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Researchers' tests of the lab-made version of the Covid virus are under review

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RResearch involving testing a lab-made hybrid version of the SARS-CoV-2 virus at Boston University is garnering heated headlines claiming that scientists involved may have unleashed a new pathogen.

There is no evidence of inappropriate or unsafe work performed within the scope of biosafety level 3 measures at BU’s National Emerging Infectious Diseases Laboratories. In fact, the university said Monday night that it has been approved by an internal biosafety review committee and the Boston Public Health Commission.

However, it turned out that the research team did not clarify its work with the National Institute of Allergy and Infectious Diseases, one of the project’s funders. The agency said it will seek some answers as to why it first learned of the study from media reports.

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Emily Erbelding, director of NIAID’s microbiology and infectious diseases division, said the IB team’s original grant applications did not indicate that the scientists wanted to do this definitive work. Nor did the group make clear in its progress reports to NIAID that it is conducting experiments that could involve the development of a potential pandemic pathogen.

“I think we’ll talk about it in the coming days,” Erbelding said in an interview with STAT.

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Asked whether the research team should inform NIAID of its intention to do this work, Erbelding said, “We wish they did, yes.”

The research has been published online as a preprint, meaning it has not yet been peer-reviewed. The senior author is Mohsan Saeed of BU’s National Emerging Infectious Diseases Laboratories. STAT reached out to Saeed on Monday but received no response at the time this article was published.

In emailed comments, the university later disputed claims by some media outlets that the study created a more dangerous virus.

The email from Rachel Lapal Cavallario, vice president of public relations and social media, said the study was not a function research winner that allegedly refers to manipulation to make pathogens more dangerous. “Actually, this research virus [replication] less dangerous,” the e-mail said, adding that other research groups are conducting similar studies.

Saeed and colleagues report on their research, which involved creating a hybrid or chimeric virus, in which the spike protein of an Omicron version of SARS-2 fuses into a virus of the Wuhan strain, the original version originating in China. Omicron viruses first appeared in late 2021 and have since split into multiple different sub-variants.

The purpose of the research was to determine whether mutations in the Omicron spike protein were responsible for the increased ability of this variant to evade human immunity against SARS-2, and whether the changes resulted in a lower severity rate of Omicron.

Tests actually showed that the chimeric virus was more lethal to one type of laboratory mouse than Omicron itself, killing 80% of infected mice. More importantly, the original Wuhan strain killed 100% of the mice it was tested on.

The conclusion of the study is that mutations in the spike protein of the Omicron variant are responsible for the strain’s ability to evade the immunity that humans have built up through vaccination, infections, or both, but not for the marked reduction in disease severity. Omicron viruses.

“Consistent with studies published by others, this study shows that it is not the spike protein that drives Omicron pathogenicity, but rather other viral proteins. Identifying these proteins will lead to better diagnostic and disease management strategies,” he said.

Research into the potential to make pathogens more dangerous has been a hot topic for years. Nearly a decade ago, a high-profile debate over whether it was safe to publish controversial studies on the dangerous bird flu virus, H5N1, led to a rewriting of the rules around such studies. Another review of the policy is currently led by the National Biosafety Science Advisory Board.

Controversy around research into potential pandemic pathogens has gained ground since the beginning of the Covid-19 pandemic, which some scientists and others believe may be an accidental or deliberate result of research on bat coronaviruses at the Wuhan Institute of Virology in China. The city where the epidemic is believed to have started. (There is plenty of evidence to suggest that the virus originated from a wet market in the city and not from the Wuhan lab. But proving that something didn’t happen three years later is a challenge that may be impossible to overcome.)

According to NIAID’s policy, proposals to undertake federally funded research capable of producing so-called advanced pathogens of pandemic potential should be referred to a committee that will evaluate the risks and benefits of the study. The policy is known as the P3CO framework.

Erbelding said that if Saeed’s team had known that it was planning to develop a chimeric virus, then NIAID would likely have convened such a committee.

“What we would have wanted to do was talk upfront about exactly what they wanted to do, and if it meets what the P3CO framework defines as an advanced pathogen of pandemic potential, we could come up with ePPP, a package for review. committee convened by HHS, the office of the assistant secretary for preparedness and response. The framework reveals that, and that’s how we would have done it.”

But Erbelding noted that some of the media coverage of the study overestimated the risk that the study might have posed. “That 80% kill rate, this headline doesn’t tell the whole story,” he said. “Because Wuhan” – the original kind – “killed all the rats.”

The death rate seen in this strain of mice when infected with these viruses raises questions about how good a model they are for what happens when humans are infected with SARS-2. The Wuhan strain killed less than 1% of infected people.

Virologist Angela Rasmussen, who was not involved in the research, had some sympathy for IB scientists, saying there was ambiguity in the rules as currently written.

“Since much of the definition of EPPP is about ‘reasonably predicting’ outcomes in humans (and animal models are not always good proxies of this), it’s very difficult for researchers to say, ‘Oh yeah, that’s ePPP,'” Rasmussen wrote. In response to STAT’s questions.

“When in doubt I would personally seek clarification from NIAID, but it is often not clear when additional guidance is required. And because it’s not very transparent, it’s hard to look at other decisions by NIAID for samples,” he said.

“I’m so sick of 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 Vaccine and Infectious Diseases Organization. “That’s not the problem. The problem is that for many experiments, the guidelines and expectations are not clear and the process is not transparent.”

— This article has been updated to include comments from Boston University and the article’s senior author.

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