A report by the National Science Advisory Board for Biosecurity highlighted wide gaps in the oversight of controversial projects, funded by the National Institutes of Health, that create “enhanced pandemic potential pathogens.”
The National Institutes of Health (NIH) should improve how it regulates lab-generated viruses that could pose a national security risk, according to its biosecurity advisers.
The National Science Advisory Board for Biosecurity (NSABB) highlighted wide gaps in the oversight of controversial projects that create “enhanced pandemic potential pathogens” in preliminary recommendations to the NIH. The report comes ahead of a public meeting to finalize recommendations this week.
Privately funded research that risks causing a pandemic occurs largely in the shadows, the group found. Meanwhile, NIH-funded research with pandemic risks is falling through the cracks of the agency’s vague internal processes.
On paper, NIH-funded projects that could pose a pandemic risk are subject to an extra layer of regulatory review by the enhanced pandemic potential pathogens committee, or P3CO.
In practice, the NIH refers few research projects for closer scrutiny, the NSABB says, echoing the concerns of nonpartisan experts.
In rare instances where projects are referred for review by the P3CO, the deliberation occurs in secret. The composition of the P3CO is unknown to anyone outside of the process except for the NSABB and a few members of Congress.
The biosecurity advisers say that regulation should be expanded beyond “a small fraction of the life sciences research enterprise” and recommend more transparency to build public trust.
The group also recommends tougher rules for determining whether safer approaches like pseudotyping or in silico experiments could answer the same scientific questions, and evaluating whether the project has a potential payoff for public health.
The group also recommended broadening the definition of an “enhanced pandemic potential pathogen” to include any engineered virus with the potential to overwhelm the healthcare system.
Though not stated explicitly in its report, COVID-19 has demonstrated the capacity of a virus with low virulence but high transmissibility to kill millions and upend hundreds of millions of lives.
The group also recommended expanding the oversight of a related field of research: “dual use research of concern” (DURC). DURC refers to research with scientific aims but which could also be used to generate a bioweapon.
NSABB recommended expanding the definition of DURC to include viruses that pose a national security risk if accidentally released, not just research that could be intentionally weaponized.
The group also recommended subjecting foreign labs using U.S. funds and performing high-risk experiments to U.S. regulations. Last August the NIH terminated a subgrant to the Wuhan Institute of Virology, a lab at the COVID-19 pandemic’s epicenter, for failing to meet U.S. regulations.
The draft recommendations have been three years in the making.
The advisory committee first met to consider changes to regulations in January 2020. The group met unmasked, unaware that the novel coronavirus emerging out of Wuhan, China, would significantly raise the temperature of the debate.
In the intervening years, COVID-19 has moved pandemics out of the realm of abstract threats.
The debate about gain-of-function virology once generated little interest outside the infectious diseases community, with virologists concerned about censorship on one side and epidemiologists and microbiologists concerned about lab escape on the other. It has since moved into the mainstream.
Laboratory-made viruses have drawn unprecedented public concern.
But the issue was placed on the back burner as the advisers responded to more urgent public health needs in the pandemic’s chaotic early months. In 2022, the Department of Health and Human Services (HHS) reconvened the NSABB and held public meetings.
Experts have sought to clarify the conflation of gain-of-function research and the creation of more dangerous viruses.
Tweaking flu strains to grow well in eggs in order to generate annual flu vaccines may be considered “gain-of-function” research, for example. But the benefits of creating more dangerous strains of viruses in the lab have not been well articulated.
The NSABB describes the benefits of enhanced pandemic potential research in terms of what may be possible in the future, stating that “the existence of these technological capabilities creates a moral obligation” to explore its possibilities.
But the NSABB also underlines the need to consider the risks.
Government Accountability Office highlights lack of accountability…
Read full story: ‘Vague and Secretive’: Risky NIH Research Not Adequately Regulated, Experts Say