The National Institutes of Health said Wednesday that a nonprofit group that was shot at by some Republicans in Congress for its research collaborations in China had failed to promptly report results from studies on how well bat coronavirus grow in mice.
In a letter to Rep. James Comer, Republican of Kentucky, the N.I.H. said the group, EcoHealth Alliance, had five days to submit any unpublished data from work done under a multi-year grant it received in 2014 for research. The organization's grant was canceled in 2020 under the administration of President Donald J. Trump during his feud with China over the origins of the coronavirus.
In the past few months, N.I.H. Officials have denied claims – sometimes in heated conversations with Republicans in Congress – that coronaviruses studied with federal funds could have caused the pandemic. Dr. Francis Collins, the director of the N.I.H., issued a statement on Wednesday evening in which he reiterated this rebuttal.
"Naturally occurring bat coronaviruses, which are part of the N.I.H. Grants are genetically far removed from SARS-CoV-2 and cannot possibly have caused the Covid-19 pandemic, "he said in the statement. "Other claims are proven to be false."
The EcoHealth Alliance has come under scrutiny due to its coronavirus research collaboration with researchers from the Wuhan Institute of Virology in the city where the pandemic began.
Robert Kessler, a spokesman for the group, said Thursday that the EcoHealth Alliance is trying to work with the N.I.H. He said the group reported data from their studies in April 2018 "as soon as we became aware of it" and that the agency reviewed the data and never indicated that further reviews were needed.
Some scientists have argued that SARS-CoV-2 may have been the result of genetic engineering experiments or simply escaped from a laboratory in an accident. But direct evidence for these theories is still pending. Others considered these scenarios unlikely and instead pointed to a lot of evidence suggesting humans acquired the coronavirus in a natural overflow from bats or an intermediate mammalian host.
The controversy has the experiments carried out by the EcoHealth Alliance and the Wuhan Institute of Virology with funds from the N.I.H.
Last month, The Intercept, an online publication, released 900 pages of materials on the N.I.H. Grants to the EcoHealth Alliance for research. The materials included details of experiments designed to provide new insights into the risk of bat coronavirus in triggering new pandemics.
In some of their experiments, the researchers isolated genes from bat coronaviruses that encode a surface protein called spike. Coronaviruses use the spike protein to attach to host cells, the first step towards infection. The spike protein binds to a cell surface protein called ACE2.
According to the published materials, the researchers then developed another bat virus called WIV1 to carry spike proteins from other bat coronaviruses. They then carried out experiments to see whether the engineered WIV1 viruses could bind better to ACE2 on cells.
Such experiments sparked a longstanding debate about what kind of research is simply too dangerous, regardless of the evidence it may provide. Experiments that can add new capabilities to viruses – sometimes referred to as "functionality enhancements" – have been of particular concern.
In 2017, the Department of Health and Human Services introduced the “P3CO framework” for research into “expanded potential pandemic pathogens”.
Dr. Lawrence Tabak, the chief deputy director of the NIH, wrote in the letter to Representative Comer that the agency had determined that the research proposed by the EcoHealth Alliance did not meet the criteria for additional review under this framework, "because this is bat coronavirus were not available ”. verifiably infect humans. "
But "out of caution," wrote Dr. Tobacco, the agency added requirements for the EcoHealth Alliance to inform them of certain results of the experiments.
Dr. Tobacco noted that on one line of research, the researchers created mice that were genetically engineered to produce the human version of the ACE2 protein on their cells. Infecting these animals with coronaviruses could potentially give a more realistic sense of the risk the viruses have of infecting humans than just using cells with cells.
The N.I.H. requested that the EcoHealth Alliance notify the agency if the genetically engineered viruses were found to grow ten times faster or more than WIV1 without their new spike proteins.
In some experiments it was found that viruses grew rapidly.
"EcoHealth did not report this finding immediately, as the funding conditions prescribe," wrote Dr. Tobacco.
The N.I.H. also sent Representative Comer a final progress report that the EcoHealth Alliance had submitted to the agency in August.
In the report, the researchers describe that WIV1 coronaviruses engineered to carry spike proteins were more virulent. They killed infected mice at higher rates than the WIV1 virus without spikes from the other coronaviruses.
The application was filed late, the N.I.H. said nearly two years past the 120 day funding period after the work was completed. "Late reporting is a violation of the N.I.H. Terms and Conditions. Sponsorship award ”, said Renate Myles, spokeswoman for the agency.
Jesse Bloom, a virologist at the Fred Hutchinson Cancer Center who has called for more research into the origins of the pandemic, said the revelations raise serious questions about the risks of studying viruses derived from animals known as zoonotic viruses.
"I believe that some of this research into potential pandemic pathogens carries unacceptable risks," he said. "In addition to the question of whether EcoHealth has complied with the current regulations, we must honestly ask ourselves what research should be carried out in the future in order to best minimize both zoonotic and laboratory-related pandemic risks."
And Michael Imperiale, a virologist at the University of Michigan, said the N.I.H. Brief raised questions about how the agency assessed potentially dangerous research and shared it with the public – a necessity that critics have been pointing out for years. “First and foremost, I think that this is the need for transparency in the way the N.I.H. review these experiments, ”he said.
Some Republicans in Congress have been pushing for more information for months, suggesting the research was the source of the pandemic. In a statement, MP Comer claimed that "thanks to the hard work of the Republicans on the Oversight Committee, we now know that American taxpayers' money has funded research into the profitability of the Wuhan laboratory."
The letter from Dr. Tobacco made no mention of "gain in function" research.
MP Comer also accused Dr. Collins and Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, alleged to have misled the committee and swore that the G.O.P. Panel "will leave no stone unturned as we seek the truth for the American people about how their tax dollars may have been linked to the start of this pandemic."
Ms. Myles rejected the claim that EcoHealth's experiments represented gain-of-function research. She admitted that the results in mice were "a little unexpected". However, Ms. Myles said the agency had reviewed the research described in EcoHealth's progress report and said it had not triggered a review under the stricter protocols for P3CO studies.
"The bat coronaviruses used in this research do not infect humans, and the experiments were not reasonably expected to increase transmissibility or virulence in humans," she said.
Mr Kessler, the spokesman for EcoHealth, said none of the coronaviruses studied by the group were genetically similar enough to the virus behind Covid-19 to have played a role at the start of the pandemic.
On a website published Wednesday evening, the National Institutes of Health provided additional details about the viruses in the EcoHealth experiments and showed that they were not closely related to SARS-CoV-2.
Bats harbor thousands of species of coronavirus, and since the pandemic began, researchers have been looking for the closest relatives of SARS-CoV-2 to infecting the animals. They found several coronaviruses that are much more closely related to SARS-CoV-2 than WIV1.
The analysis, wrote Dr. Tobacco in his letter, "confirms that the bat coronaviruses examined as part of the EcoHealth Alliance grant could not have been the source of SARS-CoV-2 and the Covid-19 pandemic."