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

 *“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.” [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.''