US should extend rules on risky virus research to include more pathogens, panel says  Science

US should extend rules on risky virus research to include more pathogens, panel says Science

US should extend rules on risky virus research to include more pathogens, panel says  Science

U.S. health officials should expand oversight of federally funded research that tweaks deadly viruses to include some less risky types of pathogens, according to a panel of experts. The draft report released today also recommends that funding agencies share more information about decisions approving such work.

The recommendations are welcome news for scientists, lawmakers and others concerned that the SARS-CoV-2 pandemic has revealed gaps in the rules governing gain-of-function (GOF) research. The report recommends “significant improvements in policy,” says Stanford University microbiologist David Relman, a critic of US oversight of GOF studies funded by the National Institutes of Health (NIH).

The group’s recommendations, from a National Science Advisory Board for Biosecurity (NSABB) working group, may also bring some relief to virologists, who had feared oversight would extend to common pathogens that rarely cause serious illness, such as the virus. B. Cold viruses. However, some experts say the proposed definition of risky research still leaves too much room for interpretation and could sidestep routine studies important to public health.

Concern about GOF studies exploded 12 years ago when two researchers reported that they had engineered the H5N1 avian flu so that the virus spread more easily between ferrets, a model for human transmission. Although the work was intended to prepare for pandemics, some experts feared that such a souped-up virus could escape the lab or be released intentionally, potentially sparking a pandemic.

The concerns led to a three-year moratorium on certain GOF studies on avian influenza, Middle East respiratory syndrome, and severe acute respiratory syndrome, as well as a 2017 Department of Health (HHS) guidance on future work. The policy, known as the Potential Pandemic Pathogen Care and Oversight (P3CO) Framework, requires the NIH to submit studies for review by an HHS committee that are “reasonably expected” to have an “expanded” version of a probable human pathogen both highly transmissible and highly virulent.

The P3CO policy came under scrutiny again 3 years ago after the outbreak of the COVID-19 pandemic in China. A lab in Wuhan had received NIH funding to create hybrids of existing bat coronaviruses to study whether such viruses could evolve to infect humans. Some have argued that this work — or similar studies — may have generated SARS-CoV-2 and that the NIH incorrectly exempted the studies from P3CO review. Critics have also suggested other risky studies escape P3CO scrutiny, such as a proposal to combine two strains of the mpox virus.

Today’s NSABB report calls for expanding the definition of a “potential pandemic agent” to include agents that are “likely to be moderately or highly virulent” but not necessarily fast-spreading, like the Ebola virus. It would also include any pathogen that is “likely to be moderately or highly transmissible” and capable of widespread transmission in humans, such as SARS-CoV-2. Similar changes were included in a draft released in September 2022. But the new version also adds a condition that limits reviews to work that could result in pathogens “likely to pose a serious threat” to public health or national security.

The obvious reason for this language is to exempt routine GOF research on viruses that don’t normally cause serious illnesses, such as herpesviruses and cold viruses. However, it is unclear whether other standard studies, such as For example, tweaking seasonal flu viruses to see if new mutations help them spread might now require P3CO screening, says Andrew Pekosz, a flu researcher at Johns Hopkins University. “I still have a lot of worries,” he says.

The report also says that GOF studies conducted for surveillance or vaccine development, which are now exempt from the P3CO policy, should be subject to expedited review. For example, this policy could apply to work adding parts of the Omicron strain of SARS-CoV-2 to another strain to understand why Omicron causes milder symptoms. Such a study at Boston University caused an uproar last fall.

A summary of the HHS committee’s assessments of P3CO research should be released, the report said — a move many observers have called for. HHS should also issue clearer P3CO guidelines for NIH-funded institutions and investigators, and tighten oversight of NIH-funded studies abroad. And the P3CO policy should be extended to privately funded studies, the report says.

While Relman and Johns Hopkins biosafety expert Tom Inglesby are generally pleased with the recommendations, they say that limiting screening to pathogens “likely to pose a serious threat” is problematic because that review is done by the NIH and not the P3CO committee would be made. “It doesn’t make sense… for [an NIH official] to make a judgment before the proposal even enters the [review] process,” says Inglesby.

Johns Hopkins biosecurity expert Gigi Kwik Gronvall fears that the phrase “reasonably expected” will remain part of the P3CO definition. She notes that a government monitoring group concluded this week that without a “standard” to explain that phrase, the authorities’ interpretation will be subjective.

The full NSABB will vote on whether to accept the report at a meeting on January 27th. If the group agrees, the NIH and HHS will decide whether to revise the P3CO policy.

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