Research at Boston University that referred to testing a lab-made hybrid edition of the SARS-CoV-2 virus is making headlines claiming that the scientists involved may have triggered a new pathogen.
There is no evidence that the work, conducted under Level 3 biosecurity precautions at BU’s National Emerging Infectious Disease Laboratories, was conducted in an off-site or unsafe manner. In fact, it was approved through an internal biosafety review committee and the Boston Public Health Commission, the university said Monday night.
But it has become transparent that the studies team did not allow the paintings with the National Institute of Allergy and Infectious Diseases, which is one of the project’s sponsors. The firm said it would seek answers as to why it learned of the paintings through media reports.
Emily Erbelding, director of NIAID’s Division of Microbiology and Infectious Diseases, said the BU team’s initial grant programs did not specify which scientists were looking for to do this work quickly. The organization also did not specify that it would conduct experiments that might involve improving a pathogen. with pandemic foresight in the progress reports it provided to NIAID.
“We’re going to have conversations in the next few days,” Erbelding told STAT in an interview.
When asked if the studies team had informed NIAID of their goal to do the work, Erbelding replied, “I wish they had, yes. “
The studies were published online as a preprint, meaning they have not yet been peer-reviewed. The leader is Mohsan Saeed of BU’s National Laboratories for Emerging Infectious Diseases. STAT reached out to Saeed on Monday but did not get a reaction at press time.
In emailed comments, the university later questioned claims through some media that the paintings had created a more harmful virus.
The email, from Rachel Lapal Cavallario, associate vice president of public relations and social media, said the paintings are not, as claimed, gain-of-function studies, a term that refers to manipulating pathogens to make them more dangerous. “In fact, these studies have made the [replicating] virus less dangerous,” the email said, adding that other study teams have done similar work.
In the paper, Saeed and colleagues reported on studies they conducted related to the creation of a hybrid or chimeric virus, in which the spike protein from an Omicron edition of SARS-2 fused with a virus of the Wuhan strain, the original edition that emerged from China in 2020. Omicron viruses first appeared in late 2021 and have since split into several other subvariants.
The purpose of the studies was to determine whether mutations in the Omicron spike protein were to blame for this variant’s increased ability to evade immunity to SARS-2 that humans have accumulated, and whether the adjustments led to a decrease in Omicron’s severity rate.
Tests showed, however, that the chimeric virus was more lethal to a type of lab mouse than Omicron itself, killing 80 percent of the inflamed mice. Importantly, the original Wuhan strain killed 100% of the mice it was tested on.
The conclusion of the study is that mutations in the Omicron variant spike protein are to blame for the strain’s ability to evade immunity that other people have built up through vaccines, infections, or both, but they are not to blame for the minimal obvious severity of Omicron. virus.
“According to studies published by others, this painting shows that it is not the spike protein that drives the pathogenicity of Omicron, but other viral proteins. Determining those proteins will lead to better diagnostics and disease control strategies,” Saeed said. in an observation published by the university.
Research that can make pathogens more harmful has been a hot topic for years. About a decade ago, a high-profile debate over whether to publish questionable studies conducted on a harmful bird flu virus, H5N1, led to a rewrite of regulations related to this type of work. Another policy review, led by the National Scientific Advisory Council on Biotechnology, is being undertaken recently.
The controversy surrounding pathogen studies with pandemic prospects has gained momentum since the beginning of the Covid-19 pandemic, which some scientists and others would possibly have been the accidental or planned result of coronavirus studies in bats at the Wuhan Institute of Virology in China. city where the pandemic would have begun. (There is sufficient evidence that the virus is spreading from a rainy market in the city, not from the Wuhan lab. But proving that nothing happened 3 years after the fact is a challenge that is possibly very unlikely to overcome. )
Under the policy, which is administered through the Department of Health and Human Services, proposals for federally funded studies that could produce advanced pathogens with a pandemic perspective would have to be referred to an HHS committee that would evaluate the hazards and benefits of the work. . . The policy is known as the P3CO framework.
Erbelding said that if NIAID had known about the BU Group’s plans to spread a chimeric virus, it would most likely have conducted its own review to see if the matter would be referred to the HHS committee.
“What we would have liked to do is communicate to them exactly what they wanted to do ahead of time, and if that met what the P3CO framework defines as an enhanced pathogen with pandemic potential, ePPP, we may have proposed a package of care through the committee convened through HHS, the assistant secretary for preparedness and response. That’s what the framework says and that’s what we would have done,” he said.
However, Erbelding noted that part of the studio’s media policy overestimates the threat the paintings could have posed. “That 80 percent death rate, that headline doesn’t tell the full story,” he said. Original strain: “He killed all the mice. “
The mortality rate seen in this variety of mice when they were infected with those viruses raises questions about the quality of a style of what happens when other people become infected with SARS-2. The Wuhan strain killed less than 1% of those infected.
Virologist Angela Rasmussen, who was not involved in the research, was sympathetic to the BU scientists and said there was ambiguity in the regulations as recently drafted.
“Because so much of the definition of ePPP has to do with ‘reasonable anticipation’ of human outcomes (and animal models are not smart signs of that), it’s very difficult for researchers to say, ‘Oh yeah. , that’s ePPP’. ” Rasmussen wrote in reaction to STAT’s questions.
“I would personally seek an explanation from NIAID when in doubt, but it is not transparent when further guidance is needed. And because it’s not very transparent, it’s hard to take a look at other decisions made through NIAID to see examples,” he said.
“I’m very tired of other people suggesting that virologists and NIAID are reckless or don’t care about biosecurity,” said Rasmussen, a coronavirus expert at the University of Saskatchewan’s Organization for Vaccines and Infectious Diseases. “That’s not the challenge. The challenge is that the rules and expectations are not transparent for many experiments and the procedure is not transparent.
— Correction: An earlier edition of this article reported that the federal study surveillance program is administered through the National Institutes of Health. The Department of Health and Human Services administers the program.
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