Page:Interim Staff Report on Investigation into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases.pdf/22

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“As stated above, the September 2022 Science article noted in your letter referenced a potential sub-project, which your letter refers to as the ‘clade 1 study,’ that has not been formally proposed. This potential sub-project would include the generation of chimeric viruses by replacing genes in the less virulent Clade IIa virus with those in the more virulent Clade I virus […].
"As detailed above, this type of research would require a formal proposal to be submitted for review, and the proposal would need to undergo the rigorous review process described in this letter before it could be initiated. This review process would speciﬁcally include an assessment of whether the research may be subject to the HHS P3CO Framework.”^[1] [Bold added for emphasis].
Analysis of the accuracy of the HHS response: As noted above, this statement is incorrect.
The clade I study was included in the bidirectional MPXV gene transfer proposal presented to the NIH IBC in June 2015. There was no rigorous review process for such a project because the proposal predated the HHS P3CO framework, which was announced in December 2017. The review of research for GOF concerns during the 2014-2017 pause were only triggered if the experiments included inﬂuenza, SARS, or MERS. According to the October 19, 2022, Science article, a “safety panel” in 2018 determined that the Moss team gene transfer proposal was not subject to P3CO.^[2]

↑ Prior to the HHS P3CO Framework, research proposals were reviewed to determine whether they were subject to the gain-of-function research pause if the experiments might be reasonably anticipated to confer attributes to inﬂuenza, SARS, and MERS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route. U.S Dep’t of Health & Human Serv., U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Inﬂuenza, MERS, and SARS Viruses (Oct. 17, 2014), https://www.phe.gov/s3/dualuse/documents/gain-of-function.pdf. There was also review for dual use research of concern, but mpox was not on the list of 15 federal select agents that would trigger this additional scrutiny. However, per the 2023 PNAS article by the Moss team, apparently some mpox research was subject to DURC review even though mpox clade 1 is not one of the 15 federal select agents on the DURC list. Neither HHS nor NIH have explained the criteria for conducting a DURC review even if the experiment does not involve one of the listed 15 federal seIect agents. In a May 3, 2024, brieﬁng with Majority committee staff, CDC subject matter experts mentioned mpox research projects at CDC were subject to DURC review. However, the Committee is concerned no system at NIH or HHS exists to ensure adequate DURC review.
↑ According to the March 19, 2024, HHS letter to the Committee, “the [Moss] research team stated during a 2018 IBC review that they would not conduct this experiment without further discussions with the IBC.” Neither HHS nor NIH have provided any further context or explanation for why the Moss research team did not conduct the part of the gene transfer experiment moving genes from clade I to clade II. The timing of the Moss research team statement in 2018 leaves the impression that the Moss research team was worried that review of this part of the experiment would raise concerns with the IBC under the new P3CO framework

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[1] Prior to the HHS P3CO Framework, research proposals were reviewed to determine whether they were subject to the gain-of-function research pause if the experiments might be reasonably anticipated to confer attributes to inﬂuenza, SARS, and MERS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route. U.S Dep’t of Health & Human Serv., U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Inﬂuenza, MERS, and SARS Viruses (Oct. 17, 2014), https://www.phe.gov/s3/dualuse/documents/gain-of-function.pdf. There was also review for dual use research of concern, but mpox was not on the list of 15 federal select agents that would trigger this additional scrutiny. However, per the 2023 PNAS article by the Moss team, apparently some mpox research was subject to DURC review even though mpox clade 1 is not one of the 15 federal select agents on the DURC list. Neither HHS nor NIH have explained the criteria for conducting a DURC review even if the experiment does not involve one of the listed 15 federal seIect agents. In a May 3, 2024, brieﬁng with Majority committee staff, CDC subject matter experts mentioned mpox research projects at CDC were subject to DURC review. However, the Committee is concerned no system at NIH or HHS exists to ensure adequate DURC review.

[p22-2] According to the March 19, 2024, HHS letter to the Committee, “the [Moss] research team stated during a 2018 IBC review that they would not conduct this experiment without further discussions with the IBC.” Neither HHS nor NIH have provided any further context or explanation for why the Moss research team did not conduct the part of the gene transfer experiment moving genes from clade I to clade II. The timing of the Moss research team statement in 2018 leaves the impression that the Moss research team was worried that review of this part of the experiment would raise concerns with the IBC under the new P3CO framework

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