US health officials have launched an inquiry into a controversial study by scientists at Boston University who created an artificial form of Covid-19 in a laboratory.
The National Institutes of Health told the Financial Times its officials were investigating whether the study, which was partly funded by the US government, should have gone through extra checks before going ahead.
An early version of findings from the study, in which researchers combined a lab-made version of Covid-19’s original strain with the spike protein from the more transmissible Omicron variant, was published last Friday. Omicron has proved less deadly than the so-called “wild type” of the virus, but has spread far more quickly because it is better able to escape immune protection.
The new artificial strain killed 80 per cent of mice that were exposed to it, making it slightly less pathogenic than the original strain. But the university said it did not test to see whether it spread more quickly than the original strain.
NIH said it had not reviewed the work before it went ahead, even though researchers were using government money.
“NIH is examining the matter to determine whether the research conducted was subject to the NIH grants policy statement or met the criteria for review under the [government’s guidelines for certain experiments with dangerous viruses],” a spokesperson said.
Boston University said it did not have to alert NIH before carrying out the work because government money did not fund the experiments directly, although it was used for tools and techniques to carry them out.
A spokesperson for the university said: “The research was reviewed and approved by the Institutional Biosafety Committee, which consists of scientists as well as local community members. The Boston Public Health Commission [the city’s public health department] also approved the research.”
The person added: “We fulfilled all required regulatory obligations and protocols.”
The university denied its work should count as gain of function research — when scientists try to endow viruses with new abilities — because the lab-made virus killed fewer mice than the original strain killed.
However, the controversy threatens to reignite a debate over this type of research, which some critics say is unnecessarily risky because it poses a risk of accidental infection that could start a pandemic. One unnamed US intelligence agency believes this may be how Covid-19 started, at the Wuhan Institute of Virology in China.
Scientists say they want to carry out such work to investigate how viruses behave, and whether they might pose a future risk to people.
The US government has funded millions of dollars’ worth of gain of function experiments in the past, but now insists that any such projects gain the approval of a separate committee of experts before going ahead.
The government’s scientific advisory board is reviewing the guidelines for such approvals, with many experts warning that the process remains opaque.
The Boston University research was designed to test the mutations in the spike protein of the Omicron strain, which have made it far more transmissible than the original variant of the disease.
The scientists wanted to know whether these mutations also made Omicron less dangerous than the original variant. The work was carried out at biosafety level three, which involves highly controlled airflows and decontamination procedures, but is one level down from the highest security research.
Some experts worry that Boston created a new variant that is nearly as deadly as the original strain and just as transmissible as Omicron. The university said it did not test for transmissibility.
Richard Ebright, professor of chemical biology at Rutgers University, said: “This work constructed a laboratory-generated coronavirus that has the high immune escape properties of Omicron BA.1 and higher lethality than Omicron BA.1.
“It posed an existential risk, and simply served to confirm what other studies had already proved, which is that the lethality of a coronavirus is not just governed by the spike protein. It should not have gone ahead.”
Marc Lipsitch, the director of the government’s Center for Forecasting and Outbreak Analytics and the director of the Center for Communicable Disease Dynamics at Harvard, said: “This is clearly gain of function research. It added the function of evading immunity from the original strain.
“That does not necessarily imply it is a bad idea but to deny this is gain of function is to misunderstand the meaning of the term.”
Alina Chan, a molecular biologist at MIT’s Broad Institute, said: “This highlights the lack of oversight for research of this kind.”
“If there is even a small chance that you might get something surprising from these experiments you would want to have been doing them offshore and at biosafety level four, not a 10-minute drive from downtown Boston,” she added.