Lab-created bird flu virus accident shows lax oversight of risky ‘gain of function’ researc
Allison Young
USA Today
Inside the high-security Influenza Research Institute at the University of Wisconsin-Madison, two experienced scientists were pulling ferrets out of their HEPA-filtered cages on a Monday in December 2019. Another researcher, still in training, was also in the room to watch and learn.
One by one, the animals were put into a biosafety cabinet, where a solution was washed into their nostrils. It’s a procedure used to collect evidence of infection, and this particular experiment involved exposing the animals to a highly controversial lab-engineered strain of H5N1 avian influenza virus.
The virus they were working with that day was far from ordinary, and there should have been no room for the safety breach that was about to happen and the oversight failures that followed.
The experiment underway involved one of two infamous lab-made bird flu viruses that had alarmed scientists around the world when their creation became widely known nearly a decade earlier. In each case, scientists had taken an avian influenza virus that was mostly dangerous to birds and manipulated it in ways that potentially increased its threat to humans.
In nature, the H5N1 virus has rarely infected humans. But when people have been sickened, usually through close contact with infected birds, more than half died. So it is fortunate that the H5N1 virus isn’t capable of spreading easily from person to person. If the virus were ever to evolve in ways that gave it that ability, it could cause a devastating pandemic.
‘Gain of function’ research created controversial flu viruses
And yet in late 2011 the world learned that two scientific teams – one in Wisconsin, led by virologist Yoshihiro Kawaoka, and another in the Netherlands, led by virologist Ron Fouchier – had potentially pushed the virus in that direction. Each of these labs had created H5N1 viruses that had gained the ability to spread through the air between ferrets, the animal model used to study how flu viruses might behave in humans.
The ultimate goal of this work was to help protect the world from future pandemics, and the research was supported with words and funding by two of the most prominent scientists in the United States: Dr. Francis S. Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases.
Kawaoka contended it would be “irresponsible not to study” how the virus might evolve in nature. “Some people have argued that the risks of such studies – misuse and accidental release, for example – outweigh the benefits. I counter that H5N1 viruses circulating in nature already pose a threat,” he said at the time.
Yet these groundbreaking scientific feats set off a heated international debate over the ethics and safety of “gain of function” research. The controversy continues to this day.
Concerns about the safety of biological research have taken on heightened urgency in the wake of the COVID-19 pandemic and growing acceptance of the possibility that it was caused by a lab accident in China. In February, it was revealed that analysts at the U.S. Department of Energy had joined the FBI in leaning toward a lab accident as the most likely source of the pandemic, though other U.S. intelligence agencies lean toward a natural origin or are undecided.
The story of how the H5N1 viruses came to be created – and how the University of Wisconsin and the Kawaoka lab would later respond to the 2019 safety breach during the ferret experiment – raises uncomfortable questions about the tremendous trust the world places in these kinds of labs.
We are trusting that every hour of every day their layers of laboratory containment equipment are working properly, that all of their employees are sufficiently trained, qualified and attentive, and that their written safety and incident response protocols are followed in real-life practice.
When something goes wrong, we are trusting that the labs will immediately notify local public health officials who are responsible for preventing outbreaks and the federal authorities who oversee the safety of experiments with genetically engineered organisms.
Given that so much about this work is shrouded in secrecy, what happened in Wisconsin raises the question: Should the public give this trust blindly?
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Scientist’s air hose detached in lab while working with engineered virus
When the accident happened on Dec. 9, 2019, Kawaoka’s three scientists were working in an enhanced biosafety level 3 agriculture lab suite at the University of Wisconsin’s Influenza Research Institute.
This facility had been built specifically for Kawaoka’s research and featured labs with negative air pressure, watertight and airtight seals, double HEPA-filtered exhaust air and redundant air handling systems.
The experiment they were performing involved a virus whose name describes the components of its engineering: VN1203HA(N158D/N224K/ Q226L/T318I)/CA04. It was the virus described in Kawaoka’s controversial H5N1 gain-of-function experiments that had been published nearly eight years earlier, the NIH would later confirm in written responses to my questions.
It was the virus that had gained the concerning ability to spread between ferrets and had raised fears it could do this among humans.
On that December day, two experienced researchers from Kawaoka’s team were helping train a colleague as they collected samples from ferrets. The animals were part of a transmission experiment and had been in contact with other ferrets infected with this engineered H5N1 virus or another wild-type flu strain.
The three scientists wore several layers of personal protection equipment. One of their most important pieces of personal protective equipment was the air-purifying respirator that each wore to ensure they didn’t breathe any air from inside the the laboratory. Even though they were using a biosafety cabinet, there was always the potential for virus to be present in the room’s air.
These kinds of high-tech respirators encase workers’ heads in a protective hood with a clear face-plate. A blower attached to a belt delivers purified air through what looks like a vacuum cleaner hose that runs up the scientist’s back and attaches to the hood behind their head.
Labs are responsible for training workers how to properly assemble and use this kind of equipment.
As one of the senior researchers prepared to start collecting samples from the next round of ferrets, the trainee realized there was a problem with their respirator.
The powered air-purifying respirator (PAPR) hose had somehow disconnected from the unit that supplied safe, filtered air. Instead, the detached hose dangled loose in the lab’s potentially contaminated air.
The hose was “immediately” reconnected, Wisconsin officials later said, and one of the experienced researchers radioed out to the lab’s operations manager as the trainee began the process of exiting the lab, incident records show.
The trainee was initially told to follow the lab’s quarantine procedure to keep them spreading the virus if they were infected. The university would later say this was done “out of an abundance of caution.” But at some point, a lab compliance official released the worker from quarantine.
It is unclear whether this quarantine release happened within minutes, hours or days of the incident. Nor is it clear whether university officials first consulted with any public health and oversight agencies.
Kawaoka and university officials wouldn’t agree to be interviewed and provided little information in response to my questions.
State and local health officials weren’t notified about lab accident
If there were ever a virus requiring that everyone follow safety and incident reporting rules, this was it. The system of oversight in place that day had been created in response to the international furor over this very virus.
Yet, after the trainee’s respirator hose disconnected in December 2019, the university didn’t notify local or state public health officials about the incident or consult with them before discontinuing the trainee’s quarantine, despite representations going back years indicating this would occur following “any potential exposure.”
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