Federal panel approves plans to safeguard lab-made virus research

A panel of federal advisers voted unanimously Friday to advance a set of proposals to bolster government oversight of pathogen research that could make viruses more transmissible.

The advisers, a collection of biosecurity, ethics and infectious disease experts, united to vote the set of proposals through with minor changes. But some of the scientists who attended the public meeting balked at language that they said could accidentally hinder relatively low-risk gain-of-function research, which manipulates pathogens in order to study a virus’s origins with the aim of developing speedy treatments.

The panel’s draft report, which recommends safeguards including “federal department-level review” of gain-of-function studies and implementing a broader definition of pathogens that could potentially cause pandemics, will be finalized, then sent to top National Institutes of Health officials, which currently do not include a permanent NIH director or a replacement for National Institutes of Allergy and Infectious Diseases Director Anthony Fauci.

Acting NIH Director Lawrence Tabak, a longtime deputy of former NIH Director Francis Collins, spoke at the start of the meeting and stayed throughout, but didn’t chime in as public commenters and panelists themselves questioned how the policies would be implemented and how some virus-related research could be unintentionally hampered.

The proposals, if implemented, would only apply to U.S.-funded research. But as attendees spoke, they noted the policies would likely ripple through academic arenas and global research efforts.

For some, the prospect of broadening the definition of pandemic-potential viruses was troublesome, especially if it meant roadblocks for research into their possible spread.

“Experimental transmission studies do not always mimic human conditions, and are not always predictive of transmissibility in humans,” said Seema Lakdawala, an epidemiologist at Emory University. “They are the best that we have at the moment,” but calculating risk for humans off of studies in lab animals is still “highly inaccurate,” she added.

Lakdawala pushed for federal regulators to partner with researchers who “understand the nuances behind the systems we use to study things like transmission.”

Some board members also voiced concerns, especially about how the new measures could impact researchers’ ability to speedily develop vaccines and treatments based on a virus’s evolution.

Vanderbilt University professor and NIH adviser Mark Denison pointed out that Covid-19 monoclonal antibody therapies require near-constant pivots as treatments are rendered useless against evolving strains.

“Would we say that we’re going to have these companies make [therapies], people are going to work on them, they’re going to save human lives, but we can’t allow any prospective study to try to understand how the virus might escape from those because we might create a risk that that virus would then be in the community?” Denison said.

Other experts heralded the proposal as an important step in strengthening biosecurity and quelling public concerns about infectious disease research fueled by frustration around the coronavirus pandemic and political rhetoric.

The NIH panel met nearly two weeks after a government watchdog group separately made similar recommendations to bolster oversight and transparency around infectious disease studies.

NIH advisers largely defended the recommendations, arguing they simply inscribe what have long been best practices in study design, especially when it comes to safeguards meant to prevent viruses from spilling out of the lab.

“The idea was not to ban any kind of research, but to — if there are concerns identified — find ways to mitigate them,” said Dennis Metzger, professor emeritus in immunology and microbial disease at Albany Medical College.

Still, nearly everyone acknowledged the charged atmosphere around pandemic-potential viruses.

Rachel Levinson, executive director of research initiatives at Arizona State University, said that while the panel is not involved in implementing the potential policies, regulators will need to follow through on concerns that policy shifts could slow research.

“This is going to represent a fairly large change and one that has a lot of public attention being paid to it,” she said. “Maybe it’s institution by institution, but we need to make sure that it is not inadvertently inhibiting important research.”

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