United States (US) health officials should expand oversight of federally funded research that tweaks deadly viruses to include some less risky types of pathogens, an expert panel has concluded. Its draft report, released on Tuesday, also recommends funding agencies share more information about decisions to approve such work.
The recommendations are welcome news for scientists, lawmakers, and others who have worried the SARS-CoV-2 pandemic has revealed gaps in the rules for so called 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, which are funded by the National Institutes of Health (NIH).
The group’s recommendations, from a working group of the National Science Advisory Board for Biosecurity (NSABB), may also bring some relief to virologists who had worried the oversight would extend to common pathogens that rarely cause serious disease, such as cold viruses. But some experts say the proposed definition of risky research still leaves too much to interpretation and could sweep up routine studies important to public health.
Concerns over GOF studies exploded 12 years ago when two researchers reported that they had tweaked H5N1 avian influenza in ways that made the virus spread more easily between ferrets, a model for human transmission. Although the work was meant to help prepare for pandemics, some experts worried such a souped-up virus could escape from the lab or be released deliberately, potentially sparking a pandemic.
The concerns led to a 3-year moratorium on certain GOF studies of avian influenza, Middle East respiratory syndrome, and severe acute respiratory syndrome, as well as a 2017 Department of Health and Human Services (HHS) policy governing future work. The policy, known as the Potential Pandemic Pathogen Care and Oversight (P3CO) Framework, requires that NIH submit for review by an HHS committee studies that are “reasonably anticipated” to generate an “enhanced” version of a human pathogen that is likely to be both highly transmissible and highly virulent.
The P3CO policy came under new scrutiny 3 years ago after the COVID-19 pandemic broke out in China. A lab in Wuhan had NIH funding to create hybrids of existing bat coronaviruses in order to study whether such viruses might evolve to infect people. Some argued this work—or similar studies—could have created SARS-CoV-2 and that NIH had incorrectly exempted the studies from P3CO review. Critics have also suggested other risky studies are escaping P3CO review, 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 pathogen” to agents that are “likely moderately or highly virulent,” but not necessarily fast-spreading, such as the Ebola virus. It would also include any pathogen that is “likely moderately or highly transmissible” and capable of spreading widely 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 lead to pathogens “likely to pose a severe threat” to public health or national security.
The apparent rationale for that language is to exempt routine GOF research on viruses that don’t usually cause serious disease, such as herpes viruses and cold viruses. But it’s unclear whether other standard studies, such as tweaking seasonal flu viruses to find out whether new mutations are helping them spread, could now require P3CO review, says Andrew Pekosz, a flu researcher at Johns Hopkins University. “I still have a lot of concerns,” he says.
The report also says GOF studies conducted for surveillance or vaccine development, which are now exempt from the P3CO policy, should undergo an expedited review. That policy could apply, for example, to work that adds parts of the Omicron strain of SARS-CoV-2 to a different strain to try 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 reviews of P3CO research should be made public, the report says—a step many observers have called for. HHS also should issue clearer P3CO guidelines for NIH-funded institutions and investigators, and tighten oversight of NIH-funded studies overseas. And the P3CO policy should be expanded to apply to privately funded studies, the report says.
Although generally pleased by the recommendations, Relman and biosecurity expert Tom Inglesby of Johns Hopkins say limiting reviews to pathogens that are “likely to pose a severe threat” is problematic because that assessment would be made by NIH, not the P3CO committee. “It doesn’t make sense … for [an NIH official] to make a judgment before the proposal even enters into the [review] process,” Inglesby says.
Biosecurity expert Gigi Kwik Gronvall of Johns Hopkins is concerned that the phrase “reasonably anticipated” will remain part of the P3CO definition. She notes that a government watchdog group this week concluded that without a “standard” to explain that phrase, agencies’ interpretation will be subjective.
The full NSABB will vote on whether to accept the report at a 27 January meeting. If the group approves it, NIH and HHS will then decide whether to revise the P3CO policy,
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Temperatures continued to rise at an alarming pace in 2022, which became the fifth- or sixth-hottest year in modern history, US and European science agencies reported last week. Earth’s average recorded surface temperatures were some 1.2°C warmer than preindustrial times. Nearly 30 countries set individual all-time heat records, and some 850 million people experienced the warmest temperatures of their lives last year. As in 2021, the warming was suppressed by a persistent, multiyear La Niña cooling pattern in the tropical Pacific Ocean, the agencies said. But La Niña is expected to wane this year, setting the stage for even higher temperatures. Meanwhile, the world’s oceans, which capture 90% of the excess heat from global warming and are less prone to short-term temperature fluctuations, again had their hottest year on record in 2022—as they have nearly every year since the 1990s.
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China’s government said last week that nearly 60,000 people have died after contracting COVID-19 since it abandoned its zero-COVID policy on 7 December 2022—a major departure from previous assertions, deemed not credible by outsiders, that fewer than 10 people per day died since the policy ended. The new tally includes hospitalized patients for whom COVID-19 was either the direct cause of death or a contributing factor, a National Health Commission official said at a 14 January press briefing. The average age of the deceased was 80, and more than 90% had underlying conditions. The official added that 300,000 COVID-19 patients have been hospitalized and that infections are now tapering off.
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Alarmed by the country’s sagging industrial prowess and a dearth of jobs for Ph.D holders, the Japanese government will offer tax breaks for corporations hiring recent doctoral graduates. Starting in April, companies will be able to claim a corporate tax credit worth 20% of salaries and other costs associated with hiring researchers who’ve earned a Ph.D within the past 5 years. To qualify, companies also have to boost the share of R&D salaries going to staff with a doctoral degree by at least 3% annually. Ph.D holders face bleak job prospects in Japan. Companies prefer hiring people with master’s degrees and training them in-house, and the number of research positions at Japan’s publicly supported universities is effectively capped.
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It’s official: China’s population has started to shrink, a turning point that could herald major economic challenges. In 2022, the number of Chinese residents—excluding those of Hong Kong, Macau, and Taiwan—fell by 850,000 people to 1.4 billion, China’s National Bureau of Statistics announced this week. The drop, the country’s first since the 1960s, was computed before the current wave of COVID-19 deaths began and may have been accelerated by couples deciding against having children during the pandemic. Demographers had long predicted the decline and expect it to be a long-term trend. China’s birth rate has fallen for years, even after the government ended its one-child policy in 2016, and is now among the world’s lowest. One reason is the large-scale migration to cities, where raising children is expensive, demographers say.
Lalita Panicker is Consulting Editor, Views and Editor, Insight, Hindustan Times, New Delhi
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