After the unintentional exposure of live Bacillus anthracis (anthrax) to workers at the CDC and accidental cross-contamination of a culture of non-pathogenic avian influenza with the highly pathogenic H5N1 strain of influenza at a USDA lab in 2014, research on manipulation of pathogens has been under increased scrutiny. Gain-of-function (GOF) research on pathogens is intended to enhance the pathogenicity or increase transmissibility in order to better predict future pandemics and potentially design vaccines in advance of outbreaks. The U.S. government called for a “pause” on any GOF studies involving influenza, SARS, and MERS viruses in October 2014 following these biosafety violations.

A recent risk analysis of GOF research by Marc Lipsitch and Thomas V. Inglesby used a simulation model of an accidental infection of a laboratory worker with a transmissible influenza virus strain; the simulation model estimated a 10–20% risk that such an infection would escape control and spread widely. The researchers estimated that a single laboratory-year of experimentation on virulent, transmissible influenza virus could lead to an additional 2,000 deaths per year – with the potential for as many as 1.4 million additional fatalities per laboratory-year.

Although GOF research supporters state that the benefits outweigh the risks, opponents like Lipsitch emphasize that there are methods for obtaining those same benefits without these increased risks.

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