Republicans Spin NIH Letter About Coronavirus Gain-of-Function Research
Research, which the NIH maintains is not gain-of-function, could not have led to SARS-CoV-2, the virus that causes COVID-19.
REPUBLICANS SAY A LETTER FROM A NATIONAL INSTITUTES OF HEALTH official is an admission that the agency funded so-called gain-of-function research on bat coronaviruses in China, with some falsely linking the work to the pandemic coronavirus. But the research, which the NIH maintains is not gain-of-function, could not have led to SARS-CoV-2, the virus that causes COVID-19.
On Oct. 20, the Republican staff of the House Oversight and Reform Committee released a letter from NIH Principal Deputy Director Lawrence A. Tabak responding to an inquiry about a grant awarded to EcoHealth Alliance, a U.S.-based scientific nonprofit focused on pandemic prevention and conservation.
The grant, which was awarded in 2014 and was canceled in April 2020, has been the subject of much controversy. It assessed the potential for bat coronaviruses in China to spillover and infect people and included some experiments mixing and matching elements of different viruses to better understand them. It also involved a collaboration with scientists at the Wuhan Institute of Virology.
In the letter, Tabak said EcoHealth Alliance had violated the terms of its grant by not immediately reporting an unexpected experimental result in which mice became sicker when infected with a modified coronavirus.
Republicans were quick to interpret the letter as an admission that the agency had funded gain-of-function research.
In commentary accompanying the shared letter, the committee said on Twitter that the NIH “confirmed today EcoHealth and the WIV conducted GOF research on bat coronaviruses” and that NIH was “lied to” by EcoHealth.
As we’ll explain, whether or not the experiments count as “gain-of-function” — research in which a virus or other pathogen is modified to become more virulent or infectious to humans — is up for debate.
The NIH has said they do not qualify under its criteria and reiterated that position after the release of Tabak’s letter; other experts have expressed a range of views. There is no evidence that Fauci knowingly gave false information or misled anyone.
Some Republicans, however, went further, using the letter to falsely link the NIH-funded research to the COVID-19 pandemic. In an Oct. 21 interview on Fox’s Ingraham Angle, Rep. James Comer of Kentucky, the ranking member of the committee, erroneously said that the NIH letter “proves all along that this virus was started in the Wuhan lab.”
The letter does not prove that. In fact, it goes to great lengths to explicitly state the opposite, noting that the viruses used in the experiments are “decades removed from SARS-CoV-2 evolutionarily” and that they “could not have been the source of SARS-CoV-2.”
Previously, other Republicans, including Florida Rep. Matt Gaetz and Sen. Rand Paul of Kentucky, have at times falsely insinuated that the work could have led to the creation of SARS-CoV-2. Paul got into a heated debate with Fauci in July when both men accused the other of lying.
The falsely suggestive hashtag #FauciLiedPeopleDied also started to appear on Twitter after the letter was posted on the platform.
No Connection to the Pandemic Virus
The EcoHealth Alliance experiments have nothing to do with the COVID-19 pandemic and did not produce SARS-CoV-2, the NIH says.
“Analysis of published genomic data and other documents from the grantee demonstrate that the naturally occurring bat coronaviruses studied under the NIH grant are genetically far distant from SARS-CoV-2 and could not possibly have caused the COVID-19 pandemic,” NIH Director Dr. Francis Collins said in an Oct. 20 statement, referring to an analysis posted to the NIAID’s website. “Any claims to the contrary are demonstrably false.”
The analysis shows that the viruses used in the EcoHealth Alliance experiments share only around 80% of their genomes with SARS-CoV-2 — a huge difference when making these comparisons.
Much more similar viruses that share 96% to 97% of their genomes with SARS-CoV-2 have been identified. These include BANAL-52, a bat coronavirus found in Laos and reported in September, and RaTG13, a virus sequence collected by the Wuhan Institute of Virology that has also been the subject of much misplaced speculation.
But even these, the analysis explains, are still much too dissimilar to have given rise to SARS-CoV-2.
Setting aside the specific experiments performed with the grant funds, there is no evidence SARS-CoV-2 came from a lab, and many experts say that it’s virtually impossible for it to have been engineered.
The NIH Letter
In the letter, Tabak describes an alleged grant reporting infraction related to an experiment the agency said was conducted in 2018-2019 and related in a progress report EcoHealth submitted in August 2021.
The experiment, Tabak said, tested whether spike proteins from bat coronaviruses were capable of binding to human ACE2, the receptor that the viruses use to enter cells, in mice.
The experiment is similar to research published in PLOS Pathogens in 2017, which studied two of the same modified viruses. In that paper, researchers used the backbone of WIV1, a bat SARS-like virus reported in 2013, and swapped in the spike proteins of two newly identified bat coronaviruses to see if they, like WIV1, could use the ACE2 receptor to enter human cells grown in a petri dish. They could.
This time, the researchers did a similar experiment, but tested the chimeric viruses in mice. Since mice have their own ACE2 receptor, the animals were engineered to express the human form, but were otherwise unchanged.
“In this limited experiment, laboratory mice infected with the SHC014 WIV1 bat coronavirus became sicker than those infected with the WIV1 bat coronavirus,” Tabak wrote. “As sometimes occurs in science, this was an unexpected result of the research, as opposed to something that the researchers set out to do.”
As is shown in section 3.1 of the grant progress report, which was provided to and released by the Republicans on the House committee, infection with the viruses killed some of the mice, with the one chimeric virus being especially lethal. That virus killed six of the eight mice, replicated better than WIV1 in various mouse tissues and caused more pathology in the lung.
Tabak said in his letter that the research plan had been reviewed by the agency before funding, and the agency determined that it did not meet the NIH’s definition of gain-of-function — or what the agency terms research involving enhanced pathogens of pandemic potential — “because these bat coronaviruses had not been shown to infect humans.” It therefore was not subject to review under the Department of Health and Human Services’ framework for enhanced pathogens.
But, he added, “out of an abundance of caution and as an additional layer of oversight,” the agency had outlined criteria in the terms and conditions of the grant award for a secondary review, “such as a requirement that the grantee report immediately a one log increase in growth,” meaning a 10-fold increase in viral growth, to “determine whether the research aims should be re-evaluated or new biosafety measures should be enacted.”
“EcoHealth failed to report this finding right away, as was required by the terms of the grant,” the letter reads. “EcoHealth is being notified that they have five days from today to submit to NIH any and all unpublished data from the experiments and work conducted under this award.”
Tabak then spent the bulk of the letter’s second page explaining that bat coronaviruses used in the experiments “could not have been the source of SARS-CoV-2 and the COVID-19 pandemic,” as we’ve established.
For its part, EcoHealth disputes NIH’s characterization.
“EcoHealth Alliance is working with the NIH to promptly address what we believe to be a misconception about the grant’s reporting requirements and what the data from our research showed,” said Robert Kessler, the group’s spokesperson, in a statement provided to FactCheck.org. “These data were reported as soon as we were made aware, in our year 4 report in April 2018. NIH reviewed those data and did not indicate that secondary review of our research was required, in fact year 5 funding was allowed to progress without delay.”
The progress report notes that its experiments in mice were “continued” in year 5.
In his statement, Kessler confirmed that the organization’s grant was not ongoing. Collins similarly told CNN that the grant had been suspended “since last year.”
Although Tabak does not say in his letter that the EcoHealth experiment in question was gain-of-function, numerous Republicans interpreted it to be such an admission.
As we’ve written, gain-of-function can refer to a lot of scientific experiments that aim to add a function to a virus or organism that is entirely benign, such as making a viral stock easier to grow to better increase the yield for a vaccine. What is controversial is research that could make viruses or other infectious microbes more dangerous, either by increasing their transmissibility or virulence.
Some people have argued that very little or none of this research should be allowed because it is too risky, while others say the work needs to be done to better prepare for events such as pandemics.
Recognizing the debate, the U.S. government instituted a pause in 2014 on new funding for research that “may be reasonably anticipated” to enhance the transmissibility or virulence of influenza, MERS, or SARS viruses. Three years later, the government lifted the moratorium and unveiled a new framework for making funding decisions for these types of projects on a case-by-case basis.
The framework pertains to funding decisions on “proposed research that is reasonably anticipated to create, transfer, or use” what it calls “enhanced potential pandemic pathogens,” or ePPPs. A potential pandemic pathogen, or PPP, is one that is both “likely highly transmissible and likely capable of wide and uncontrollable spread in human populations” and “likely highly virulent and likely to cause significant morbidity and/or mortality in humans.” An ePPP is a PPP “resulting from the enhancement of the transmissibility and/or virulence of a pathogen.” Even if a virus has the potential to spark a pandemic, it would not be considered “enhanced” if it is found in nature.
This formal definition differs in a few possible respects from what is described in the grant progress report — namely, that the research would need to be expected to produce an ePPP and that the virus in question would have to be “likely highly” virulent and transmissible, specifically in humans.
The NIH argues that the EcoHealth Alliance experiments, although they produced a more virulent virus in mice, did not meet that definition.
“The bat coronaviruses used in this research have not been shown to infect humans, and the experiments were not reasonably expected to increase transmissibility or virulence in humans,” an NIH spokesperson told the New York Times following the release of the letter, adding that the experiments would not have triggered a review.
The NIH says it has only ever green-lighted three projects under its ePPP framework.
It’s worth noting that, as before with their 2017 experiments, the researchers were working with WIV1, a virus that already had the ability to bind to human ACE2, so swapping in spike proteins from other viruses was aimed at replacing a function, not giving the virus a new ability, as King’s College London virologist Stuart Neil has pointed out before.
The NIH also explains on its website that WIV1 “is not known to cause infection in humans but has been shown in the laboratory to infect both human cells and ACE2 transgenic mice, making it an ideal tool to use for these studies.”
We reached out to the NIH for more information but did not receive a reply.
Other experts disagree. Richard Ebright, a professor of chemistry and chemical biology at Rutgers University who is a vocal critic of gain-of-function research, sided with Republicans about the interpretation of the letter. “NIH corrects untruthful assertions by NIH Director Collins and NIAID Director Fauci that NIH had not funded gain-of-function research in Wuhan,” he wrote on Twitter.
Multiple other experts told the Intercept, which published other similar documents last month after suing the NIH, that the work EcoHealth Alliance was doing would be considered gain-of-function, although one said it wasn’t problematic.
Angela Rasmussen, a virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization, told the Intercept that the research clearly was not gain-of-function because it’s not possible to conclude the viruses would be harmful to humans. “You can’t predict that these viruses would be more pathogenic, or even pathogenic at all in people,” she said. “They also did not study transmissibility.”
Still other experts say regardless of the technical definition of gain-of-function, the research described in the progress report strikes them as too risky and raises concerns about the NIH review process.
Fauci has defended himself, responding in an Oct. 24 ABC News interview to claims from Sen. Paul that he “lied” by saying that neither he nor Collins “lied or misled” anyone because he was operating under the framework. “There are people who interpret it that way,” he said, referring to those who view the work as gain-of-function, “but when you look at the framework under which the guidance is, that is not the case.”
Rasmussen said that the committee’s tweet was “wrong” since the letter “clearly states that this wasn’t GOF by the P3CO definition, which for NIH-funded work is the relevant standard,” referring to gain-of-function and the policy framework for handling such research.
But she also criticized EcoHealth, saying the “lack of transparency & failure to comply with NIH requirements is indefensible.”
Collins pinned blame on EcoHealth as well.
“They messed up here. There’s going to be some consequences for EcoHealth,” he told the Washington Post in an interview.
But he also acknowledged that this new information did not mean anything that happened was risky. Had the group reported its result earlier, he said, “it would not have been a reason to sort of hit the panic button and say my god this is dangerous stuff.”
“In this one instance, they failed to report the results of an experiment that they should have told us about immediately,” Collins also said of EcoHealth Alliance in an interview with CNN. “This is not a circumstance where I think you could say there was a major failure that put human lives at risk.”
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