Ecohealth Alliance Statement in Response to Report 23-106119 of the U.S. Government Accountability Office: “Federal Research: NIH Could Take Additional Actions to Manage Risks Involving Foreign Subrecipients” 

JUNE 15, 2023 – EcoHealth Alliance welcomes the study conducted by the U.S. Government Accountability Office (GAO) of activities and disbursements related to funding via subawards to Wuhan University and the Wuhan Institute of Virology from grants made by the U.S. National Institutes of Health (NIH) and the U.S. Agency for International Development (USAID) to EcoHealth Alliance and the University of California, Davis, during calendar years 2014 – 2021 (Report 23-106119, https://www.gao.gov/products/gao-23-106119). EcoHealth Alliance cooperated fully and transparently with the GAO’s inquiries. 

The GAO study identified subaward funding to the Wuhan University (WU) and Wuhan Institute of Virology (WIV), reviewed risk assessments conducted by the NIH and USAID before awarding funding, and the purpose and results of subaward funding. GAO confirmed that subgrants made to WIV by EcoHealth Alliance amounted to less than $142K annually over 8 years from 2014 – 2021.

EcoHealth Alliance notes the following findings from the GAO audit report:

GAO confirms that “In the July 2016 letter, the NIAID officials stated they had reexamined EcoHealth Alliance’s original grant application and supplemental information and determined that the research to generate MERS-like or SARS-like chimeric coronaviruses was not subject to the gain-of-function research funding pause…(Appendix II, p.33)”

GAO also confirms that EHA’s research collaboration with the Wuhan Institute of Virology could not have been the source of the SARS-CoV-2 coronavirus and the COVID-19 pandemic disease. The report specifies as follows: “NIH had analyzed the experiments funded in 2014 through 2018 under the grant and determined that the naturally occurring coronaviruses included in the study could not have been the source of the SARS-CoV-2 coronavirus and the COVID-19 pandemic disease, and research conducted under the award did not fit the definition of research involving enhanced pathogens of pandemic potential because the viruses being studied by WIV under the subaward from EcoHealth Alliance had not been shown to infect humans. (Appendix II, p.34-35)”

GAO explores the inaccurate contention of the then NIH Deputy Principal Director that “EcoHealth Alliance violated an award condition when it failed to immediately report experimental results to NIH showing that laboratory mice became sicker from one of the bat coronaviruses under experiment at WIV compared to a control cohort of mice and EcoHealth Alliance notified NIH of the experimental results in August 2021, at which point the agency informed EcoHealth Alliance that it had 5 days to submit any unpublished data from the WIV experiments. (Appendix II, p.34)” This statement was based on a mischaracterization of what EHA’s experiments actually showed. In fact, EcoHealth Alliance did not violate the award conditions. EHA reported the results of the mouse experiment in question to the NIH in April 2018 in our Year 4 report. Furthermore, EHA conducted no further experiments on these viruses, which, it is important to note, were based on a WIV1 backbone and dealt with a MERS-like virus, not SARS-CoV (i.e., the work was with a bat CoV spike in a bat CoV backbone, which had never been shown to infect people).  But, most importantly, there was no real evidence of enhanced viral growth in this experiment. The growth in viral genome copies/gram that EHA reported was transient, found only at days 2 and 4 post infection, and returned to almost identical to the backbone virus (WIV-1) by day 6, and lower than baseline by the end of the experiment. The results were from small numbers of mice and were therefore not statistically significant (they could have resulted from variation in individual mice before infection). Oversight of the experiments was in keeping with the conditions of the grant award. The NIH did not respond with any comments to EHA’s report, which suggests that they agreed at the time – it was only more than two years later, in hindsight, that they raised questions about this experiment – and started from the mistaken assumption that EHA’s report showed a real instance of enhanced viral growth. 

The GAO report also explores the issue of the timing of EcoHealth Alliance’s report, and reports that NIH said that “… [EcoHealth Alliance] notified the NIH of the experimental results in August 2021”. This is not correct. EcoHealth Alliance provided the GAO with documentation regarding this alleged late reporting that showed the experimental results were first reported in the Year 4 report, which was submitted into the NIH system on time in April 2018, with a copy emailed to the NIAID Program Officer at that time. The Year 5 report was uploaded into the NIH system, but then locked out from full submission and NIH did not respond to requests from EcoHealth staff to enable full submission. However, NIH program staff were made aware of the results of the experiments because these were fully laid out in the “preliminary data” sections of the renewal proposal submitted in November 2018.

EcoHealth Alliance also provided information to the GAO demonstrating that all three of the subawards in question resulted in publications and information sharing (See GAO Report, Figure 5, page 13). These included sharing 1) annual progress reports to NIH; 2) scientific presentations at numerous academic society meetings and to the US National Academies; 3) briefings and meetings with members of diverse government agencies, including USAID, DoD DTRA, OSTP, the White House Assistant Secretary for Pandemic Preparedness, intelligence agencies, DHS and others; and, importantly 4) by publishing results in a large number of peer-reviewed papers including those listed below:

  1. Li, X. et al. A Novel Potentially Recombinant Rodent Coronavirus with a Polybasic Cleavage Site in the Spike Protein. Journal of Virology 95, e01173-01121, doi:10.1128/JVI.01173-21 (2021).
  2. Li, H. et al. Wild animal and zoonotic disease risk management and regulation in China: Examining gaps and One Health opportunities in scope, mandates, and monitoring systems. One Health 13, 100301, doi:https://doi.org/10.1016/j.onehlt.2021.100301 (2021).
  3. Li, H.-Y. et al. A qualitative study of zoonotic risk factors among rural communities in southern China. International Health 12, 77-85, doi:10.1093/inthealth/ihaa001 (2020).
  4. Latinne, A. et al. Origin and cross-species transmission of bat coronaviruses in China. Nature Communications 11, 4235, doi:10.1038/s41467-020-17687-3 (2020).
  5. Li, H. et al. Human-animal interactions and bat coronavirus spillover potential among rural residents in Southern China. Biosafety and Health 1, 84-90, doi:https://doi.org/10.1016/j.bsheal.2019.10.004 (2019).
  6. Zhou, P. et al. Fatal Swine Acute Diarrhea Syndrome caused by an HKU2-related Coronavirus of Bat Origin. Nature 56, 255-258, doi: 10.1038/s41586-018-0010-9 (2018).
  7. Wang, N. et al. Serological evidence of bat SARS-related coronavirus infection in humans, China. Virologica Sinica 33, 104-107, doi:10.1007/s12250-018-0012-7 (2018).
  8. Hu, B. et al. Discovery of a rich gene pool of bat SARS-related coronaviruses provides new insights into the origin of SARS coronavirus. PLoS pathogens 13, doi:10.1371/journal.ppat.1006698 (2017).
  9. Zeng, L. P. et al. Bat Severe Acute Respiratory Syndrome-Like Coronavirus WIV1 Encodes an Extra Accessory Protein, ORFX, Involved in Modulation of the Host Immune Response. Journal of Virology 90, 6573-6582, doi:10.1128/jvi.03079-15 (2016).
  10. Yang, X. L. et al. Isolation and Characterization of a Novel Bat Coronavirus Closely Related to the Direct Progenitor of Severe Acute Respiratory Syndrome Coronavirus. Journal of Virology 90, 3253-3256, doi:10.1128/jvi.02582-15 (2016).
  11. Hu, B. et al. Detection of diverse novel astroviruses from small mammals in China. Journal of General Virology 95, 2442-2449, doi:10.1099/vir.0.067686-0 (2014).
  12. Ge, X. Y. et al. Isolation and characterization of a bat SARS-like coronavirus that uses the ACE2 receptor. Nature 503, 535-+, doi:10.1038/nature12711 (2013).

Press contact: communications@ecohealthalliance.org

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