Weighing in on Gain-of-Function Research

By Sharon Washio

Viruses are the ultimate parasites—they use the host’s cell processes to carry out their infectious cycles, from replication to dissemination. As barriers between species are crossed and favorable mutations are aptly selected, viruses evolve to propagate among the population, at times, leading to epidemics or pandemics like the Ebola epidemic or the 1918 Spanish Flu. When a virus adversely affects society, one of the main questions researchers try to answer is what makes the virus so potent. This is usually done by comparing mutant versions of the virus with reduced virulence, or potency, to the original, then assessing for the specific mutations that hinders the virus life cycle.

However, researchers are now looking into elucidating mechanisms of the virus by creating a virus with increased potency, rather than using the conventional attenuated method. This is called gain-of-function research. Controversy surrounding this includes method of keeping the research secure in terms of accessibility, and fears pertaining to accidental release of the virus.

On December 19, 2017, the National Institutes of Health released a notice stating that funding will be resumed for gain-of-function research, after withholding its support since 2014. Gain-of-function research will now be allowed and funded if it follows the “HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens” (HHS P3CO Framework). This framework will help determine if a certain gain-of-function experiment should be allowed. It addresses areas including independent expert review and pathogen requirements (since it has the potential of causing a future pandemic), and rules such as: there must be no alternative procedure to answer the research objective, there must be extensive protocol for possible accidents, the research must be done in a facility that has the necessary security and safety equipment, and must be conducted with no malicious intent.

Benefits of gain-of-function research have been discussed and published by the National Academies Press. A main benefit is that more information will be provided to predict pandemic risks of known viruses, as well as predicting emergence. This provides a head-start in the case of an outbreak, where people will be more well-equipped to develop a vaccine or provide preventive measures. Another benefit stems from economic concerns, in that viable vaccines undergo an extremely tedious and costly process to achieve safety and efficacy, and different vaccine strains should be prioritized to be used to make vaccines.

Gain-of-function research is the epitome of cautious foresight and preparation that describe the public health field. Given the rapidly mutating and evolving nature of viruses, there is always the possibility of a strain that will inflict mortality among millions of people. Researchers are well aware of the risks these pathogens hold, and focus should be placed on perfecting accident protocols and enhancing the security of facilities, as well as protection of the researchers themselves. Through the lens of realism, gain-of-function research should be regarded with watchful optimism.

More thorough analysis pertaining to the risks and benefits of performing gain-of-function research on different viruses can be found in this report published by Gryphon Scientific.

The views and opinions expressed in this article are mine alone and do not represent the views of the Princeton Public Health Review.


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