5 family of bird flu viruses, according to the Financial Times.
Both Moderna and Pfizer’s mRNA vaccine development is ahead of Sinergium’s, and Friede said the pharma giants would be able to roll out a vaccine more quickly than the Argentine company.
However, according to Reuters, “The scheme would allow Sinergium’s partners to begin production reasonably quickly and help to keep poorer countries from being reliant on handouts.”
Dr. Alejandro Gil, CEO of Sinergium, said, “Sinergium’s enhanced capacity and readiness to apply its expertise to H5N1 would play a vital role in this effort towards global pandemic preparedness.”
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Governments rolling out pandemic preparedness plans even though bird flu poses low risk to humans
According to the WHO program announcement, “Avian influenza viruses are a significant public health risk due to their widespread circulation in animals and potential to cause a future pandemic.”
However, the U.S. Centers for Disease Control and Prevention (CDC) continues to maintain that bird flu poses low risk to humans.
Bird flu outbreaks have occurred in wild birds globally and in poultry and some cattle in the U.S.
There have been a total of 14 reported human cases since 2022, according to the agency. Four occurred after exposure to dairy cows, 10 after exposure to poultry and none of the cases have been serious.
Yet, on Monday the U.S. Department of Health and Human Services issued a declaration of emergency, announcing that some flu viruses — including H5N1 bird flu — could cause a pandemic and threaten national security, The Defender reported.
The announcement amended a 2013 section of the Federal Food, Drug, and Cosmetic (FD&C) Act, which allows the agency to extend the availability of medical countermeasures to pandemic influenza A viruses, including the currently circulating H5N1 strain of bird flu.
The day after the announcement, on July 19, the American Medical Association announced an update to its Current Procedural Terminology codes to include a new code for bird flu vaccines, should they receive emergency use authorization from the U.S. Food and Drug Administration.
The creation of the codes also follows an agreement, announced on May 30, between the U.S. government and CSL Seqirus — one of the largest vaccine producers in the world — to complete 4.8 million doses of a “pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain,” as part of the U.S. National Pre-Pandemic Influenza Vaccine Stockpile program.
