For nearly nine years, Anthony Fauci’s institute concealed its plan to create a mpox virus capable of causing a pandemic with a mortality rate of up to 15%, congressional investigators revealed Tuesday in a new report.
In June 2015, a scientist at the National Institute of Allergy and Infectious Diseases received formal approval from the Institutional Review Board of the National Institutes of Health for experiments to create an mpox virus with high transmissibility and moderate mortality .
NIAID — the institute that Fauci oversaw for nearly four decades and which funds most federally funded gain-of-function research — hid approval of the project from investigators at the Energy and Trade Committee. Commerce by the House of Representatives during a 17-month investigation.
A new interim report describes the obstruction and secrecy around the mpox proposal as a case study in how the institute “oversees and reports on monitoring of concerning, potentially dangerous gain-of-function research.”
The revelations come amid global concerns about whether coronavirus gain-of-function research – research that could generate pathogens with increased pathogenicity or transmissibility – could have contributed to the worst pandemic in a century.
The committee, along with the House Oversight and Reform Committee, is also investigating gain-of-function coronavirus research sponsored by the NIAID at the Wuhan Institute of Virology, and faces similar obstacles in that investigation, a committee aide said.
NIAID’s lack of transparency regarding the proposed mpox experiment for nearly a decade undermines Fauci’s assurances at a congressional hearing last week that any biosafety violations at the Wuhan lab could have no connection to his former institute. Investigators continue to seek documents from EcoHealth Alliance, an NIAID contractor whose funding was recently suspended for failing to properly supervise coronavirus experiments exported to Wuhan.
Monkeypox, formerly known as monkeypox, caused a public health emergency in the United States between August 2022 and February 2023. It is endemic in Africa. The most lethal clade circulates in Central Africa (clade I) while the most 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 — although some experts believe it is a undercounting of actual cases. A strain of the clade II virus was the cause of the American epidemic.
The mpox experiment was first revealed in a September 2022 article in Science.
The gain-of-function project proposed by NIAID virologist Bernard Moss would merge genes conferring high pathogenicity from the clade I virus to the more transmissible clade II virus. The new “chimeric” (combined) virus could have retained up to a 15% mortality rate and a reproduction rate of 2.4, a measure of transmissibility indicating that each sick person could infect up to 2.4 people in medium, which gives it pandemic potential.
The committee’s attempts to learn more about the experiment encountered obstacles.
The NIAID maintains that the experiment was never conducted, but has never provided contemporaneous documents to support this claim, such as emails or laboratory notebooks, according to the committee report.
The lack of commitment from NIAID, the National Institutes of Health, and the Department of Health and Human Services does not match the idea that 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 commission launched its investigation in October 2022 but was only allowed to see key documents in camera in March 2024, which confirmed formal approval of the experiment by the NIH.
The committee places blame on NIAID officials, who fund most federally funded gain-of-function research, have the expertise on the subject, 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 spat with the Science journalist in 2022 without serious intention.
However, during the committee’s investigation in May 2023, a Federal Select Agent Program approval for a chimera involving both clade I and clade II of the mpox virus was revoked.
The NIAID also misled Science and STAT News asserting that the gain-of-function mpox experiment was never approved, according to the committee.
Committee aides say they will continue to push 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 head of NIAID in December 2022; Jeanne M. Marrazzo is now director of the institute. Former NIH Director Francis Collins retired in December 2021; Monica Bertagnolli is now director of the NIH.
These revelations also come amid a debate over the future of regulation of gain-of-function research.
The new policy unveiled last month by the White House Office of Science and Technology Policy maintains a largely self-regulatory framework, placing the responsibility for initiating increased regulation on researchers and funding agencies such as NIAID.
The vast majority of gain-of-function research that could generate viruses with epidemic and pandemic capacity will likely be exempt from more rigorous review under the new protocols, according to the committee.
Many of the world’s best-known virologists have dismissed the theory that the COVID-19 pandemic could be the result of a laboratory accident as a conspiracy theory and have chafed at the idea that the work should be regulated by an outside agency, subject to public notice or public opinion. not pursued at all.
This culture also extends to NIAID, according to committee investigators, who also found that top administrators may have illegally circumvented federal records retention and transparency law.
Concerns were raised by a committee aide that NIAID may have exerted undue influence within OSTP to preserve the laissez-faire status quo.
“The new OSTP policy continues to give funding agencies, such as NIAID, primary responsibility for oversight of GOFROC and DURC experiments involving potentially harmful pathogens,” the committee report states. “In almost any other field of science or industry, this arrangement would be immediately recognized as a conflict of interest, requiring independent review and oversight. »
Policy improvements suggested by the committee’s report include codifying public input through a community oversight board, which already exists for high-containment biosafety level four laboratories, as well as moving the final approval of gain-of-function research outside of NIAID.
According to the National Academies of Sciences, Engineering and Medicine, the number of laboratories capable of culturing orthopoxviruses like mpox and smallpox from scratch currently stands at fewer than 100, but could increase significantly as as DNA synthesis and engineering techniques improve and become cheaper.