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New government rules aim to limit risky virological work

New government rules

Imagine that you are a virologist. You are researching monkeypox, and in an effort to better understand which genes make monkeypox lethal, you take genetic components from one of the monkeypox clades that is more lethal and components from a clade that is less lethal but more transferable. (Because you’re a virologist, you know that a clade is a group of organisms that share specific genetic traits.) You combine them to create a new variant of monkeypox with traits from both the lethal version and the contagious one.

Would this work be covered by US guidelines that require heightened security screening for research that could potentially trigger a deadly pandemic?

According to the current guidelines, this is actually not clear. When researchers at the National Institute of Allergy and Infectious Diseases (NIAID) planned such an experiment, a safety committee ruled they were exempt from review. Monkeypox, after all, is not a “potential pandemic pathogen”, one of the exceptionally risky viruses like influenzas and coronaviruses that the guidelines are aimed at.

And while current guidelines also target work on any virus “enhanced” to be more dangerous, NIAID researchers said they did not expect their new hybrid virus to be deadlier than the deadliest of all. starting strains or more contagious than the most contagious of the starting strains.

This may seem like a bizarre way to decide when heightened safety standards are appropriate for virology research. Admittedly, what interests us is not how viruses are classified, but the extent of the damage that would be caused if the end result were to infect people – as happens with disturbing frequency in laboratory accidents across the world.

Fortunately, a new set of proposed guidelines released last week by the National Scientific Advisory Board for Biosafety (NSABB) would change the way we assess research with the potential to cause a pandemic – hoping to make the process more transparent and reasonable while ensuring public safety. of a potential disaster.

This represents “a number of important advances,” Tom Inglesby, director of the Johns Hopkins Center for Health Security, told me.

Defining pandemic potential by results

Here’s a simple way to define whether the research should be subject to additional safety oversight: Is the end result of the work, or any intermediate result, a virus that could trigger a pandemic? If so, additional safety monitoring is probably appropriate!

The NSABB Board found significant gaps in the current standards. “Current definitions of a PPP [potential pandemic pathogen] and enhanced PPPs (PPPs) are too narrow,” they write in the report. “The focus on pathogens that are both ‘highly’ transmissible and probably ‘highly’ virulent could lead to neglect of some research involving the creation, transfer, or use of pathogens with increased potential to cause a pandemic.”

Let’s say a pathogen is incredibly contagious but only slightly deadly. It may not sound so bad, but you just described Covid-19, which has killed tens of millions of people around the world. As we should all know by now, a pathogen as deadly as SARS-CoV-2 is always catastrophic if it is contagious enough to go global.

Also, by current standards, if the method by which the virus is made more contagious or more deadly involves swapping components of the virus with a different variant that is more contagious or more deadly, that also does not count as an “enhanced” virus. But of course, in the sense that public policy should be concerned with the chances of millions of people dying, the changes are obviously an improvement!

“What matters is not the starting pathogen but the resulting pathogen,” Inglesby said. “If that results in a new pathogen or a new variant that has a new high transmissibility or a new high lethality, then that is subject to surveillance.”

The NSABB Board has proposed these revised guidelines:

“Amend USG P3CO policy to clarify that federal departmental level review is required for research that can reasonably be expected to improve the transmissibility and/or virulence of any pathogen (i.e. PPP and non-PPP) such that the resulting pathogen is reasonably expected to exhibit the following characteristics that meet the definition of a PPP:

  • Probably moderately or highly transmissible and likely to spread widely and uncontrollably in human populations; and or
  • Probably moderately or highly virulent and likely to cause significant morbidity and/or mortality in humans

Pandemics can be nightmarish. Our policy must reflect this.

Biologists have made tremendous progress in their ability to understand and manipulate DNA and RNA over the past few decades. It has been extremely beneficial to mankind, and no one wants to stop the research that leads to these advances.

But it is not uncommon for pathogens to escape from the laboratory. That’s not the stuff of conspiracy theories – as a recent series of investigations in Intercept revealed, lab accidents happen far more often than we think and rarely lead to serious policy changes. And given the magnitude of the damage a pandemic can cause, that means research into creating new pathogens with pandemic potential must be subject to a level of scrutiny that the government has, until now, had. difficult to clarify.

Some of the confusion stems from the scaling challenge around catastrophic risk. Most workplace safety rules are supposed to protect the lives of employees – possibly dozens of people. Technical reliability rules for bridges and skyscrapers aim to protect the lives of hundreds, if not thousands, of people.

If something goes wrong – if these rules aren’t strict enough or aren’t enforced – it’s a very bad day for these people, but not beyond that. Pandemic prevention rules, however, are needed to protect the lives of millions. A mistake in a lab that triggers something like Covid – or something worse – not only endangers those who work in that lab but potentially all of us. The degree of caution required for these astronomical stakes is simply different from anything else.

Above all this is the question of the true origins of the Covid-19 pandemic. While there’s no hard evidence that the SARS-CoV-2 virus started life in a lab — and there probably never will be — the very fact that it’s hard to Know precisely what may have happened at the Wuhan Institute of Virology should make us think. . The number of Biolabs dedicated to working on the world’s most virulent pathogens is growing, as is our ability to play with the genetics of a virus. It’s a dangerous combination.

The new guidelines are not perfect. For one thing, they’re still focused on the United States, and any effective effort to prevent man-made pandemics and ensure risky research takes place safely must be global — just as pandemics will be. such works could trigger. But it’s a big step forward in making the rules more consistent, more reasonable, and more focused on where the stakes are highest.

A version of this story originally appeared in the Future Perfect newsletter. Sign up here to subscribe!

Clarification, 1 p.m. ET: This story has been updated to clarify that “virulent” in this context refers to how deadly a virus is, and “contagious” refers to how easy it is transmitted.

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