Page:Interim Staff Report on Investigation into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases.pdf/49



The Honorable Cathy McMorris Rodgers Chair Committee on Energy and Commerce U.S. House of Representatives Washington, DC 20515

Dear Chair Rodgers,

I write in further response to your March 30, 2023, and October 20, 2023, letters regarding certain research on mpox and the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).

In your March 30, 2023, letter, you requested information pertaining to NIAID intramural project Poxvirus Host Interactions, pathogenesis and immunity, 1ZIAAI000979, including a potential sub-project your letter refers to as the “clade 1 study” to transfer genes from clade 1 mpox into the clade 2 mpox virus currently circulating in humans (now referred to as clade 2b). Since the Department of Health and Human Services’ (HHS or Department), we have collected additional documentation pertaining to the NIH Institutional Biosafety Committee (IBC) review in 2015 and 2018 of experiments involving clade 1 and a clade 2 virus now known as clade 2a, which appeared years before the different clade 2b virus that was first identified in 2022.

The documentation, which is also being provided to the committee in camera on March 20, indicates that, during the 2015 IBC review, research involving bidirectional transfer of genes between clades I and 2 of the mpox virus was considered and approved by the IBC. However, as has been previously shared with the Committee, no such research involving the replacement of genes in either the clade 2a or clade 2b viruses with genes from clade 1 has been performed, nor are there currently any plans to do so. Additionally, as is reflected in the newest set of documents, the research team stated during a 2018 IBC review that they would not conduct this experiment without further discussions with the IBC. Should the research team want to conduct such an experiment in the future, it would first need to be reviewed and approved by the NIH IBC before proceeding. We appreciate the opportunity to provide this additional clarification.

HHS and NIH take the safe and secure conduct of research very seriously and have robust guidance, procedures, and protocols in place to ensure that intramural and extramural scientists, including those proposing research on mpox, maintain the highest possible standards for biosafety and biosecurity, as well as follow all applicable laws, regulations, and policies. If you