The National Institutes of Health this week ordered a sweeping review of government policies for experiments involving potentially dangerous viruses and other pathogens, a move the agency said will balance the benefits and risks of such research but is unrelated to the debate over the coronavirus pandemic’s origin.
The review will be conducted by the National Science Advisory Board for Biosecurity, and NIH hopes to have recommendations by the end of the year. In essence, this is a plea for help in deciding where to draw the line on research, identifying the experiments that require special safety measures or are too dangerous to be initiated.
“This is an appropriate time for us to undertake and ensure that our policies are allowing potential benefits of research while managing potential risks,” Lyric Jorgenson, acting associate director for science policy at NIH, said Tuesday. “This is around definitions of what should be in and what should be out.”
Biosecurity and biosafety in scientific research have been intensely controversial topics for years. A decade ago, the debate raged over the publication of research on influenza viruses, which some scientists feared could be used by hostile actors to create a bioweapon.
More recently, the focus has been on whether what happens in labs can stay in labs. The global disaster of the pandemic gave rise to “lab leak” conjectures that have remained speculative.
NIH and other government agencies support research on pathogens conducted under strict safety standards. Jorgenson said the goal with the new review is to make sure the biosecurity policies keep pace with the science.
“These pathogens exist in nature. They mutate and evolve all the time,” Jorgenson said, citing the way influenza mutates every year, and how the coronavirus evolves as it spreads across the planet and generates new variants.
“We need to be studying it and anticipating it so we can counterbalance it if a situation arises,” Jorgenson said. “We have to make sure we are doing it in the right containment level, and the right biosecurity measures are in place.”
On Monday, NIH convened a virtual meeting of the biosecurity advisory board, which will review two categories of experiments.
One is known as “gain of function” research. Such experiments study pathogens with the potential to become more capable of infecting humans or more transmissible among people. NIH calls this “research with enhanced potential pandemic pathogens.”
The advisory panel will also look at dual use research, which could provide useful knowledge but also pose a threat if misapplied. For example, an effort to understand a pathogen could be exploited to create a bioweapon.
NIH in January 2020 asked the biosecurity panel to start a review of policies, but that effort was postponed because of the pandemic, when members of the advisory board were needed at their home institutions, according to the agency.
“Research involving pathogens is vital for ensuring the United States is prepared to rapidly detect, respond to, and recover from future infectious-disease threats. Such research can be inherently high risk given the possibility of biosafety lapses or deliberate misuse,” NIH acting director Lawrence A. Tabak said in a statement announcing the review. “However, not doing this type of research could impair our ability to prepare for and/or respond to future consequential biological threats.”
Several scientists who study viruses and emergent diseases said they welcome the review of biosafety policies.
“I think it’s really important to review this stuff and to regulate it, and make sure that it’s regulated in the right way,” said Angela Rasmussen, a virologist at the University of Saskatchewan.
She acknowledged that the review will be conducted amid a maelstrom of conjectures and conspiracy theories about the coronavirus’s origin.
“Thanks to Twitter and thanks to the ‘lab leak’ [conjecture], we have a lot of newly minted biosecurity experts in the social mediaverse,” she said. “Really, the biggest thing that’s going to be important to communicate to the public is that this is not an investigation of the lab leak theory.”
Kristian Andersen, an immunologist and infectious-disease expert at Scripps Research who was the lead author of a March 2020 Nature Medicine paper saying the coronavirus was not engineered, said an upgrade to safety procedures would be timely given new knowledge about coronaviruses. “That has nothing to do with trying to understand the origin of the pandemic,” he said.
The scientific community has generally rejected the broad spectrum of “lab leak” theories, which range from China intentionally developing a bioweapon — a possibility U.S. intelligence agencies ruled out — to a purely accidental leak of a virus that researchers were unaware was in their laboratory.
Obstructionism and lack of transparency from the Chinese government have impeded independent investigations of the virus origin. Some Republicans in Congress and conservative media commentators have contended, without hard evidence, that the origin of the virus involved a Chinese research facility, with most attention focused on the Wuhan Institute of Virology.
Some research there was partially funded by the National Institute of Allergy and Infectious Diseases, led for nearly four decades by Anthony S. Fauci, President Biden’s chief medical adviser for the pandemic. There is no evidence the novel coronavirus was ever in the Wuhan Institute of Virology before the pandemic.
Scientists who explore the emergence of the novel coronavirus largely favor the hypothesis that it originated through a purely natural “zoonosis,” probably involving animals sold at the Huanan Seafood Market in Wuhan. A significant percentage of the first patients identified with covid-19 had direct links to the sprawling market or lived nearby.
The market hypothesis was further advanced Saturday with the posting online of two scientific papers, not yet peer-reviewed or published in a journal, written by large collaborations of scientists and together arguing that the market was clearly the epicenter of the pandemic.
One paper provided an analysis of the geographical clustering of patients in the vicinity of the market. The authors of that study — Rasmussen and Andersen among them — said environmental samples inside the market showed the virus was disproportionately evident in stalls selling animals. Five positive samples were in a stall that had been seen by one of the paper’s authors in 2014 selling raccoon dogs, a mammal capable of carrying coronaviruses.
The other paper said genetic analysis of early cases revealed the presence of two independent lineages of the virus. That suggested to the authors that the “spillover” from an animal happened not once but twice and possibly even more often — with the additional lineages hitting a dead end without gaining traction in the community.
Although the clustering of cases in and around the market has been known since the start of the pandemic, proponents of the “lab leak” conjectures have said the market could have been merely the location of a superspreader event.
The new research leaves many questions yet to be answered, noted Andersen, a co-author on both papers.
“We pinpointed the market, but that’s basically all we know. We don’t know which animals, we don’t know where they came from,” Andersen said.
Scientists are hoping Chinese researchers release more raw data from the environmental samples described in a paper posted online Friday but not yet peer-reviewed. The paper said it “provided convincing evidence of the prevalence of SARS-CoV-2 in the Huanan Seafood Market during the early stage of COVID-19 outbreak.”
The newly posted scientific papers should end debate about where the pandemic began, said Robert F. Garry, a Tulane University virologist who was a co-author on both papers as well as the 2020 Nature Medicine report.
“It pretty much screws the lid on it as far as I’m concerned,” said Garry, who has been among the most vocal opponents of the lab leak speculation.
Echoing Andersen, Garry said NIH’s biosafety review is necessary given new discoveries of viruses that circulate in great quantity in bats and can jump easily into other animals, potentially triggering another pandemic. One example: BANAL-20-52, a coronavirus discovered in Laos that Garry believes could be an ancestor, or close relative, of the novel coronavirus.
Many researchers believe these viruses should be studied only in high-security facilities, Garry said in an email.
“Virologists are very tired of being painted as reckless cowboys,” he said, adding that regulations covering experiments are already “very comprehensive.”