Researchers at Boston University in Massachusetts tried to understand why Omicron causes mild disease when they inserted a gene from the Omicron variant into a strain of the viruses.
The experiments, described in a 14 October preprint, have sparked a red-hot controversy over what constitutes truly risky SARS-coV-2 research, especially now that most of the world's population has some immune protection from the virus.
Even if the agencies didn't fund the experiments in question, researchers should keep regulators and funding agencies apprised of their work. Gain of function research is when a study makes a pathogen more transmissible.
The lack of clarity that people have on exactly what sorts of experiments have benefits that outweigh risks is highlighted by the BU study.
Pei-Yong Shi, a researcher at the University of Texas Medical Branch at Galveston, is trying to get permission from the National Institute of Health to conduct a study on resistance to antiviral drugs.
The brouhaha over the BU research started after a team led by Mohsan Saeed, a virologist at BU's School of Medicine, posted a preprint on bioRxiv. A new strain of SARS-CoV-2 was created by putting the spikeprotein from the Omicron BA.1 lineage into the back of a viral strain isolated in the early days of the epidemic.
This strain caused severe disease in mice that were designed to be susceptible to the disease. Eight of the ten mice exposed to the strain died or had to be killed due to weight loss and other consequences of the infections. The unaltered ancestral SARS-CoV-2 strain killed all the mice in the study.
David Ho is a researcher at Columbia University in New York City. Concerns have been raised that the current version of Omicron is more harmful than the previous version.
The work was done in a biocontainment facility that was deemed safe by the Boston city public-health board. It's not clear if the BU study has run afoul of any rules. Under current guidelines, any research funded by the US Department of Health and Human Services that can bereasonably anticipated to make a potential pandemic pathogen more transmissible should be reviewed.
The National Institute of Allergy and Infectious Diseases was acknowledged in the preprint. BU said in a statement this week that the experiments were carried out with funds from Boston University. The support from NIAID was used to help develop the tools and platforms that were used in the research.
Experiments on the spectrum of coronaviruses are relatively low-risk. The hybrid virus is derived from two strains that have not been able to compete with each other. The ancestral strain of the virus that laboratories around the world continue to work with is less harmful than the researchers' creation.
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This type of work needs to be thoroughly reviewed and assessed. This is not in the category of the most alarming types of coronaviruses studies. It seems very unlikely that this virus could cause a large-scale outbreak.
The National Institute of Health said in a statement that it did not fund the specific experiments reported in the preprint, and that it is looking into whether the research still fell under its oversight.
According to Shi, regular communication between researchers, funders and local bio safety committees can prevent problems and misunderstandings of the BU study. His team created strains to study the ability to evade vaccines that are made with weakened forms of the disease.
NIAID supported the researchers through an existing grant when they wanted to conduct experiments nearly identical to the ones described by the team.
The researchers were given the go-ahead by NIAID and the institutional biosafety committee, but only if changes were made to the strain that would improve its ability to replicate in cells and cause less harm to animals. His obligations are clear, according to him.
One of the world leaders in studying the effects of the H1N1 swine flu was Ho's lab. It wasn't always clear what research was subject to review and he was often checking in with officials. NIAID officials got in touch to confirm that the experiments that his team reported did not fall under its oversight.
The team was growing the virus in the presence of drugs to study its ability to evolve resistance. A sublineage called BQ.1 that is likely to drive an infections wave later this year was identified by the studies.
Ho decided not to publish the findings because he was concerned about how NIAID would view them. The agency did not fund those experiments. There is a lot of valuable information that could have been shared.
There has been a years-long effort to revise the US government's funding guidelines for research involving enhancedPPPs The current policy of the US National Science Advisory Board for Biosecurity was asked to be reexamined by theNIH in February. The final report from the NSABB is expected to be released later this year or early next. There is a recommendation to expand the pathogens that could be covered by the policy.
The draft recommendations do not address the fundamental concerns raised in the BU study according to the Harvard T.H. Chan School of Public Health epidemiologist. The final policy should cover any ePPP research done at any US institution, not just research funded by HHS, and should allow for the additional review step to occur if potential for an ePPP to be created becomes apparent, even after the project is funded.
Researchers hope that the update will give them a better idea of how the agency conducts its extra review. As Shi and his team develop COVID-19 antivirals, he would like to study how easily the virus can evolve to evade drugs and whether existing drugs can be used to foil new ones. He doesn't know what experiments he can and can't do.
In some cases, discussions seem to be driven by publicity surrounding experiments such as the BU study, instead of considering the risks and benefits. The public's perception of the risk of research into certain pathogens has been highlighted by the latest controversy. The general public is funding all this research. There are good reasons for people to be more transparent.
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