BU lab not required to approve Covid study with NIH, director says

JThe director of a Boston University lab that has conducted potentially controversial research into the viruses that cause Covid-19 said his institution did not authorize work with the National Institutes of Health because he was not not funded by the federal agency.

Ronald Corley said the research, which was designed to explore what makes some SARS-CoV-2 viruses more pathogenic than others, was paid for with money from the university itself. The work was approved by the Institutional Biosafety Committee of BU’s National Emerging Infectious Diseases Laboratories and the Boston Public Health Commission.

Scientists at the BU facility have published the results of their work in a preprint, a study that has not yet been peer-reviewed. The British tabloid The Daily Mail published an explosive article on the works on Monday, suggesting that the group had made a more dangerous version of the SARS-2 Omicron variant.

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In response to a question from STAT, the National Institute of Allergy and Infectious Diseases, which had given two grants to the research group, said Monday that it should have been informed of the nature of the work beforehand, so that an assessment can be made. conducted.

Emily Erbelding, director of NIAID’s Division of Microbiology and Infectious Diseases, said it was the policy set out in what’s called the P3CO framework, which spells out work rules that could lead to improvement of dangerous pathogens.

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“What we would have wanted to do was talk about exactly what they wanted to do in advance, and if that met what the P3CO framework defines as an enhanced pathogen with pandemic potential, ePPP, we could have propose a package for review by the committee convened by HHS, the Office of the Assistant Secretary for Preparedness and Response. That’s what the framework provides and that’s what we would have done,” she said.

But the policy only applies to work of this type that is funded by the federal government. And NIAID money was not used for this research, Corley said.

Some of the NIAID funding has gone to work that could be considered fundamental to the research in question. Corley said the team used some of the federal funds to develop a plasmid-making system they would need to do the subsequent work.

He acknowledged that it can be difficult to see where the lines are drawn, when research groups use different pots of money to fund their work.

“It’s a murky world, but in our opinion, because the funding did not support the work that was supported in this paper, there was no need to report it to the NIH,” he said.

STAT asked NIAID if it was satisfied with Boston University’s response. The agency’s response, received by email Tuesday evening, did not directly answer the question, although it did say the situation is still under investigation.

“The NIH is reviewing the matter to determine whether the research conducted was subject to the NIH Grants Policy Statement or met the criteria for review under the HHS Framework to Guide Funding Decisions Regarding Proposed Research Involving Pathogens Enhanced Potential Pandemics (HHS P3CO Framework),” the statement said.

Corley also challenged the idea that the work done by scientist Mohsan Saeed and his colleagues was so-called “gain-of-function” research. The group created a hybrid or chimeric virus – in which the spike protein from an Omicron version of SARS-2 was fused to a virus from the Wuhan strain, the original version that emerged from China in 2020. Omicron viruses first appeared in late 2021 and have since splintered into several different subvariants.

The aim of the work was to see if mutations in the Omicron spike protein were responsible for the lower severity rate caused by Omicron viruses.

Tests actually showed, however, that the chimeric virus was more lethal to a type of lab mouse than Omicron itself, killing 80% of infected mice. But the original Wuhan strain killed 100% of the mice it was tested on. This suggests that the spike protein itself is not responsible for the pathogenicity of SARS-2 viruses, Corley said.

He noted that because the chimeric virus was less dangerous in mice than the original strain, this work could not be characterized as gain-of-function research. This is unlikely to appease critics of the work, who might argue that the Wuhan strain is not the right benchmark to use as a comparison, given that it is no longer circulating. The chimeric virus was more pathogenic than currently circulating SARS-2 viruses, which are variants of Omicron.

But it’s important to note that the severity of the mouse species used in the experiment does not reflect what happens in humans. All mice exposed to the original SARS-2 viruses died. Less than 1% of people who contracted these viruses died.

Corley said UB safety protocols require that if researchers produce a pathogen that is more virulent than the Wuhan strains, they must report it immediately to the Institutional Biosafety Committee. Saeed’s study protocol further stated that if such an event occurred, he would immediately stop work and destroy the viruses, Corley noted.

STAT approached Saeed for an interview but he did not respond to the request.

Corley said the study’s lead investigators — Saeed is one of two — spoke with their program managers at NIH on Tuesday.

“They support the work we’re doing and we certainly want to make sure we’re on comfortable ground,” Corley said.

— This article has been updated with a comment from the National Institute of Allergy and Infectious Diseases.

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