The United States Department of Health and Human Services has suspended funding to the WIV following a recently released report
The United States Department of Health and Human Services has suspended funding to the WIV following a recently released report
HHS suspends and proposes debarment of WIV from participating in US Federal Government procurement and non-procurement program
Let’s travel back in time, and see where this all began.
It’s currently May 27, 2014.
The NIH, NIAID awarded Grant Number 1R01AI110964-01, "Understanding the Risk of Bat Coronavirus Emergence," to EcoHealth, with a project period from June 1, 2014 through May 31, 2019.
The EcoHealth is a United States-based nonprofit organization that focuses on research that aims to prevent pandemics and promote conservation in hotspot regions worldwide. The stated mission of EcoHealth is protecting people, animals, and the environment from emerging infectious diseases.
WIV, located in Wuhan, China, was listed as a consortium participant in the No for Grant Number 1R01AI110964-01. As stated in the NIH GPS, the prime recipient is accountable to the NIH for the performance of the project, the appropriate expenditure of grant funds by all parties, applicable reporting requirements, and all other obligations of the recipient. In addition, the terms and conditions flow down to subrecipients in accordance with 2 C.F.R. Part 200.101(b)(2).
Grant Number 1R01AI110964-01 involved the study of highly pathogenic agents, which required the grant prime awardee's (EcoHealth's) and sub-recipient’s (WIV's) adherence to specific safety (biosafety) requirements; this was a term of the award. This grant was subject to biosafety requirements set forth in the NIH GPS, a term and condition of every NIH grant award, Section 4.1.24 "Public Health Security" and the Notice of Award, Section IV (e.g., requiring that "Research funded under this grant must adhere to the [CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)1)."
On October 17, 2014, the White House announced that the United States Federal Government was instituting a governmentwide funding pause on gain-of-function (GoF research projects that may be reasonably anticipated to confer attributes to influenza, Middle East respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS) viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route.
This next piece of the puzzle is what really starts to grab your attention
In a letter dated May 28, 2016, NIAID contacted EcoHealth concerning possible GoF research based on information submitted in its most recent Year 2 RPPR. NIAID notified EcoHealth that GoF research conducted under Grant Number SR01AI1 10964-03 would be subject to the October 17, 2014, United States Federal Government funding pause, and that per the funding pause announcement, new United States Federal Government funding would not be released for GoF research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route.
In the letter, NIAID requested that EcoHealth provide a determination within 15 days of the date of the letter as to whether EcoHealth's research under Grant Number 5R01AI110964-03 did or did not include GoF work subject to the funding pause.
In a letter dated June 8, 2016, EcoHealth provided a response to NIAID's May 28, 2016 letter. EcoHealth explained that the goal of its proposed work was to construct MERS and MERS-like chimeric CoVs in order to understand the potential origins of MERS-CoV in bats by studying bat MERS-like CoVs in detail.
EcoHealth stated that it believed it was highly unlikely that the proposed work would have any pathogenic potential, but that should any of these recombinants show evidence of enhanced virus growth greater than certain specified benchmarks involving log growth increases, or grow more efficiently in human airway epithelial cells, EcoHealth would immediately:
stop all experiments with the mutant
inform the NIAID Program Officer of these results,
participate in decision-making trees to decide appropriate paths forward.
Based on the information provided by EcoHealth, NIAID concluded that the proposed work was not subject to the GoF research pause. In a letter dated July 7, 2016, however, NIAID informed EcoHealth that should any of the MERS-like or SARS-like chimeras generated under the grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain, EcoHealth must stop all experiments with these viruses and provide NIAID Program Officer and Grants Management Specialist, and WIV Institutional Biosafety Committee, with the relevant data and information related to these unanticipated outcomes.
Now... so that I do not bore you to death, I will jump forward in time, closer to where we are today to show what caused the suspension and debarment of the WIV as we now await further investigation into Fauci to continue.
On November 5, 2018, the NIH received a renewal application from EcoHealth (Type 2), and on April 23, 2019, the NIH approved the application for funding.
On July 24, 2019, a No was issued for Grant Number 2R01AI110964-06, with a project period from June 1, 2014 through June 30, 2024. The proposed work in the renewal application for Grant Number 2R01AI110964-06 was to investigate more divergent animal viruses, and NIAID determined that the HHS P3CO policies did not apply to the work proposed under the competitive renewal application.
Accordingly, the special term and condition cited to above in paragraph 11 was applicable to the grant as revised in R01AI110964-03 through the grant renewal period corresponding to SR01AI110964-05. After processing the grant renewal 2R01AI110964-06, the NIH performed routine grant administration activities and monitoring.
In a letter dated April 19, 2020, the NIH notified EcoHealth that it was reviewing allegations that WIV released the coronavirus that was responsible for the COVID-19 global pandemic. While it reviewed the allegations, the NIH instructed EcoHealth to cease providing any funds from Grant Number R01AI110964 to WIV.
In a letter dated April 24, 2020, the NIH notified EcoHealth that it had elected to terminate Grant Number R01AI110964, for convenience.
In a letter dated May 22, 2020, the law firm [Redacted] representing EcoHealth, notified the NIH that it was appealing the termination of Grant Number R01AI110964.
In a letter dated July 8, 2020, the NIH notified EcoHealth that it withdrew its termination of Grant Number R01 AI1 10964, and reinstated the grant.
The NIH stated that it had received reports that WIV had been conducting research at its facilities in China that posed serious biosafety concerns and, as a result, created health and welfare threats to the public in China and other countries, including the United States. The letter stated that during the period of programmatic suspension, the NIH would continue to review the activities under the grant, taking into consideration information provided by EcoHealth to further assess compliance by EcoHealth and WIV.
Among the information and materials requested by NIH from EcoHealth, NIH also directed EcoHealth to arrange for WIV to submit to an outside inspection team charged to review the lab facilities and lab records, with specific attention to addressing the question of whether WIV staff had SARS-CoV-2 in their possession prior to December 2019.
The NIH also informed EcoHealth that it was delinquent in the submission of the Year 5 I-RPPR, for the reporting period from June 1, 2018 to May 31, 2019. The report was due to be submitted within 120 days after the end of the project period, which was September 30, 2019. The NIH requested that EcoHealth provide the remaining documents and outstanding reports by August 27, 2021.
On August 3, 2021, EcoHealth submitted the Year 5 I-RPPR for Grant Number 5R01AI110964-05. The NIH's review determined that an experiment, had possibly yielded a greater than 1 log increase in viral activity. However, there were no facts to show that EcoHealth notified the NIAID Program Officer and Grants Management Specialist as required by the No Section IV special term and condition.
In a letter dated October 20, 2021, the NIH informed EcoHealth that in order to continue its analysis of the Year 5 I-RPPR, the NIH required verification that WIV received approval from the Institutional Animal Care & Use Committee (IACUC), for field work (e.g., work in caves to collect materials from live bats) supported by R01AI110964, as required by the NIH Grants Policy Statement, 4.1.1.2.
As such, the NIH requested WIV provide documentation verifying IACUC approval. The NIH also requested that EcoHealth provide all unpublished data supported by the grant that had not already reported in its RPPRs. The NIH requested that the materials be provided by no later than October 27, 2021.
On January 25, 2023, the HHS OIG issued Audit Report Number A-05-21-00025, titled, "The National Institutes Of Health And EcoHealth Alliance Did Not Effectively Monitor Awards And Subawards, Resulting In Missed Opportunities To Oversee Research And Other Deficiencies." The report recommended that the NIH consider whether it was appropriate to refer WIV to the HHS Suspension and Debarment Official (SDO) for potential administrative actions, based on information provided in the audit and any other information available to the NIH.
So why did HHS suspend and propose debarment for the WIV?
The NIH's review of the Year 5 I-RPPR determined that an experiment by WIV, shown in Figure 13 of the report, had possibly yielded a greater than 1 log increase in viral activity, in violation of the terms of the grant. NIH has given WIV several opportunities to disprove this finding, but WIV has failed to do so.
Due to WIV's disregard of the NIH's requests that WIV provide the required materials to support its research reported in the grant RPPRs and I-RPPRs, the NIH's conclusion that WIV research likely violated protocols of the NIH regarding biosafety is undisputed.
As such, there is risk that WIV not only previously violated, but is currently violating, and will continue to violate, protocols of the NIH on biosafety, as set forth in the NIH GPS, Section 4.1.24 "Public Health Security," and the terms and conditions of the No for Grant Number R01AI110964 (e.g., requiring that "Research funded under this grant must adhere to the [Centers for Disease Control (CDC)/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)I)."
Therefore, I have determined that the immediate suspension of WIV is necessary to mitigate any potential public health risk.
The information in the record establishes that the NIH requested materials be provided to support WIV's research on at least two documented occasions, November 5, 2021, and January 6, 2022.
To date, the NIH has not received the requested materials from WIV or EcoHealth (as the pass-through entity on behalf of WIV). For the reasons set forth, it appears that WIV's failure to respond to NIH's request, which was necessary to review allegations that WIV has not satisfied biosafety requirements under the grant, reflect that WIV is not compliant with federal regulations and is not presently responsible.