Timeline of gain-of-function research

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Year Month and date Event type Details
2011 Early Experiments Two research groups, led by Yoshihiro Kawaoka at the University of Wisconsin–Madison and Ron Fouchier at Erasmus University Medical Center, conducte experiments on avian influenza H5N1. They serially passage the virus in ferrets to study its potential for airborne transmission in humans. The modified virus, adapted to replicate in mammalian lungs, demonstrates the ability to spread via respiratory droplets but shows decreased lethality compared to its original form.
2011 Early Reactions Proponents of the Kawaoka and Fouchier experiments argue that the research provides insights into how avian viruses could become airborne and facilitate the development of targeted vaccines and therapeutics. Critics, including some members of Congress, express concern over the risks, with some labeling the experiments as "engineered doomsday."
2012 January Review The WHO convenes an international technical consultation to evaluate the Kawaoka and Fouchier studies. The consultation acknowledges the importance of the research for public health surveillance and understanding H5N1 properties but calls for broader global discussions. The European Academies of Science Advisory Council (EASAC) confirms that existing regulations in the EU are adequate for conducting such research responsibly. In contrast, the US introduces a new policy for "Potential Pandemic Pathogen Care and Oversight" (P3CO) to regulate similar experiments.
2013 May Experiments A research group led by Hualan Chen at China's National Avian Influenza Reference Laboratory publishes findings from experiments conducted at the BSL3+ laboratory of the Harbin Veterinary Research Institute. They investigate the effects of a 2009 H1N1 infection combined with avian H5N1. The study finds that certain gene combinations in the dual-infection scenario can facilitate H5N1 transmission in mammals, but the modified viruses are less lethal.
2013 May Reactions Critics, including Simon Wain-Hobson and Robert May, condem Chen's research as unsafe and unnecessary. Concerns are raised about the biosafety of the laboratory, while others, including WHO's Masato Tashiro and Jeremy Farrar, praise the laboratory's standards and the study's insights into the H5N1 threat.
2022 October 14 Preprint Researchers at Boston University publish a preprint describing experiments where they spliced the SARS-CoV-2 BA.1 Omicron spike protein into an early SARS-CoV-2 variant. This creates a chimeric virus. The study reports higher mortality in mice exposed to the chimeric variant compared to those exposed to Omicron, suggesting mutations outside of spike proteins are significant determinants of pathogenicity.
2022 October 17 Media Coverage The Daily Mail publishes an article with the headline Boston University CREATES a new COVID strain that has an 80% kill rate, linking the research to fears of pandemic origins. The headline is later flagged for misinformation. Experts note the study was conducted following safety procedures and emphasize that the chimeric strain is less lethal than the original virus. Controversy also arise over whether the research requires additional gain-of-function review.

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