BiosecurityU.S. ends 3-year ban on research involving enhanced-lethality viruses
The U.S. National Institutes of Health (NIH) yesterday announced it was ending its three-year moratorium on funding of gain-of-function research, that is, research which aims to make extremely dangerous viruses even more dangerous in order to find a vaccine or cure for them. The U.S. government instituted the ban in 2014, against the backdrop of rising worries that these “gain-of-function” studies would allow scientists to increase the ability of the infectious disease to spread by enhancing its pathogenicity, or its ability to cause disease. Scientists who supported continuing research involving enhancing the transmissibility of infectious disease were not helped by a series of safety mishaps at federal research facilities.
The U.S. National Institutes of Health (NIH) yesterday announced it was ending its three-year moratorium on funding of gain-of-function research, that is, research which aims to make extremely dangerous viruses even more dangerous in order to find a vaccine or cure for them.
There are deep divisions in the scientific community about this kind of research, which all agree is extremely risky.
On Tuesday, the agency unveiled new guidelines which would govern the research of scientists who seek NIH support in studying pandemic-causing pathogens. Science reports that now, in NIH-approved labs, scientists may increase the strength of viruses like severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and influenzas to understand how they evolve and spread, and how to combat them.
The term “gain-of-function” is the technical term for increasing the strength and lethality of viruses.
NIH Director Francis Collins said on Monday that the decision will “help to facilitate the safe, secure, and responsible conduct of this type of research.”
The World Health Organization (WHO) notes that the pathogens affected by the three-years ban – among them H5N1 influenza, SARS, and MERS — cause severe disease and have a high mortality rate. The mortality rate for human cases of H5N1 is 60 percent, the mortality rate for MERS is 35 percent, and the mortality rate for SARS ranges from 1 to 50 percent, increasing with the age of the infected person.
Nature notes that the U.S. government instituted the ban in 2014, against the backdrop of rising worries that these “gain-of-function” studies would allow scientists to increase the ability of the infectious disease to spread by enhancing its pathogenicity, or its ability to cause disease.
Scientists who supported continuing research involving enhancing the transmissibility of infectious disease were not helped by a series of safety mishaps at federal research facilities. In 2014, two labs were forced to close after the facilities accidentally shipped live anthrax and a highly virulent strain of H5N1. In that same year, six vials of live smallpox were found in an FDA lab in Bethesda, Maryland, and 75 CDC employees in Atlanta were thought to be exposed to anthrax (see “Lawmakers demand answers on labs’ handling of deadly pathogens,” HSNW, 7 July 2015; “Pentagon, CDC investigating live anthrax shipping mishap.” HSNW, 8 June 2015; “Following accidents, CDC shuts down anthrax, flu labs,” HSNW, 14 July 2014).
Nature notes that scientists had argued that the ban was too broad, and that its lifting means that the government has now decided the ad experiments are not as serious a threat to the public as previously though. In the new guidelines, the NIH says that research involving potential pandemic pathogens is “essential to protecting global health and security.”
The new rules for studying the pathogens stipulate that gain-of-function experiment may only proceed if there are “no feasible, equally efficacious alternative methods to address the same question in a manner that poses less risk than does the proposed approach.”
