Boston University denies report lab created dangerous strain of COVID 03:02

The National Institutes of Health is now reviewing whether experiments done at Boston University should have prompted a federal review, the agency says, after scientists at the school tested strains they created of the COVID-19 virus by combining ancestral and Omicron variants. Federal health authorities say they are looking into whether scientists should have sought their permission before undertaking research that could lead to a “gain of function” in the virus by acquiring new or improved abilities, which may be “inherently dangerous”. And locally, a spokesperson for the Boston Public Health Commission says it is now reviewing the application materials from the study scientists “to confirm that the research was conducted according to protocols and was properly supervised.” The committee approved a proposed research protocol submitted by the scientists in March 2020, the spokesperson said. But Boston University says its research followed “all required regulatory obligations and protocols” to safely experiment with the viruses. “Before anything is done in the [National Emerging Infectious Diseases Laboratories]it goes through multiple levels of careful safety review, and that’s done through committees that are part of Boston University and also committees that are outside, independent of BU,” Robert Davey, a professor at Boston University’s National Laboratory for Emerging Infectious Diseases. he said in a statement. The scientists were studying the role that the Omicron variant’s highly mutated spike protein might play in its generally milder severity compared to previous waves. The mice were exposed to “chimeric recombinant” versions created by the scientists, which carried the spike protein of the Omicron variant combined with the “backbone” of the original strain. Similar types of recombinant variants have evolved in nature. Their findings were released Friday as a preprint that has yet to be peer-reviewed. The NIH audit was first reported by Stat News. Although NIH money was not immediately sought for the experiments, the agency is investigating whether it may still be subject to their grant policy. The experiments also may have needed approval first from federal government rules governing experiments that could lead to a “gain of function” in the virus, the NIH said. This type of research is supposed to be reviewed by a panel of experts convened by the federal government before it can be funded. But Boston University says it had “no obligation to disclose this research” to the NIH. While funding from the NIH’s National Institute of Allergy and Infectious Diseases was acknowledged by the scientists in their work, Boston University said the grants were only for “tools and platforms” used by the scientists. “NIAID funding is acknowledged because it was used to help develop the tools and platforms used in this research. They did not directly fund this research. NIH funding is also acknowledged for a joint instrument grant that helped support the pathology studies ,” Rachel Lapal Cavallario, a university spokesman, said in a statement. News of the NIH research follows coverage of the Boston University research first in the Daily Mail. The university had accused the tabloid of sensationalizing their research, with “false and inaccurate” reports that took their findings out of context. For example, those early reports of the findings noted that 80% of infected mice died after the scientists infected the animals with the recombinant strain, while none died after exposure to the Omicron variant. The university points out that the original variant led to 100% of the mice dying, meaning their recombinant virus was effectively made “less dangerous”. If there were signs that the viruses they created for their experiments were “getting functional,” the scientists would have stopped “immediately” and reported their research, Lapal Cavallario said. The research was also conducted in the university’s ‘BSL-3’ laboratory. This is the second highest level of precautions scientists can take when studying viruses, other than those taken to study the most dangerous pathogens “for which no vaccine or treatment is available.” “We take our safety and security very seriously in how we handle pathogens, and the virus doesn’t leave the lab it’s being studied in,” said Ronald Corley, director of Boston University’s NEIDL. The study’s lead author, Mohsan Saeed, and other experts cited other research that has conducted similar kinds of experiments without controversy. A study authored by Food and Drug Administration researchers over the summer also created “chimeric viruses” with Omicron and the progenitor strains for testing in mice. “In this case, we are interested in understanding the viral genes or factors or mutations that weaken SARS-CoV-2 so that we can use the knowledge to design live-attenuated virus vaccines,” said the FDA spokeswoman, Abby Capobianco. The FDA’s internal research review boards approved the work, Capobianco said. The work was deemed not to be so-called “P3CO” research, which would have prompted a review before experiments that may “create, transfer or use” enhanced pandemic potential pathogens (ePPP). The Boston University prerelease comes amid scrutiny of the federal government’s policies governing ePPP research, which are in the midst of a review by an NIH task force. “It is troubling that this research – like the Wuhan research that may have caused the pandemic – was not recognized by the funding agency as potential ePPP research,” Rutgers University professor Richard Ebright tweeted. Ebright and others also disputed the university’s claim that the research was not an “operating profit” experiment. “First, these are clearly gain-of-function experiments. As many have noted, this is a very broad term that includes many harmless and some potentially dangerous experiments,” Marc Lipsitch, an epidemiologist at Harvard University and a key official at the Centers for Disease Control and Prevention. Control and Prevention’s predictive arm, it said on Twitter on Wednesday. More Alexander Tin CBS News reporter covering public health and the pandemic.