Chikungunya, which means “bent over in pain” in the Makonde language, can lead to chronic arthritis, and its spread through the Americas had made studying it more urgent. The researcher’s team at Washington University School of Medicine in St. Louis, Missouri, was studying the virus in the hope of discovering possible treatments or developing a vaccine. The graduate student was working in a biosafety level 3 lab, a level that often includes a completely sealed perimeter, directional airflow, and full personal protective equipment. But accidents still happened. The team’s experiments were set back when, after withdrawing the needle from the mouse’s belly, the graduate student grazed a finger on her left hand.

The needle pierced through both sets of gloves, but the student saw no blood, so she washed her hands, removed her safety equipment, and left the lab without telling anyone what had happened. Four days later, she ran a fever, and her body ached and convulsed in chills. The next morning, her skin was flecked with discolored spots. They multiplied over the course of the day, so she went to the emergency room, where the doctors kept her overnight for observation. A nurse drew her blood and sent it off to a state lab. She tested positive for Chikungunya. Only after getting sick did the student tell her supervisor about the slipped needle.

“That’s not a good situation,” said Scott Weaver, director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch at Galveston and an expert on Chikungunya virus. “If that person knew they had a needlestick and they were working with Chikungunya, they should have reported it immediately. And then whatever health care people saw them should have recognized that there was a very small — but not zero — risk of them transmitting the virus.”

After the student told her supervisor about the accident in September 2016, Washington University reported it to the National Institutes of Health, but until now, the event has remained out of public view. So have hundreds of other incidents in U.S. labs, including four other needle injuries at Washington University.

An Intercept investigation based on over 5,500 pages of NIH documents obtained under the Freedom of Information Act has uncovered a litany of mishaps: malfunctioning equipment, spilled beakers, transgenic rodents running down the hall, a sedated macaque coming back to life and biting a researcher hard enough to lacerate their hand. Many of the incidents involved less dangerous pathogens that can be handled with basic safety equipment, and most did not lead to infection. But several accidents happened while scientists were handling deadly or debilitating viruses in highly secure labs, and a few, like the Chikungunya virus slip-up, did lead to illness.

“People have it in their minds that lab accidents are very, very rare, and if they happen, they happen only in the least well-run overseas labs,” said Richard Ebright, a molecular biologist at Rutgers University and an advocate for better biosafety standards. “That simply isn’t true.”

The United States has a patchwork of regulations and guidelines covering lab biosafety. Safety training can vary widely from one institution to the next. Experiments involving certain pathogens and some research funded by the U.S. government is subject to oversight, but critics say that other areas are like the Wild West. Unless they work with the most dangerous pathogens, biolabs don’t have to register with the U.S. government. As a result, there is little visibility into the biosafety of experiments carried out by private companies or foundations.

“Your favorite tech billionaire could, with their own money, do basically whatever the hell they want with any pathogen,” said Rocco Casagrande, managing director of Gryphon Scientific, a biosafety advisory firm that has advised NIH on biosafety standards. “They could take the measles virus and intentionally try to make it vaccine-resistant and more pathogenic in their garage. If they’re doing it for legitimate research purposes in their own minds, they can do so wildly, unsafely, and no one can stop them.”

As policymakers scramble to prevent future pandemics, those gaps have been thrust into the spotlight. A Senate subcommittee held a hearing in August on the oversight of dangerous pathogens, and NIH, the world’s largest funder of biomedical research, has convened an advisory panel to consider how the agency vets proposals for risky science. In September, the World Health Organization published guidance aimed at “preventing the accidental and deliberate misuse of biology and other life sciences” around the world. That same month, the White House issued an executive order tasking the secretaries of Health and Human Services and Homeland Security with devising a plan to improve biosafety research, noting a need to prevent biotechnology from leading to “accidental or deliberate harm to people, animals, or the environment.” (The Department of Health and Human Services oversees NIH.) In October, the White House unveiled a broader biodefense plan that includes a pledge to strengthen lab biosafety and biosecurity.

Since the question of how to prevent future pandemics is related to the still unsettled question of how the current pandemic started, the policy discussions have been shot through with politics. In Congress, the issue of biosafety regulation has been pushed almost exclusively by Republicans, the very same party that helped usher in the expansion of the U.S. biolab network after September 11. (Many Democrats also supported the effort at the time.) The NIH advisory panel’s members are installed by agency leadership, making them unlikely to buck the status quo. Broader discussions about biosafety, meanwhile, have devolved into bitter Twitter fights.

Biosafety proponents maintain that regardless of what caused the SARS-CoV-2 outbreak in China in 2019, the fact that a lab accident could spark a pandemic is reason alone for better oversight. Many virologists, meanwhile, contend that more regulation is unnecessary and that the benefits of their research outweigh the risks. “There’s a whole community of scientists who downplay the fact that things can be acquired in the lab,” said Stuart Newman, a cell biologist at New York Medical College who sits on his university’s institutional biosafety committee.

The documents show that the threat is real.

The Intercept obtained 18 years of lab incident reports submitted to NIH, which oversees research as well as funds it. Some of these were obtained directly, through a Freedom of Information Act request. Others were obtained by Edward Hammond, former director of the Sunshine Project, and Lynn Klotz, senior science fellow at the Center for Arms Control and Non-Proliferation, who separately requested the reports using FOIA and then provided them to The Intercept. The reports span the period of 2004 to 2021. Institutions funded by NIH are required to report any mishaps involving recombinant DNA to the agency’s Office of Science Policy.

Among the accidents revealed in the documents:

• In 2010, a machine in a University of California, Irvine lab malfunctioned while decontaminating waste from experiments with the SARS virus. The machine, called an autoclave, leaked steam and water, potentially exposing eight people to the virus, which could spark a pandemic. The risk of an outbreak was mitigated by a quirk of timing: The machine had already reached a high temperature — likely enough to kill the virus — before malfunctioning. The University of California, Irvine spokesperson Tom Vasich wrote in an email, “The incident was quickly addressed. … Released materials were contained in our BSL3 laboratory. Exposed lab workers were wearing proper personal protective gear. No transmission of the virus was detected.”
• In 2013, a researcher at Kansas State University in Manhattan, Kansas, pricked their finger while drawing blood from a chicken infected with H5N1 avian influenza. The scientist had handed a used syringe to an assistant while trying to get a better grasp of the chicken’s jugular vein. The assistant returned it needle side out, piercing through the scientist’s gloves. The researcher was prescribed Tamiflu for one week and told to immediately report a fever. Kansas State University did not respond to a request to comment.
• Between April 2013 and March 2014, the University of North Carolina at Chapel Hill reported five mouse escapes, including one of an animal that had been infected with SARS four days earlier. In a letter to NIH, a biosafety specialist argued that the frequency of escapes was due to the “complex research taking place at our institute” rather than a failure of training, noting that several teams at the university use a breed of transgenic mouse known for its unpredictable behavior. After the SARS-infected mouse darted under lab equipment, researchers cornered it with a broom and returned it to its cage. The University of North Carolina did not respond to a request to comment.
• In 2018, a researcher at the Food and Drug Administration’s Center for Biologics Evaluation and Research in Silver Spring, Maryland, contracted a MRSA infection, a condition that can become severe if left untreated, after working with the antibiotic-resistant bacteria MRSA in the lab. The researcher could not recall any mishaps that would have led to infection, a situation that experts say is common with laboratory-acquired infections. The FDA center did not respond to a request to comment.
• In early 2020, amid the shortage in respirators and masks brought on by the pandemic, a lab at Tufts University conducted low-risk experiments with the H3N2 flu virus without proper equipment. A student spilled a test tube containing a small about of virus, potentially exposing five people. None were initially wearing masks. (Two later put them on to clean up the spill.) H3N2 is a seasonal flu virus and not considered a dangerous pathogen, but in an email to Tufts, an administrator at NIH highlighted a series of omission and errors. These included the lab’s failure to provide personal protective equipment, a lack of proper safety signage, and the failure of researchers to seek appropriate medical care after being exposed to the virus. The NIH administrator also recommended that the principal investigator be retrained. Tufts declined to comment.

In an analysis of incident reports filed with the Office of Science Policy between 2004 to 2017, Klotz found seven lab infections that initially went undetected or unreported, in addition to the Chikungunya case. Critics say that even a few laboratory-related infections is too many, because often they are avoidable. Lab accidents are typically the result of “cascading errors,” said Casagrande. “Some physical mistake happens that then takes advantage of vulnerabilities introduced by someone’s carelessness or mental mistake or happenstance. Someone spilled something when the backup fan happens to be knocked out by a power outage, or someone spilled something on the day that their lab coat was at the cleaner.”

Cascading Errors

The Washington University case shows how errors can multiply. If the graduate student had promptly reported the needle prick instead of waiting until after she got sick, she could have stayed inside, preventing mosquitoes from feasting on her blood and potentially sparking an outbreak of Chikungunya. According to Weaver, people infected with Chikungunya have the most virus in their blood one to four days after transmission, the very period during which the student went about her life without knowing that she was infected. And while Americans’ habits of spending long hours indoors drastically reduced the chance of local transmission — “Because of our culture, we just don’t get very many mosquito bites,” Weaver said — it’s likely that a vector for transmission was present. In 2016, a survey of Missouri’s mosquito population found that a species that the World Health Organization says is implicated in the spread of Chikungunya, Aedes albopictus, was “very abundant” in southern Missouri.

In the 2016 report to NIH’s Office of Science Policy, Washington University biological safety officer Susan Cook did not name the principal investigator who oversaw the graduate student. The report also omits the name of the infected graduate student, as is standard practice for such documents. (Biosafety experts stress that while accidents can reflect problems with a lab’s culture or training, they should not be seen as an indictment of one researcher’s behavior.)

The Intercept sent a detailed list of questions to Cook along with Deborah Lenschow and Michael S. Diamond, who separately oversee labs that work on Chikungunya virus at Washington University. All three referred questions to a spokesperson, who sent a statement that she said was authored by Cook.

“As a major research institution, the safety of graduate students and scientists working in BSL3 labs is of paramount importance to us,” the statement reads. “We continually evaluate our laboratory safety policies, procedures and training materials and look for ways to incorporate new technologies and tools so that our labs remain safe and our students and researchers can continue their critical infectious diseases research.” The graduate student recovered within a few days and did not suffer prolonged symptoms, the statement says.

In her 2016 report to NIH, Cook wrote that after the infection, the lab’s principal investigator called a meeting about safety standards, and the university added training materials about needle injuries. She added that at its October 2016 meeting, the university’s institutional biological and chemical safety committee would discuss how to minimize injuries from needle pricks. Minutes from that meeting do not show that the infection was discussed there. Cook wrote The Intercept that “most discussions of specific injury/illness reports are too granular to be captured in the IBC minutes.”

An administrator with NIH’s Office of Science Policy responded by admonishing the institution. “We are concerned that an exposure incident occurred in a BL3 laboratory and went unreported for four days,” he wrote in a letter. He asked Washington University staff to conduct a thorough investigation, explore using different needles, better train researchers, and emphasize that exposures in high-containment labs needed to be reported immediately, not days after they happen. But after that, the correspondence chain ended.

Ryan Bayha, a spokesperson for NIH’s Office of Science Policy, would not comment directly on whether the agency continued the discussion, writing, “Washington University and OSP worked together to successfully resolve the issue involved in the Washington University report.”

“There doesn’t seem to be a lot of enforcement or follow-up actions, and there doesn’t seem to be any real accumulation of learning,” said Greg Koblentz, director of the Biodefense Graduate Program at George Mason University’s Schar School of Policy and Government, after reading the Washington University report and NIH’s response. “It helps demonstrate why we need to have a dedicated organization for biosafety and biosecurity in the United States.”

“No Standard”

The United States has the most robust biomedical funding in the world, and controversial breakthroughs in science often come from American labs. Yet the United States lacks a central framework for lab oversight. Canada’s Centre for Biosecurity oversees all pathogen research, setting standards and training regimens for labs and enforcing them as well. The United Kingdom has centralized reporting for infections acquired in the lab. When it comes to U.S. regulations, “There are some significant holes,” said Filippa Lentzos, an expert on biosecurity and biological threats at King’s College London. Biosafety protocols are “not embedded in statutory law. It’s tied to funding.”

Policies governing the use of so-called select agents and dual-use research are limited to specific toxins and types of experiments, leaving out much work on synthetic DNA. Another crucial set of federal guidelines covers research funded by NIH, the world’s largest biomedical funder. But a host of other entities work with or fund research with pathogens, with varying degrees of oversight: the Defense Advanced Research Projects Agency, the United States Agency for International Development, the Bill and Melinda Gates Foundation, and private companies. “There’s nothing out there that says, if you want to fund research, here’s what you should think about,” said Casagrande. “That doesn’t exist, period.”

There’s reason to worry. The 1977 outbreak of H1N1 influenza in the Soviet Union and China is believed to have been accidentally introduced by scientists, either through a lab accident or through a live-vaccine trial gone awry. In 2003 and 2004, the first SARS virus is suspected to have escaped four times from labs in China, Taiwan, and Singapore. In 2007, wastewater containing live virus leaked out of pipes near a highly secure biolab in Surrey, the United Kingdom, sickening animals in the area with foot-and-mouth disease. Accidents regularly happen at even the world’s top labs. In 2019, the Centers for Disease Control and Prevention ordered the U.S. Army Medical Research Institute of Infectious Diseases to temporarily halt work at a lab in Fort Detrick, Maryland, after identifying biosafety issues there. In addition to the MRSA infection at the FDA lab, the documents obtained by The Intercept include records of accidents at labs operated by the CDC and NIH. (In those two cases, researchers were exposed but not infected.)

Biosafety proponents worry most about accidents with what are called “potential pandemic pathogens”: bacteria, viruses, and other microorganisms that, either through handling or through modification, could set off another pandemic. Some are also concerned about accidents with pathogens like Chikungunya virus, seeing them as sentinel events that reveal broader problems. Because those incidents are more common, they can give insight into the daily workings of biolabs. And some pathogens that don’t pose a significant threat in the United States might ravage populations in other parts of the world, if a researcher were to travel after getting infected.

NIH-funded institutions that conduct research on recombinant DNA have to get experiments approved by an institutional biosafety committee, or IBC. If that work is extensive or done in a BSL-3 or BSL-4 lab, they are also required to appoint a biosafety officer to oversee lab work. But there is broad variation in how both rules are applied.

“There’s no standard for how many biosafety officers you need and indeed, for many types of institutions, whether you need a full-time monitor at all,” said Casagrande. “Sometimes there’s a part-time person, like you’re the biosafety officer and the animal use officer and the prime minister of bagels.”

At Washington University, the accident went unreported for four days. In other cases, accidents went unreported for months or even years, either because the affected researchers stayed quiet or because staff overlooked the incidents. In 2015, a University of Minnesota vice president for research wrote NIH’s Office of Science Policy to say that an employee had failed to report to the agency four incidents, one of which dated back to 2013. (None of the incidents apparently resulted in infection, though in a response letter, NIH noted that in two cases employees failed to get prompt medical attention.) The university discovered the accidents only after a journalist reached out to the institutional biosafety committee to ask for information. “After having questioned why these reports were not made, I have received a note of apology from the person whose responsibility it was to insure [sic] that this reporting was done,” a human resources administrator wrote NIH in an email sent the same day as the vice president’s letter. “She is no longer in the role.” A University of Minnesota spokesperson wrote that they could not comment on the affair because of “laws designed to protect employee privacy” but that since 2015, the university has improved biosafety procedures, training, and reporting and added resources for the institutional biosafety committee.

In another case, an institutional biosafety committee chair reported to NIH a biosafety infraction that had occurred six years earlier.

In the documents obtained by The Intercept, biosafety officers sometimes appear overly credulous. In 2019, an undergraduate student at the University of Illinois Urbana-Champaign who worked with salmonella contracted salmonellosis. She told a staffer that she thought her illness was caused by eating undercooked turkey, not by exposure to the bacteria in the lab. A biosafety officer appeared to accept this as a possible explanation, noting it in an initial email to NIH. (In a later formal report, the officer made clear that the student likely had a laboratory-acquired infection.) The student’s supervisor only learned that the student was sick after she visited the campus health center.

Even basic concepts, like how to train researchers in biosafety, vary widely from one lab to the next. At some labs, researchers are expected to do dry runs of experiments when learning safety techniques. At other places, said Casagrande, training consists mainly of slideshows.

Slides did a lot of work at Washington University too. In her report to NIH on the Chikungunya infection, Cook, the biosafety officer, noted that staff would add slides about working with needles and other sharp objects to an annual lab training presentation.

A Missed Opportunity

Needlesticks, as scientists call needle injuries, were for decades seen as rare. When they did happen, they were believed to rarely lead to infection. Only recently have biosafety experts begun to challenge those assumptions. “Everyone who works with needles needs an emergency plan for when they stick themselves,” said Casagrande. “Anecdotally, people think of it as a once-in-a-career injury, but the data suggests it should be expected on any R01 grant,” he added, referring to a type of five-year research grant provided by NIH.

In the wake of the Chikungunya infection, Washington University doubled down on education about the safe use of needles in the lab. But in a span of 14 months, it happened twice more: In April 2017 and November 2017, researchers at Washington University pricked themselves while working with mice infected with Chikungunya.

In the statement sent by the spokesperson, Cook cited the incidents as a success because the lab workers immediately reported them and did not contract the virus.

Staff at the Office of Science Policy disagreed. After the April incident, an administrator noted that the needlestick had happened in the same lab that had the Chikungunya infection. But the response was otherwise muted. They again recommended more training, this time adding the world “strongly.”

“At the same facility within the span of a year, you had two incidents, and they’re like, ‘Well, do better,’” said Koblentz, referring to NIH.

In a perfect world, he said, the graduate student’s illness would have been used to teach other labs. “Ideally, these kind of incident reporting systems are a preventive measure. If you could learn from the accidents and then tell people, ‘OK, here’s how to avoid them,’ that’s great.”

Because accidents only come to light through attention from the press or civil society groups, there is little data on how frequently specific breaches occur. “There’s no central repository of accidents,” said Lentzos. “The reporting is very opaque.”

Bayha wrote in an email to The Intercept that NIH often develops “guidance documents” following notable lab incidents but conceded that did not happen in the Washington University case. “There was no feedback to the broader community,” said Koblentz. “It’s a missed opportunity.”

The post Student Infected With Debilitating Virus in Undisclosed Biolab Accident appeared first on The Intercept.

The flu is typically transmitted through respiratory droplets, and an animal bite is unlikely to infect a scientist. But with a virus as devastating as 1918 flu, scientists are not supposed to take any chances. The researcher squeezed blood out of the wound, washed it with an ethanol solution, showered, and left the lab. A doctor gave him a flu shot and prescribed him Tamiflu. Then, after checking that he lived alone, a Mount Sinai administrator sent him home to quarantine for a week, unsupervised, in the most densely populated city in the United States. As documents obtained by The Intercept show, staff told him to take his temperature two times a day and to wear an N95 respirator if he got sick and needed to leave for medical care.

NIH guidelines say that only people exposed through their respiratory tract or mucous membranes need to be isolated in a dedicated facility, rather than at home. But some experts contend that the protocols governing research with the most dangerous pathogens should be stronger.  “That is a pretty significant biosafety breach,” said Gregory Koblentz, director of the Biodefense Graduate Program at George Mason University’s Schar School of Policy and Government. Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris, agreed: “Say the risk was 0.1 percent. But if he just happened to be unlucky, then the consequences would be absolutely gigantic.” A researcher stuck in a small apartment in New York City might be tempted to venture outside to get food or fresh air, he added.

Jesse Bloom, an evolutionary virologist at Fred Hutchinson Cancer Center, said that Mount Sinai’s response seemed appropriate. But, he said, the episode shows that “accidents sometimes happen even where there isn’t negligence.” In his view, the solution was simpler: 1918 influenza is so dangerous that experiments with it shouldn’t be done at all.

Adolfo García-Sastre, the lab’s principal investigator, knew firsthand how work with the 1918 flu virus could spark controversy. In 2005, he was part of a team that reconstructed the virus in order to study how it had become so devastating. The effort was the culmination of an outlandish journey, which started when a Swedish microbiologist trekked to Alaska to take a sample of the virus from the corpse of a 1918 flu victim; she had been buried in a mass grave after the virus wiped out most of her village, and her body was preserved in the permafrost. Using that and other samples, scientists spent years sequencing parts of the virus, eventually sequencing the whole genome. García-Sastre and collaborators then used a technique called reverse genetics to make a copy of the virus’s DNA, laying the groundwork for recreating the virus. (The actual reconstruction of the virus was done at a Centers for Disease Control and Prevention lab in Atlanta.) When the team studied the virus in mice, they found that it was incredibly lethal. Some mice died within three days of infection.

Furor ensued. Biosafety proponents argued that the risk of accidental release was not worth taking. No one really knew how potent the virus would be in modern times. Did we want to find out?

The ferret bite happened six years later but has not been publicized until now. For some, it is a stark example of the risks that accompany research on dangerous pathogens.

The mishap and hundreds of others are recorded in more than 5,500 pages of National Institutes of Health documents obtained under the Freedom of Information Act, detailing accidents between 2004 and 2021. The Intercept requested some of the reports directly, while Edward Hammond, former director of the transparency group the Sunshine Project, and Lynn Klotz, senior science fellow at the Center for Arms Control and Non-Proliferation, separately requested and provided others.

The documents show that accidents happen with risky research even at highly secure labs. NIH recently convened an advisory panel to consider how it regulates such experiments.

In 2017, following a protracted controversy over experiments in which scientists tweaked the H5N1 avian influenza virus to make it more transmissible in ferrets, the Department of Health and Human Services adopted new oversight of research on pathogens with the capacity to spark a pandemic. Those guidelines require experiments that are “reasonably anticipated” to confer dangerous new traits to so-called “potential pandemic pathogens” — or create new ones — to undergo a special review process in order to get NIH funding. But as The Intercept has reported, the policy has been unevenly applied.

Some experts are calling for other biosafety policies, such as those outlining what to do after a lab accident, to be tightened as well.  “A lot of our talk now is about potential pandemic pathogens and risks around that,” said Koblentz of the ferret bite. “But the 1918 flu was a known pandemic pathogen. That should have the highest possible level of biosafety and measures taken in the event of an accident or a suspected or known exposure.”

“The downside with that type of pandemic pathogen is so high that it just doesn’t seem to me that there’s any level at which it’s worth it.”

Mount Sinai and García-Sastre did not respond to requests to comment. Mount Sinai reported the ferret bite to NIH, as well as to the CDC and the U.S. Department of Agriculture, as required under a program governing the use of certain toxins called select agents.

“[I]solation in a predetermined facility was not necessary because an animal bite did not meet the definition of known laboratory exposure with a high risk of infection,” wrote Ryan Bayha, a spokesperson for NIH’s Office of Science Policy, in an email. (Bayha was previously an analyst with the office, and the report on the ferret bite was addressed to him.)

Bloom said that experiments with 1918 influenza are scientifically interesting. At one point, he supported doing them. But he came to change his views after considering the risks more holistically. “I now feel that experiments with actual 1918 influenza just shouldn’t be done,” he said. To him, the ferret bite shows that accidents with dangerous viruses happen at even the best, most secure labs. “It’s like a nuclear weapons accident. The downside with that type of pandemic pathogen is so high that it just doesn’t seem to me that there’s any level at which it’s worth it.”

“A Complete Farce”

Many of the biotechnology safety standards in place today trace to 1975, when a group of scientists gathered at the Asilomar Conference Center on the California coast. Advances in biology had recently made it possible to modify DNA by inserting genes from one organism into the genetic code of another, and scientists convened the International Congress on Recombinant DNA Molecules to consider the implications of such research. Though driven by concerns about ethics, the conference would come to be seen by historians and bioethicists as an elite gathering aimed in part at warding off intervention by U.S. Congress.

Three years earlier, Stanford University biochemists Paul Berg and Janet Mertz had sparked outcry when they combined genes from the gut bacteria E. coli with DNA from a type of simian virus that can cause tumors in rodents. They had planned to insert the new DNA back into E. coli, but some of their peers worried that the modified bacteria could cause cancer in lab workers. Others feared that genetically engineered organisms could be used as bioweapons. The Asilomar meeting was organized in part by scientists whose primary interest was in allowing the research to go forward. Berg, under fire, co-chaired the conference.

“They focused on this idea that research is done outside of society — that if scientists can get their act in order and govern themselves, then they don’t have to worry about the broader world,” said Sam Weiss Evans, a senior research fellow at Harvard Kennedy School’s Program on Science, Technology, and Society. “But for many citizens at the time, the issue was very different: Are these scientists going to run rampant and just do whatever they want, or is there going to be some kind of ability for us to have a check on them?”

The critics’ worst fears about carcinogenic gut bacteria did not pan out, but the notion that scientists could set their own guardrails would have long-lasting consequences. The recommendations drawn up by the delegates to the Asilomar conference became the basis for the NIH guidelines on recombinant DNA that, with some revisions, are still in place today.

In 2001, after letters laced with anthrax killed five Americans, the United States adopted new biosecurity regulations, including rules governing the use of select agents. A decade later, the H5N1 controversy spurred another layer of oversight. But in other areas, regulation is lacking, despite breakthroughs in fields like synthetic DNA.

At NIH, meanwhile, critics point to an inherent conflict of interest: The agency is charged with overseeing the same research it funds.

Institutional biosafety committees — or IBCs, review boards at universities and other institutions that evaluate potentially risky research plans for NIH compliance — are another legacy of Asilomar. Scientists devising a new experiment consider the risks and come up with ways to mitigate them: safety equipment, checks, and controls. They then propose that plan to the IBC. But there are no standards in place for an IBC to determine whether the benefits of an experiment actually justify the remaining risks — a glaring problem when it comes to pathogens like the 1918 flu virus.

“Yes, they’re all experts, and yes, they’re all trained in this type of thing, but do we really just want it to be down to a judgment call?” said Rocco Casagrande, managing director of the biosafety advisory firm Gryphon Scientific. “How do you determine if the experiment should be done, if there really aren’t any standards?”

“How do you determine if the experiment should be done, if there really aren’t any standards?”

Critics say that the IBC system, like NIH oversight, also has a conflict-of-interest problem: Research is evaluated by an institution that relies on grant funding. Some institutions even hire out IBC work to private companies.

As director of the Sunshine Project, which is now defunct, Hammond spent years pressing institutions for minutes from institutional biosafety committee meetings, which NIH requires be made available upon request. Some of the institutions he contacted could not provide them, he said. “The IBCs didn’t exist at a lot of institutions. They hadn’t met in years. They weren’t doing the oversight business. The system was just a complete farce.”

Shortly before the reconstruction of the 1918 flu virus, Hammond’s Sunshine Project published a report that singled out Mount Sinai for criticism, alleging that the institution had no IBC minutes. Earlier this year, for an investigation published by Undark, journalist Michael Schulson asked eight institutions in the New York area for IBC minutes. Mount Sinai did not provide them, Schulson told The Intercept. Mount Sinai also did not respond to a request to provide minutes to The Intercept.

The documents reviewed by The Intercept show broad variation in how seriously scientists and biosafety officers treated errors and accidents. In one report, a principal investigator apologized profusely after his IBC approval expired in the chaos of the early pandemic and his lab continued with research without renewing it. “This is completely my (PI) fault,” he wrote. “I failed my role as an effective PI this time.”

In other cases, staff appear eager to avoid responsibility. After a 2020 incident in which a researcher at the University of Wisconsin–Madison pricked themselves with a needle while working in a biosafety level 3 lab with a mouse infected with Mycobacterium tuberculosis, a biosafety officer blamed the accident on the mouse, writing, “The root cause is the natural instinct of an animal to be uncooperative with a procedure it dislikes.” (The officer wrote that “incomplete restraint” techniques contributed to the accident.)

In responding to violations, NIH can ask for changes or corrective action — and in some cases, the agency did. It can also pull funding if the guidelines aren’t met. But in 18 years of documents, The Intercept found no evidence of such extreme measures being taken. In one instance, NIH threatened to terminate funding after two incidents in a University of Wisconsin–Madison lab working with modified H5N1 avian influenza; the standoff ended with the institution adopting stricter protocols.

Regulators intent on preventing future pandemics are now exploring changes to biosafety policies. The issue has been taken up by Congress, the White House, the World Health Organization, and NIH itself. But the discussion is highly politicized, with some scientists resisting regulation and some experts pessimistic that the process will lead to real change.

One problem is a dearth of information. “We don’t have a clear picture of all accidents,” said Filippa Lentzos, an expert on biosecurity and biological threats at King’s College London. “It’s difficult to get good information on how risky stuff is, and how likely it is that you’re going to have an accident. We simply don’t have that data.” News of severe breaches sometimes leaks out in press reports. But many lab workers are graduate students. For them, speaking up about safety problems could mean career suicide.

The new documents fill in some of those gaps. While the researcher at Mount Sinai did not fall ill, in a small number of cases, accidents did lead to infection. In one instance, a researcher at Washington University of St. Louis contracted Chikungunya virus, which has sparked epidemics in Africa, after pricking herself with a needle in a biosafety level 3 lab. She only reported the accident after getting sick.

With pathogens like the 1918 flu virus, the stakes are even higher. The current system “gives a good level of review most of the time,” Bloom said. “But it’s not the kind of system that you could count on if you potentially have research that could kill 10 million people if it goes wrong.”

“There’s a lot of responsibility that comes with doing these experiments that are so high-risk,” says Lentzos. “It’s about talking through some of that. That is the biggest loophole that needs to be addressed.”

The post Accident With 1918 Pandemic Virus Raises Questions About Pathogen Research appeared first on The Intercept.

The New York Times ran an editorial titled “An Engineered Doomsday.” The backlash was so severe that in 2012, Kawaoka, Fouchier, and other prominent flu scientists voluntarily agreed to pause the transmissibility work. The debacle prompted an overhaul of policies, now being reconsidered in the wake of the coronavirus pandemic, governing work with so-called gain-of-function research of concern.

The story is well known. And yet, what happened next has never been reported in its entirety.

Early on, Fouchier told Science that he had created “probably one of the most dangerous viruses you can make.” But after controversy broke out, as the science communicator Peter Sandman has written, Fouchier and his supporters shifted to downplaying the danger. In early 2013, flu scientists ended their voluntary pause, arguing that when the research was done at enhanced biosafety level 3, or BSL3+, the benefits outweighed the risks. Kawaoka, who was normally the more taciturn of the two, hosted journalists in his lab, where he explained his safety procedures. “The influenza virus is sensitive to detergent,” he reportedly said while explaining the process of showering out. “They die.” A biosafety staffer at the University of Wisconsin got up before a university audience to dispel what she called myths about lab oversight. The address was broadcast on local television.

Then, months later, Kawaoka’s lab saw two accidents involving lab-generated flu viruses, just one week apart.

The accidents, a spill and a needle prick, carried a low risk of infection. Flu viruses are typically transferred through respiratory droplets, not skin contact or injection. Nonetheless, in letters obtained by The Intercept, staff at a funding agency accused the university of shirking biosafety precautions that Kawaoka had promised to adopt. They also demanded changes to the University of Wisconsin–Madison’s protocol for accidental lab exposures. Of particular concern was a plan to quarantine all researchers exposed to modified H5N1 at home, even if they were at high risk of infection — an approach that the funding agency administrators found so alarming that they threatened to end the lab’s grant unless the university changed course.

At the center of the debacle was the National Institutes of Health, whose National Institute of Allergy and Infectious Diseases had funded both Kawaoka’s and Fouchier’s labs. (Fouchier was a sub-awardee on a grant to a U.S. institution.) The agency oversees biosafety protocols on the same research it funds, and its oversight arm has a reputation for being timid, generally resolving issues through polite dialogue. “We want to be cautious about when we use that stick,” said Jessica Tucker, acting deputy director of NIH’s Office of Science Policy, referring to the threat of termination.

Under NIH’s guidelines on research with recombinant DNA, home quarantine is acceptable for low-risk H5N1 exposures, like the two 2013 accidents, but not for high-risk ones in which a scientist has potentially inhaled the virus. The guidelines say that lab workers exposed through their respiratory tract or mucous membranes need to be isolated in a dedicated facility, like a hospital.

With pathogens like modified H5N1, quarantining an exposed lab worker in such a facility is “a prudent precaution and reduces the risk to the worker’s family and community if they do become infected,” wrote Gregory Koblentz, director of the Biodefense Graduate Program at George Mason University’s Schar School of Policy and Government, in an email.

The University of Wisconsin–Madison did not have such a plan in place, according to the documents. In a letter to NIH, a university vice chancellor wrote that after consulting health care providers and Wisconsin health officials, administrators had determined that “a home quarantine was appropriate for all exotic influenza viruses.” Rebecca Moritz, who was with the University of Wisconsin–Madison’s Office of Biological Safety at the time, told The Intercept that the outside health experts were concerned that quarantining researchers in the hospital would put medical staff at risk and unnecessarily take up an isolation bed.

NIH alleged in a letter that university officials also worried about “the stress [hospital quarantine] would place on the laboratory worker.”

“That is not a persuasive argument,” said Richard Ebright, a molecular biologist at Rutgers University who sits on his university’s institutional biosafety committee. “Most major hospitals have an infectious disease isolation ward with rooms that are expressly designed to reduce transmission. No homes do.” In a hospital, he added, “[Quarantine] is supervised, which is not happening for a person in a home.”

Although the scientific community was debating how to oversee gain-of-function research, and the accidents would have been relevant to that debate, the dispute was handled quietly. One incident came to light 18 months later, the second emerged only last year, and the full story has gone untold until now.

Lack of Clear Standards

Descriptions of the two incidents, along with the agency’s responses, appear in the trove of documents obtained by The Intercept, Edward Hammond, and Lynn Klotz detailing lab accidents reported to NIH’s Office of Science Policy over a span of 18 years. The documents, which number over 5,500 pages, cover the years 2004-2021 and paint a picture of various animal bites, escapes, needlesticks, equipment malfunctions, and even some human infections. Hammond, former director of the now-defunct transparency group Sunshine Project, and Klotz, senior science fellow at the Center for Arms Control and Non-Proliferation, requested some of the documents under the Freedom of Information Act; The Intercept requested others directly.

When the University of Wisconsin reported the two incidents to NIH’s Office of Science Policy, as required of institutions that use NIH funding to research certain pathogens, it set off a flurry of heated conference calls and sternly worded letters involving high-level administrators on both sides. The spat lasted six weeks.

Kawaoka and the university had assured the world that his research was safe, but NIH alleged that they were not adhering to all regulations, and even in some cases to the university’s own policies. “NIH has significant concerns regarding the biosafety practices associated with both of the recent incidents,” two agency officials wrote in one letter. They threatened to “institute enforcement action(s),” including suspending or terminating Kawaoka’s grant.

The agency’s reaction to the accidents was more extreme than in any other instance examined by The Intercept. After many other accidents, including for some involving potential pandemic pathogens, the same bureaucrats responded with brief thank-you emails. In a few cases, they asked for corrective actions. In no other instance did they threaten to withhold funding.

Withholding or terminating funding “remains the agency’s last measure for compliance and thus the agency tries to prioritize the other tools at our disposal to achieve our policy goals as a first measure,” wrote Ryan Bayha, a spokesperson for NIH’s Office of Science Policy, in an email. “These include working with researchers and other institutional officials to help bring the researcher back into compliance. In our experience, this has been a successful approach.” (Bayha was previously an analyst with the office, and the initial report of the needle prick went to him, along with other staffers.)

In some instances, the University of Wisconsin–Madison biosafety practices singled out for scrutiny by the agency aren’t clearly delineated in agency guidelines. The dispute highlights a lack of clear standards in how to respond to exposures in high-risk labs — a gray area that, critics argue, could put the public in danger. “It shouldn’t be up to people in the moment of a disaster,” said Rocco Casagrande, managing director of Gryphon Scientific, a biosafety advisory firm. “Someone needs to step in and say, ‘This is how it should be.’”

The needle prick was previously reported by USA Today, as part of a larger investigation into U.S. biolabs. Klotz wrote about the two accidents in an article for the Bulletin of the Atomic Scientists last year. The Intercept is publishing the full correspondence between NIH and the University of Wisconsin–Madison about the breaches, along with additional details and reporting, for the first time. (The Intercept has omitted one document to protect the lab’s security.)

“The Influenza Research Institute has never experienced an event where public health or safety has been put at risk,” wrote Andrea Ladd, director of biological safety at the University of Wisconsin–Madison, in an email to The Intercept. “This does not mean incidents do not occur, but when they do, there are protocols and systems in place to ensure that risk is mitigated and our researchers, community, and environment are protected from harm.”

“No one that is currently at UW-Madison was involved in those conversations with the NIH and therefore we cannot confirm details of those conversations,” she added. But she wrote that before NIH intervened, home quarantine was the university’s policy “in most cases” following exposure to highly pathogenic avian flu viruses like H5N1: “Examples of when quarantine would have been at a location other than a personnel residence were not specified in the UW Exposure Control Plan prior to December 2013.” The university currently quarantines high-risk exposures in an isolation room at a local hospital, she said.

Ladd wrote that unlike in the bombshell avian influenza studies, the two strains at issue in the accidents were “not known to be mammalian transmissible.”

Critics counter that Kawaoka’s research entailed stitching genes from H5N1 onto human flu strains and adding progressively more mutations until the hybrid viruses became transmissible, and that, while risk is hard to predict, strains along that continuum could also be concerning. “If it is a version that is on the pathway toward mammalian transmission, more than strains that circulate in nature, then it is a subject of high concern,” said Ebright. According to the documents, one of the strains had a mutation in the receptor binding site, which is critical to infection.

Fouchier declined to comment, writing in an email, “I have commented many times in the past.” Kawaoka confirmed the accuracy of Ladd’s responses but declined to respond to questions. Shortly after publication, he wrote in an email that “on rare occasions, humans become infected with avian influenza viruses, usually following close or prolonged contact with infected birds. The mutation in question was found in a patient sample and is not known to be mammalian transmissible. We did not test the transmissibility of the virus in question or use this virus for any animal experiments.”

“Dr. Kawaoka is one of most compliant, if not the most compliant PIs [principal investigators] I have ever worked with,” said Moritz, who was with the University of Wisconsin–Madison’s Office of Biological Safety at the time. “He takes safety and security incredibly seriously and works very, very well with people like me to figure out how to mitigate risk.” She added: “One of the things that I find most disheartening about this entire debate is that we’re debating the ethics of a set of experiments. That’s what we’re ultimately debating.”

Others agree that the accidents were not unusual or reckless but contend that when it comes to experiments with a small but real chance of ravaging the population, safety and ethics are inextricable. “We should be brave enough to say that some experiments should not be done,” said Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris who supported restrictions on controversial gain-of-function research in the wake of the 2011 studies. Because such work accounts for a small proportion of biomedical science, he argued, “This is not an attack on the scientific system. It is about protecting the integrity of the scientific system and society as a whole.”

A Punctured Glove

When flu viruses reassort, or swap gene segments, in nature, the hemagglutinin gene often plays a critical role. For the controversial 2011 experiments, Kawaoka’s team had combined a mutated version of the hemagglutinin gene from an avian H5N1 strain with gene segments from a human H1N1 flu strain. They used a similar approach to generate one of the viruses at issue in the 2013 accident reports, though with a different strain of H5N1 and fewer mutations in the hemagglutinin gene. On a Saturday evening that November, a researcher in Kawaoka’s lab was using a needle to draw up liquid containing the virus when he pricked his hand. The needle punctured his glove, sinking into his finger.

The researcher dialed the on-call lab manager, who gave detailed instructions on what to do next: Squeeze blood out of the wound, run his hand under water for 15 minutes, put on new gloves, clean up, and shower out. After notifying health care providers and other staff, the lab manager gave the researcher Tamiflu, an N95 mask, and a new glove to cover his injured hand; the laboratory manager drove the researcher home, instructing him to quarantine there for a week. A colleague had called ahead and told the researcher’s family members to pack their things so they could be moved to a hotel before he arrived. A university employee alerted city and state health officials. Once home, the researcher started taking his temperature, and the next morning the lab manager collected throat and nose swabs for testing. Soon after, a biosafety officer informed NIH about the accident, boasting: “This has been an exceptional response.”

Administrators at the Office of Science Policy disagreed. A week earlier, a researcher in the same lab carrying a stack of tissue culture plates containing a different modified H5N1 strain dropped a plate, spilling a small amount of virus onto the lab floor. Some of it splashed onto his Tyvek suit, just below the knee. From there, the suit extended down his legs and then stopped at his ankles, leaving patches of bare skin. The researcher cleaned up the accident; doused his arms, legs, and some lab equipment in an ethanol solution; stuffed all of the waste into a biohazard bag; and phoned the on-call scientist to report what had happened. After consulting a doctor and getting him a prescription for Tamiflu, biosafety staff discharged the researcher, telling him to monitor his body temperature. After he left the lab, a second researcher went in to dispose of the waste.

As NIH staff pried into the University of Wisconsin’s policies for research on avian influenza viruses, they learned that the institution planned to quarantine exposed researchers at home in all cases, no matter the risk level. “An individual’s permanent residence is not appropriate due to the fact that many residences are in buildings with high occupancy that share air exchange and other infrastructure,” wrote Jacqueline Corrigan-Curay, an official in the Office of Science Policy, in a December 2013 letter to the university. She pointed out that in a research plan sent to NIH earlier that year, Kawaoka had said he had access to a “designated quarantine apartment” for researchers who were at high risk of infection. (Ladd told The Intercept that Kawaoka’s statement about the apartment was caused by a “misunderstanding” between him and the university on where researchers would quarantine after high-risk exposures.)

Corrigan-Curay ordered the university to find a dedicated quarantine facility, noting, “An isolation room in a hospital would be appropriate.”

NIH also noted that the exposed researcher had been using the needle for an unauthorized purpose; the laboratory’s standard operating procedure did not allow needles to be used for drawing up tissue culture supernatant, the liquid the researcher had targeted. (Ladd said that the policy has since been “revised for improved clarity” and that the lab workers were retrained.)

In the spill, NIH took issue with the researcher’s exposed ankles. Agency officials contended that bare skin violated the agency’s guidelines covering research with recombinant DNA.

On a phone call, university representatives disagreed. According to a note about the call in the correspondence, someone said that the lab had recently been inspected by the Select Agent Program, which is jointly administered by the U.S. Department of Agriculture and the Centers for Disease Control and Prevention, and that the report from the inspection did not mention any restrictions of the sort on bare skin.

NIH shot back that the agency had consulted staff at the Select Agent Program. “They are in agreement that bare skin is unacceptable at this level of containment,” wrote Corrigan-Curay. “The University must take immediate action to ensure that, in the future, no workers in this or any other high containment laboratories have exposed skin.”

The dispute over bare ankles illustrates a lack of clear and consistent standards. In Canada and select other countries, research on pathogens is centrally regulated. The United States has a jumble of policies, and biosafety training can vary widely from one lab to the next. After the uproar over the 2011 avian influenza studies, NIH adopted additional biosafety guidelines for research with H5N1 strains that are transmissible in mammals, but even those are not comprehensive.

“They don’t have good guidelines about when things are mitigated enough,” said Casagrande, whose firm has advised NIH on the risks and benefits of gain-of-function research. “They can have one response that is guns blazing, and another that is very muted — and why? What’s the standard?”

“Clearly, [oversight] only happens in extraordinary cases,” said Koblentz, the biosafety scholar. “But really it should be the routine.”

“Cannot Have More Accidents”

The exchange may have been particularly heated because the accident occurred at a fraught moment for high-risk viral research. H5N1 belongs to a group of what are called “potential pandemic pathogens”: bacteria, viruses, and other microorganisms that, either through handling or through modification, could set off another pandemic. Policies governing research with such pathogens were established in the wake of Kawaoka’s and Fouchier’s controversial papers, which were published with some revisions by Nature and Science, respectively, in 2012. (Klotz, who provided The Intercept with the University of Wisconsin incident reports, coined the term “potential pandemic pathogen” with Edward Sylvester of Arizona State University.)

In 2014, the U.S. government adopted a moratorium on funding for gain-of-function research that could spark a pandemic. Three years later, the pause was lifted and the Department of Health and Human Services, NIH’s parent agency, shifted to a framework called P3CO, under which research that involves modifying potential pandemic pathogens or is “reasonably anticipated” to create them has to undergo a special review process in order to get funding.

Neither policy has been evenly or transparently implemented. The Intercept has reported that in 2016, National Institute of Allergy and Infectious Diseases administrators flagged a proposal by EcoHealth Alliance, a U.S. nonprofit that worked with the Wuhan Institute of Virology on bat coronavirus research, as potentially being covered by the moratorium. But instead of insisting on modifications that would have made the research safer, they let the organization craft an unusual rule to govern its own work. Since the P3CO policy was adopted in 2017, according to Health and Human Services, only three projects have undergone special review. In a detailed analysis of NIH’s grant database last year, the Washington Post identified a total of eight projects that appear to have warranted review. And just last month, in articles from Stat and Science, it emerged that two more risky experiments had not undergone review. In the first instance, at Boston University’s National Emerging Infectious Diseases Laboratory, scientists created a hybrid version of SARS-CoV-2, the virus that causes Covid-19. The National Institute of Allergy and Infectious Diseases alleged that they had not sought approval for the work, prompting scientists not connected with the experiments to point out that the guidance on when to seek approval is unclear.

Moritz, the former University of Wisconsin–Madison biosafety staffer, contended that NIH’s response to the 2013 accidents was overblown and driven by the gain-of-function controversy. “You need to look at the timeframe and the context of what was going on politically,” said Moritz, who is now biosafety director at Colorado State University and the incoming president of ABSA International, a biosafety professional association. “That’s why the reaction was the way it was.”

“These decisions are not made politically,” said Tucker, the Office of Science Policy acting deputy director. “They’re made in terms of the best response and working with institutions to come into compliance.”

After NIH threatened to terminate Kawaoka’s grant, the documents show, the University of Wisconsin overhauled its policies, agreeing to adopt new guidelines on quarantining and on exposed ankles. The university sent the agency copies of new training slides. One conveyed a mixed message to lab workers. “Cannot have more accidents,” read one. “But MUST report any incidents, even the most minor.”

The researcher who had spilled the plate containing modified H5N1 got up in front of his fellow lab workers and reenacted the accident. Staff peppered him with questions. “Did you ever have a moment when you panicked?” asked one. “What was your worst fear? Quarantine?” asked another. The university sent notes on the meeting to NIH.

Finally, the two sides reached an agreement. On Christmas Eve in 2013, NIH wrote in a letter to the University of Wisconsin associate vice chancellor that the university had complied with its demands. Kawaoka’s lab could resume the controversial work.

Weak and Nonspecific

Today, research with potential pandemic pathogens is again in the spotlight. In February, NIH charged a committee called the National Science Advisory Board for Biosecurity with reconsidering the P3CO policy, along with a policy on dual-use research. The NSABB has a fraught history, and its members are appointed by NIH itself. “There is an inherent conflict of interest in having a group appointed by an agency to review that agency’s work,” said Koblentz.

At NSABB meetings in April and September, tensions ran high. At stake is not just the future of gain-of-function research, some participants stressed, but the safety of the world. And yet, lost in the discussion is the fact that one of the labs that set off the gain-of-function fracas actually has had accidents involving modified H5N1.

When lab accidents happen, “They don’t put it in the local newspaper, and I think it’s reasonable that they don’t,” said Stuart Newman, a cell biologist at New York Medical College who sits on his university’s institutional biosafety committee. “But because it’s all handled quietly, the general public isn’t aware of the frequency of incidents like this — or even that they exist.” Even though most incidents don’t lead to infection, Newman said, “Just the fact that they happen should be more widely known.”

The NSABB released preliminary recommendations last month. Critics say they’re incomplete. At the meeting where the results were unveiled, Harvard University epidemiologist Marc Lipsitch took issue with the section of the recommendations that deals with transparency, saying, “It’s too weak and too nonspecific.” Tucker said the final recommendations are expected in December or January.

Some biosafety advocates say that a broader overhaul is needed. “As long as all of the oversight is strictly advisory and none of it is enforceable with force of law, nothing ever will move forward — particularly so long as the oversight is housed in an institution that performs and funds research,” said Ebright. “It needs to come from Congress or the White House.”

One model for regulating pathogen research could be the Nuclear Regulatory Commission, which oversees all facilities that work with radiological materials and also funds research on safety and security.

Others say that nothing short of a dramatic shift in worldviews is needed. Jesse Bloom, an evolutionary virologist at Fred Hutchinson Cancer Center, compared it to research on human subjects. Until the 1970s, scientists regularly carried out experiments on prisoners, including for infection studies. Over time, opinions shifted. “At some point, it became accepted that even though experiments on prisoners were scientifically informative, they just aren’t ethical to do,” said Bloom.

For the rest of the world, how the United States regulates research with dangerous pathogens matters. “The United States has a special responsibility when it comes to oversight and getting it right,” said Filippa Lentzos, an expert on biosecurity and biological threats at King’s College London who co-chairs an international task force on high-risk pathogens with Bloom. “It is a leader in a lot of this research, and it’s where most of this research takes place.”

In 2014, the moratorium on gain-of-function work made it impossible for Kawaoka’s lab to continue with transmissibility studies. But five years later, Science reported that the Health and Human Services P3CO panel quietly greenlighted the controversial bird flu experiments to resume, without alerting the public. The agency did not release details on how the panel assessed the proposals or what evidence was evaluated. The grant was contingent on the lab following additional safety measures, but the agency did not announce what these were. The decision came to light only because word leaked to a journalist, a fact that two prominent experts writing in the Washington Post called “unacceptable.”

The 2013 accident reports and correspondence might have helped inform the discussion. But at that point, they weren’t public.

Update: November 2, 2022

This article has been updated with a comment from Yoshihiro Kawaoka that was received after publication.

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