Virologists push back on more regulation of viruses made more lethal in the lab

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An electron microscope image shows SARS-CoV-2. (Photo credit: NIH)

Virologists pushed back on the possibility of tighter regulation of viruses tweaked in the lab to be more lethal at a public meeting Wednesday.

An enhanced pandemic potential pathogen is a virus or microbe that has gained increased transmissibility —  capacity to spread from person to person and reverberate throughout a population —  or virulence — capacity to cause serious disease.

Experiments that are reasonably anticipated to generate deadlier pathogens are supposed to receive heightened oversight from the Department of Health and Human Services under what is nicknamed the HHS “P3CO,” short for the pandemic potential pathogen committee.

Though established just a few years ago, critics say the committee’s work is hidden from public view, suffers from glaring loopholes and needs a reboot. Work that contributes to vaccine development or results from viral surveillance efforts in nature is exempted from this extra layer of review, for example. 

Speculation by some in the U.S. intelligence community that SARS-CoV-2 may have seeped out of a lab at the pandemic’s epicenter may have prompted a public meeting to consider whether current policies are adequate. Reporting irregularities by a nonprofit partner of the lab involved in gain-of-function research on coronaviruses and funded by the National Institutes of Health called EcoHealth Alliance has also led many to conclude the P3CO needs to apply to more research projects and be more accountable to the public.

One million Americans have died of COVID-19. A review by the U.S. intelligence community last summer about whether the novel coronavirus spilled over from an animal or spilled out of a lab was inconclusive.

The Office of Science and Technology Policy and NIH cohosted the meeting Wednesday.

White House COVID-19 testing czar Tom Inglesby was harshly critical of the existing framework. His top recommendation: Scientists should be required to explain in detail the goals of undertaking such research in the first place, and why less perilous methods could not reach the same goal. 

“There must be an extraordinary and public justification,” he said. “I do think there are experiments we shouldn’t do.”

But lobbying groups representing virologists and other life scientists pushed back.

“The systems of review should not be a solution looking for a problem,” said Felicia Goodrum, president of the American Society for Virology. 

Goodrum said regulation risks “tying two hands behind our backs” when it comes to modeling pandemic risks. 

Goodrum added that the inherently unpredictable nature of manipulating viruses means that it’s unwieldy to determine whether or not an experiment will make a virus more dangerous, so the regulations should be lax.

“We must be careful about dichotomizing research as simply either ‘risky’ or not because it is not possible to absolutely predict the biology of a virus with the committee,” she said.  

But Gregory Koblentz, director of the biodefense graduate program at George Mason University, said that an EcoHealth Alliance grant that funded research that made coronaviruses more deadly by swapping their spike proteins is emblematic of lapses in oversight at NIH. 

The research was not regulated as gain-of-function work, but NIH did add language to the grant requiring extra reporting if the viral engineering led to viruses that were 10 times more pathogenic. (The chimeric viruses proved to be much more pathogenic than even that threshold, but EcoHealth Alliance did not report it.) That language amounts to a “tacit admission” that NIH reasonably anticipated the work was gain of function, Koblentz said.

Stefano Bertuzzi, CEO of the American Society for Microbiology, conceded that labs should report more often to Congress and that scientists could do a better job allaying public concerns, but stated that the framework is otherwise sufficient. 

Bertuzzi signaled he is concerned that Congress could step in.

Labs taking steps toward greater transparency “helps guard against well intended but sometimes overly prescriptive legislative approaches that could undermine the important work that needs to take place.” 

Gigi Gronvall, senior scholar at the Johns Hopkins Center for Health Security, said that the “breathless hyping of risks” overshadows strong existing biosafety measures, such as U.S. efforts to train maximum containment labs abroad.

Asked which risks have been misunderstood, Gronvall said that “there is a lot of gray” and that the proper expertise is needed to interpret gain-of-function experiments, but did not go into further detail. 

Indeed, some experts called for decreased transparency for controversial research. Colorado State University Biosafety Rebecca Moritz called for limiting the scope of public records requests. U.S. Right to Know has submitted a public information request for records about the university’s research on bat coronaviruses in collaboration with EcoHealth Alliance, the U.S. Department of Defense (DoD) and the Defense Advanced Research Projects Agency.

The documents raise questions about the contagion risks, for example, of shipping of bats and rats infected with dangerous pathogens.

Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza, disputed the idea that research that contributes to vaccine development or results from surveillance should be included in the framework. 

Many representatives of the life science and biodefense fields emphasized weighing any regulation against lost opportunities for science. But members of the public who participated in the meeting were much more skeptical of the value of certain gain-of-function work.  

Alina Chan, a molecular biologist at the Broad Institute, said that the public should not be surprised by controversial gain-of-function experiments for the first time in scientific papers, long after the research has been approved and completed. 

Chan called for controversial experiments to be published on preprint servers and the genomes of novel viruses to be deposited into publicly available databases within a year of discovery.

She also called for greater transparency from private “virus hunting” organizations and middlemen between the NIH and labs, an apparent allusion to the EcoHealth Alliance and the Global Virome Project

Kevin Esvelt, a biologist at the Massachusetts Institute of Technology, said creating novel viruses in the lab, combined with the ease of synthesizing viruses from a genome sequence, poses a national security threat.

“More Americans have died of COVID than would perish if a Russian Topol SS-25 thermonuclear warhead were to be detonated in the center of Washington, DC,” said Esvelt. “Pandemic viruses can be more lethal than thermonuclear weapons. That makes them a proliferation concern.”

Institutional Biosafety Commmittee (IBC) Meeting Minutes

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U.S. Right to Know has obtained the following Institutional Biosafety Committee (IBC) meeting minutes though freedom of information requests.

IBCs review an institution’s protocols for working with potentially harmful biological agents, including pathogenic microorganisms, and provide biosafety recommendations for conducting the research. The IBC’s role is to review safety protocols; issue biosafety and protocol recommendations, including the appropriate biosafety level containment in which the research should be conducted; and assess risks to research personnel, the surrounding community, and to the public. USRTK collects and publishes IBC meeting minutes to increase the transparency of biohazard research and associated risks.

This page is a work in progress.  We will update it as we receive more IBC meeting minutes.

Rocky Mountain Laboratories (RML) IBC Meeting minutes
Batch #1 (12.30.21) (43 pages)

Washington State University (WSU) IBC Meeting minutes
Batch #4 (12.30.21) (149 pages)
Batch #3 (12.30.21) (160 pages)
Batch #2 (12.30.21) (127 pages)
Batch #1 (12.30.21) (111 pages)

University of California, Davis (UC Davis) IBC Meeting minutes
Batch #6  2017 (12.30.21) (86 pages)
Batch #5  2016 (12.30.21) (97 pages)
Batch #4   2015 (12.30.21) (102 pages)
Batch #3   2014 (12.30.21) (202 pages)
Batch #2   2013 (12.30.21) (110 pages)
Batch #1   2005 (12.30.21) (23 pages)

Wuhan’s lower biosafety level labs posed greater risk for coronavirus lab leak, experts said

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Biosafety experts, including one with longstanding ties to the Wuhan Institute of Virology (WIV), privately harbored questions about risks taken with coronavirus research at biosafety level 3 (BSL-3) labs, including those in Wuhan, according to emails obtained by U.S. Right to Know. The researchers felt that BSL-3 labs were more vulnerable to accidents, even more so than BSL-4 labs, a level used for the most potentially dangerous of pathogens.

While the WIV’s BSL-4 has been at the center of attention about biosafety practices related to the origin of Covid-19, the emails raise more questions about whether SARS-CoV-2 could have emerged from a lower biosafety level lab in Wuhan.

The emails cast doubt upon the biosafety protocols in place when the U.S. National Institutes of Health (NIH) funded EcoHealth Alliance (EHA), a U.S-based nonprofit research organization, to carry out research with the WIV and the University of North Carolina (UNC) that infected mice expressing human receptors with engineered novel bat coronaviruses. Much of that work on bat coronaviruses appears to have taken place in BSL-3 labs in Wuhan, according to grant documents submitted to the NIH; and in some cases, even lower containment BSL-2 labs in Wuhan, according to a Journal of Virology article, and other sources.

James Le Duc, a leading biosafety expert, and former director of the Galveston National Laboratory at the University of Texas Medical Branch (UTMB), and David Franz, a bioweapons expert and former commander of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), exchanged concerns about U.S. and Chinese BSL-2 and BSL-3 labs.

Le Duc has had significant contact with scientists in Wuhan over the years. He trained WIV scientists at the Galveston National Laboratory, and records show he made multiple trips to Wuhan since 1986 to train virologists there.

On May 15, 2021, after Franz shared a letter in Science in support of investigating the origins of Covid-19, including a possible lab origin, Le Duc wrote: “I’m afraid that it may be way too late to find much out but it should be attempted, including the bsl2 and bsl3 labs where I suspect the risk for accidental release is greater.”

On Jun 2, 2021, Le Duc wrote to Franz: “The focus on BSL4 is justified but the bigger problem is likely at BSL3 where many more exist and standards are varied.”

Franz wrote back to Le Duc, “I also mentioned the issue you raise about a focus on 4s, both because they tend to be taken more seriously by governments (possibly making them safer and more secure) than 2s or 3s and also that the 2s and 3s are generally more vulnerable than 4s.”

Biosafety level (BSL) designations were established in the mid-1970s. Biosafety labs are designated BSL-1 to BSL-4, with 4 as the most stringent in practices and containment of potential pathogens. In the U.S., the Centers for Disease Control and Prevention (CDC) and the NIH establish BSL designations. Pathogen Level [P] lab 1 to 4 designations are used interchangeably with BSL.

BSL-2 labs include ‘biosafety cabinets’ with HEPA filtration, where experiments are performed, providing lab researchers protection from infectious agents, according to the biosafety manuals of the CDC and Boston University. Personal protective equipment (PPE), including lab coats, gloves, and eye protection as well as decontaminating procedures, are standard. BSL-3 labs have additional biosafety measures, particularly to protect against agents with respiratory transmission routes; these include full gowns or Tyvek suits, face shields, and additional “risk-based” protections such as ventilation devices, which may differ depending on the agent being used. BSL-3 labs require negative pressure and a specialized anteroom, so that agents will be contained within the lab even in the case of an accidental spill or contamination; and have more extensive HEPA filtration systems.

BSL-4 facilities have been a focus of biosafety discussions because the most deadly and dangerous pathogens, such as Ebola and Marburg viruses, are studied there. BSL-4s have more custom-designed containment and stricter requirements, including “mandatory use of positive-pressure (“space”) suits” and “dedicated nonrecirculating ventilation systems.

In EHA-led work conducted in Wuhan, scientists infected humanized mice with engineered novel bat coronaviruses in a BSL-3 facility, according to grant documents EHA submitted to the NIH.  Some collection and engineering of bat coronaviruses were done in a BSL-2, with less stringent protocols and containment, according to multiple sources including a paper in the Journal of Virology .

“I think we need to remember that a lot of the work, especially on coronaviruses, has been done (presumably) at BSL3…”, wrote Le Duc.

In the NIH-funded EHA grant proposal, there was ambiguity as to where the humanized mouse infections would be performed. While many biosafety details were specified in the proposal for Ralph Baric’s UNC BSL-3 animal facility – such as “rodent-sized Seal-Safe systems (~192 cages) for maintaining animals in a Hepa-filtered Air in/out environment, exhausted into the BSL3 Hepa-filtered exhaust system” – few details were provided about biosafety measures for the animal work in Wuhan. EHA President Peter Daszak wrote to NIH staff in the summer of 2017, that “UNC has no oversight of the chimeric work, all of which will be conducted at the Wuhan Institute of Virology,” according to emails obtained by the White Coat Waste Project, a nonprofit watchdog group.

Confusingly, the infections of humanized mice with chimeric coronaviruses were said to be performed not only in Ralph Baric’s UNC animal BSL-3 lab, but at two locations in Wuhan – Wuhan University and the WIV. The animal BSL-3 labs at Wuhan University, were more sparsely described than those at the WIV, with general statements such as, experimental work using humanized mice will be conducted at the Center for Animal Experiment Biosafety 3 lab of Wuhan University at the School of Medicine in Wuhan, China…Animals will be housed in a BSL-3 facility and will be under the care of a full-time veterinarian.” More detailed descriptions of the animal protocols, however, were said to be available through the WIV or Wuhan University Institutional Animal Care and Use Committees (IACUC) .

Franz wrote to Le Duc: “I haven’t worried about the BSL-4 lab, but certainly the one downtown [in Wuhan].”

Earlier this year, the Global Times reported that, “Bai Chunli, president of the Chinese Academy of Sciences, said in April 2020 that China had two P4 labs in operation and 81 P3 labs in operation or approved for construction.”

Franz wrote, “There are also so many 2s and 3s that it is almost impossible to deal with them; it’s what happened with the legally binding protocol proposal to the BWC [Biological Weapons Convention] in the mid-90s.”

Le Duc wrote to Franz: “…the greatest risk is from the lower levels of biocontainment, but we don’t want to suggest that everything be moved to BSL4 either.”

U.S. Right to Know obtained the records reported on in this article through a Texas Public Information Act request to the University of Texas Medical Branch. We believe these records underscore the importance of transparency to minimize biosafety risks, prevent lab leaks and contain potential pandemic pathogens. They also highlight the need for scrutiny of current biosafety precautions.

Written by Sainath Suryanarayanan

Wuhan lab director ordered staff not to discuss Covid-19, State Department cable says, citing blogger

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The director of the Wuhan Institute of Virology (WIV) ordered staff in January 2020 to “not discuss COVID-19,” according to a Guangzhou-based blogger’s social media post that is cited in a February 2020 U.S. State Department cable obtained by U.S. Right to Know. The WIV is at the center of debate surrounding the origins of SARS-CoV-2, the novel coronavirus that causes Covid-19.

The cable, which states that the blogger’s post “has since been blocked on social media,” adds to reports of Chinese government gag orders surrounding information about Covid-19, including revelations that  Chinese Centers for Disease Control staff have been instructed not to share any information related to the new coronavirus with outside institutions or individuals.

The cable was among State Department records released in response to a U.S. Right to Know Freedom of Information Act lawsuit. Other items in the records include:

  • A February 2020 cable reported that the U.S. Consulate’s South China Public Affairs Section (PAS) “media contacts discussed the rumors circulating on social media that a graduate of the Wuhan Institute of Virology is patient zero of COVID-19, which has been denied by the Institute.” Media reports say the Wuhan Institute of Virology has denied links between WIV and patient zero, but the Biden administration has confirmed prior State Department’s claims that “several researchers inside the WIV became sick in autumn 2019… with symptoms consistent with both COVID-19 and common seasonal illnesses.”
  • A March 2020 cable analyzed the Chinese government and affiliated media’s messaging on Covid-19.
  • Cables from August and October 2020 show the quasi-governmental role played by EcoHealth Alliance in Malaysia as an “implementing partner” of the U.S. Agency for International Development’s PREDICT program. EcoHealth Alliance is a New York-based nonprofit that has received millions of dollars of U.S. taxpayer funding for projects, which include genetically  manipulating coronaviruses with scientists at WIV.

For more information

U.S. State Department records, which U.S. Right to Know obtained through ongoing FOIA litigation, can be found here: State Department Batch #4 (129 pages)

Background page on U.S. Right to Know’s investigation into the origins of SARS-CoV-2.

Written by Sainath Suryanarayanan

Colorado State University documents on bat pathogen research

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This post describes documents of Colorado State University (CSU) Professors Rebekah Kading and Tony Schountz, which U.S. Right to Know obtained from a public records request. Kading and Schountz are virologists who study bat-associated pathogens in hot-spots across the world. They collaborate with EcoHealth Alliance, the U.S. Department of Defense (DoD) and the Defense Advanced Research Projects Agency (DARPA), the U.S. military’s research and development arm.

The documents offer a glimpse into the military-academic complex of scientists who study how to prevent spillovers of potential pandemic pathogens from bats. The documents raise questions about contagion risks, for example, of shipping of bats and rats infected with dangerous pathogens. They also contain other noteworthy items, including:

  1. In February 2017, DoD coordinators of the Defense Threat Reduction Agency’s Cooperative Biological Engagement Program announced a new global bat alliance “to build and leverage country and regional capabilities to generate an enhanced understanding of bats and their ecology within the context of pathogens of security concern.” Associated with this, the emails show a collaboration between CSU, EcoHealth Alliance and the National Institutes of Health’s Rocky Mountain Laboratories to build a bat research site at CSU to expand bat infection studies.
  2. The global bat alliance evolved into a group called Bat One Health Research Network (BOHRN). By 2018, key BOHRN scientists were working with DARPA on a project called PREEMPT. CSU records on PREEMPT show that Rocky Mountain Laboratories, CSU and Montana State University are developing “scalable vectored” vaccines to spread through bat populations “to prevent emergence and spillover” of potential pandemic viruses from bats to human populations. Their goal is to develop “self-disseminating vaccines” — which spread contagiously between bats — in hopes of eliminating pathogens in their animal reservoirs before spillover into humans. This research raises concerns about unintended consequences of releasing genetically engineered self-spreading entities into the open, and the ecological risks of their unknown evolution, virulence and spread.
  3. Shipping bats and rats infected with dangerous pathogens creates the potential for unintended spillover into humans. Tony Schountz wrote to EcoHealth Alliance VP Jonathan Epstein on March 30, 2020: “RML [Rocky Mountain Labs] imported the Lassa virus reservoir by having them born in captivity in Africa, then the offspring were imported directly to RML. Don’t know if horseshoe bats can be born in captivity, but that could be an avenue to alleviate CDC concerns.” Lassa virus is spread by rats that are endemic to west Africa. It causes an acute illness called Lassa fever in humans, which leads to an estimated 5,000 deaths every year (1% death rate).
  4. On February 10, 2020, EcoHealth Alliance President Peter Daszak sent an email soliciting signatories for a draft of The Lancet statement “to strongly condemn conspiracy theories suggesting that 2019-nCoV does not have a natural origin.” In the email, Daszak wrote: “Drs. Linda Saif, Jim Hughes, Rita Colwell, William Karesh and Hume Field have drafted a simple statement of support for scientists, public health and medical professionals of China fighting this outbreak (attached), and we invite you to join us as the first signatories.” He did not mention his own involvement in drafting the statement.  Our prior reporting showed that Daszak drafted the statement that was published in The Lancet.
  5. Tony Schountz exchanged emails with key Wuhan Institute of Virology (WIV) scientists Peng Zhou, Zhengli Shi and Ben Hu. In an email dated October 30, 2018, Schountz proposed to Zhengli Shi a “loose association” between CSU’s Arthropod-borne and Infectious Disease Laboratory and WIV, involving “collaboration on relevant projects (e.g., arboviruses and bat-borne viruses) and training of students.” Zhengli Shi responded positively to Schountz’s suggestion. The records do not suggest that any such collaboration was initiated.

For more information

A link to the entire batch of Colorado State University documents can be found here: CSU records

U.S. Right to Know is posting documents obtained through public freedom of information (FOI) requests for our Biohazards investigation in our post: FOI documents on origins of SARS-CoV-2, hazards of gain-of-function research and biosafety labs.

Written by Sainath Suryanarayanan