Moratorium on Research Intended To Create Novel Potential Pandemic Pathogens

Research on highly pathogenic organisms is crucial for medicine and public health, and we strongly support it. This work creates a foundation of new knowledge that provides critical insights around the world’s most deadly infectious diseases, and it can lay groundwork for the future development of new diagnostics, medicines, and vaccines. Almost all such research can be performed in ways that pose negligible or no risk of epidemic or global spread of a novel pathogen. However, research that aims to create new potential pandemic pathogens (PPP) (1)—novel microbes that combine likely human virulence with likely efficient transmission in humans—is an exception to that rule. While this research represents a tiny portion of the experimental work done in infectious disease research, it poses extraordinary potential risks to the public. Experiments that create the possibility of initiating a pandemic should be subject to a rigorous quantitative risk assessment and a search for safer alternatives before they are approved or performed. Yet a rigorous and transparent risk assessment process for this work has not yet been established. This is why we support the recently announced moratorium on funding new “gain-offunction” (GOF) experiments that enhance mammalian transmissibility or virulence in severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and influenza viruses. This realm of work roughly corresponds with the work we have termed PPP above. Because the term “gain of function” in other contexts can be used to describe techniques of scientific research that have nothing to do with the creation of novel potential pandemic pathogens, we think the term can be too broad and can mislead. Throughout this commentary, we focus on research designed to create PPP strains of influenza virus, the type of research that initially attracted attention, leading to the moratorium and for which the most discussion has already occurred. Other types of gain-of-function research on influenza and studies intended to enhance pathogenicity or transmissibility of MERS and SARS coronaviruses may or may not fit the definition of PPP research and further clarification is needed and ongoing. As we discuss near the end of this article, it will be essential to clarify the different risks and benefits entailed by different types of experiments covered by the funding pause (2). The purpose of this research funding pause is to complete “a robust and broad deliberative process . . . that results in the adoption of a new [U.S. Government] gain-of-function research policy” (3). The moratorium would stop new funding for the following: