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U.S. Moratorium(ish) on Gain-of-Function Research

Evaluating the effectiveness of the 2014 U.S. moratorium on gain-of-function experiments

In the last two articles, we discussed the vindication of the lab leak theory through the publication of several investigative articles, and the risky nature of gain-of-function research and the evidence that it may be a key component to the cause of the COVID-19 pandemic. Now, we turn to the U.S. Due to the risky nature of gain-of-function research, what actions has the U.S. government taken to mitigate those risks?

In 2014, the U.S. government placed a moratorium on new gain-of-function experiments for influenza, MERS, and SARS. That moratorium defines “gain-of-function” in very broad terms covering any “research that improves the ability of a pathogen to cause disease.” The moratorium expired in 2017 and was replaced by an oversight board, the Potential Pandemic Pathogens Control and Oversight Framework (P3CO) that reviews federally funded gain-of-function research. EcoHealth Alliance defines gain-of-function more specifically as enhancing viruses that infect humans, not enhancing viruses that infect animals.

Microscopic image of SARS-CoV-2

The differences in definitions are why there is some debate as to whether Dr. Fauci was lying when he said the NIH does not fund gain-of-function research at the Wuhan Institute of Virology. But, as Nicholas Wade points out, “Definitions aside, the bottom line is that the National Institutes of Health was supporting research of a kind that could have generated the SARS2 virus, in an unsupervised foreign lab that was doing work in BSL2 biosafety conditions.”

By “BSL2” he is saying that the laboratory, which was doing high-risk research, was only using safety precautions that an out-patient medical facility would use. (He compared it to a dental office.) Gain-of-function research on pathogens with no known vaccine or treatment should be conducted in BSL-4 labs, if they should be conducted at all. BSL-4 labs require full-body protective gear.

Eban’s Vanity Fair article uncovered internal discussions about NIH funding:

Inside the NIH, which funded such research, the P3CO framework was largely met with shrugs and eye rolls, said a longtime agency official: “If you ban gain-of-function research, you ban all of virology.” He added, “Ever since the moratorium, everyone’s gone wink-wink and just done gain-of-function research anyway.” 

Katherine Eban, “The Lab-Leak Theory: Inside the Fight to Uncover COVID-19’s Origins” at Vanity Fair

The 2014 moratorium had an exception for research that was of national interest, and certainly, preventing a global pandemic should be a concern for any government. Whether gain-of-function studies is the best way to do so is debatable. Eban mentions a 2015 paper authored by Shi Zheng-Li and Ralph Baric of UNC in which they did gain-of-function studies combining a protein from a Chinese rufous horseshoe bat with the genome of SARS-CoV that they then tested on humanized mice (i.e., mice with the ACE2 gene). The result was a highly infectious pathogen. Shi and Baric said in the paper that this research may be deemed by scientific review panels as too risky to pursue.

As Eban points out about the 2015 paper:

In fact, the study was intended to raise an alarm and warn the world of “a potential risk of SARS-CoV re-emergence from viruses currently circulating in bat populations.” The paper’s acknowledgments cited funding from the U.S. National Institutes of Health and from a nonprofit called EcoHealth Alliance, which had parceled out grant money from the U.S. Agency for International Development. 

Katherine Eban, “The Lab-Leak Theory: Inside the Fight to Uncover COVID-19’s Origins” at Vanity Fair

If the COVID-19 pandemic was a result of a pathogen created from gain-of-function studies, the critics of gain-of-function research would be vindicated, and any virologists who may very well run top-notch labs doing research that they believe will help people will have to shut down because one lab was sloppy, secretive, and cavalier with their research.

Eban quotes Jamie Metzl, who sits on the WHO’s advisory committee on genome editing and who started a blog on the lab leak hypothesis in April 2020. Metzl says Peter Daszak responded quickly to suggestions of a lab leak because

“If zoonosis [i.e., arising from animals] was the origin, it was a validation…of his life work…. But if the pandemic started as part of a lab leak, it had the potential to do to virology what Three Mile Island and Chernobyl did to nuclear science.” It could mire the field indefinitely in moratoriums and funding restrictions. 

Katherine Eban, “The Lab-Leak Theory: Inside the Fight to Uncover COVID-19’s Origins” at Vanity Fair

You may also wish to read the first two articles in this three-part series:

Lab Leak Theory Vindicated: What That Means for Fighting COVID-19. Vanity Fair adds to the growing number of investigative articles pointing to a lab accident as the cause of the COVID-19 pandemic. This article looks at the U.S. government’s role in downplaying that lab leak theory. (Heather Zeiger)

What Is Gain-of-Function Research and Why Is It Risky? The Wuhan Institute of Virology and the NIH find themselves in a tough spot. To understand why some in the U.S. government and the NIH want to downplay funding of gain-of-function research, we need to understand what exactly it is. (Heather Zeiger)

Heather Zeiger

Heather Zeiger is a freelance science writer in Dallas, TX. She has advanced degrees in chemistry and bioethics and writes on the intersection of science, technology, and society. She also serves as a research analyst with The Center for Bioethics & Human Dignity. Heather writes for bioethics.com, Salvo Magazine, and her work has appeared in RelevantMercatorNet, Quartz, and The New Atlantis.

U.S. Moratorium(ish) on Gain-of-Function Research