For nearly nine years Anthony Fauci’s institute concealed plans to engineer a pandemic capable mpox virus with a case fatality rate of up to 15 percent, congressional investigators revealed in a new report Tuesday.
In June 2015, a scientist at the National Institute of Allergy and Infectious Diseases received formal approval from the National Institutes of Health’s Institutional Review Board for experiments expected to engineer an mpox virus with high transmissibility and moderate mortality.
NIAID — the institute Fauci oversaw for nearly four decades and which underwrites most federally funded gain-of-function research — concealed the project’s approval from investigators with the House Committee on Energy and Commerce over the course of a 17 month-long investigation.
A new interim report describes the obstruction and secrecy around the mpox proposal as a case study in how the institute “oversees and accounts for the monitoring of potentially dangerous gain-of-function research of concern.”
The revelations land amid global concerns about whether coronavirus gain-of-function research — research that might generate pathogens with increased pathogenicity or transmissibility — may have contributed to the worst pandemic in a century.
The committee, in conjunction with the House Committee on Oversight and Reform, is also investigating coronavirus gain-of-function research underwritten by NIAID at the Wuhan Institute of Virology, and faces similar stonewalling in that investigation, a committee aide said.
NIAID’s lack of transparency surrounding the proposed mpox experiment for nearly a decade undermines Fauci’s assurances at a congressional hearing last week that any biosecurity breach at the Wuhan lab could not have any connection to his former institute. Investigators continue to pursue documentation from EcoHealth Alliance, an NIAID contractor whose funding was recently suspended for failing to properly oversee coronavirus experiments exported to Wuhan.
Mpox, formerly known as monkeypox, caused a public health emergency in the U.S. from August 2022 to February 2023. It is endemic in Africa. The more deadly clade circulates in Central Africa (clade I) while the more transmissible clade circulates in West Africa (clade II). Mpox has infected more than 20,000 people and caused more than 1,000 deaths in the Democratic Republic of Congo, where clade I predominates, according to the Centers for Disease Control and Prevention — though some experts believe that is an undercount of true cases. A strain of the clade II virus drove the American outbreak.
The mpox experiment first came to light in a September 2022 article in Science.
The gain-of-function project proposed by NIAID virologist Bernard Moss would splice genes conferring high pathogenicity from the clade I virus into the more transmissible clade II virus. The new “chimeric” (combined) virus could have retained up to a 15 percent fatality rate and a 2.4 reproductive number, a measure of transmissibility indicating every sick person could infect up to 2.4 people on average, giving it pandemic potential.
The committee’s attempts to learn more about the experiment were met with stonewalling.
NIAID maintains the experiment was never conducted, but has never provided any contemporaneous documents to support that claim such as emails or lab notebooks, according to the committee’s report.
The lack of engagement from NIAID, the National Institutes of Health and the Department of Health and Human Services does not comport with the idea the experiment was never conducted and that there is nothing to hide, according to the committee.
HHS and NIH misled congressional investigators for nearly a year and a half, falsely denying that Moss had obtained formal approval for this gain-of-function experiment.
The committee launched its investigation in October 2022 but was only permitted to view key documents in camera in March 2024, which confirmed NIH’s formal approval of the experiment.
The committee lays blame with officials at NIAID, who fund most federally underwritten gain-of-function research, have the subject matter expertise, and may have misled their bosses at HHS and NIH.
For months NIAID and Moss had reported to the committee that the mpox experiment had not moved forward and that Moss had simply been spitballing with the Science reporter in 2022 without serious intention.
However amid the committee’s investigation in May 2023 an approval from the Federal Select Agent Program for a chimera involving both clade I and clade II of the mpox virus was revoked.
NIAID also misled Science and STAT News in saying the gain-of-function mpox experiment was never approved, according to the committee.
Committee aides say they will continue to press for full accountability and transparency, and hope for a culture change at NIAID away from secrecy under new leadership.
Fauci retired after 38 years as the head of NIAID in December 2022; Jeanne M. Marrazzo now serves as director of the institute. Former NIH Director Francis Collins retired in December 2021; Monica Bertagnolli now serves as director of the NIH.
The revelations also come amid a debate about the future of gain-of-function research regulation.
New policy unveiled last month by the White House Office and Science and Technology Policy maintains a largely self-regulatory framework, vesting the responsibility for initiating increased regulation with the researchers and funding agencies such as NIAID.
The vast majority of gain-of-function research that could generate epidemic and pandemic capable viruses is likely to be exempted from more rigorous scrutiny under the new protocols, according to the committee.
Many of the world’s most public virologists have dismissed the theory that the COVID-19 pandemic may have resulted from a lab accident as a conspiracy theory and have chafed at the idea that the work should be regulated by an outside agency, subject to public input or not pursued at all.
That culture extends to NIAID, too, according to the committee’s investigators, who have also uncovered that top administrators may have illegally evaded federal record retention and transparency law.
Concerns were raised by a committee aide that NIAID exerted undue influence at OSTP to preserve the laissez-faire status quo.
“The new OSTP policy continues to give funding agencies, like NIAID, primary responsibility for oversight of GOFROC and DURC experiments involving potentially dangerous pathogens,” the committee’s report reads. “In almost any other scientific field or industry, this arrangement would be immediately recognized as a conflict of interest, necessitating independent review and oversight.”
Policy improvements suggested by the committee’s report include codifying public input through a community oversight board, which already exist for high-containment biosafety level four laboratories, as well as moving final approval for gain-of-function research out of NIAID.
According to the National Academies of Sciences, Engineering and Medicine, the number of labs capable of growing orthopoxviruses like mpox and smallpox from scratch currently stands at less than 100, but could increase significantly as DNA synthesis and engineering techniques improve and become cheaper.
