2018 Is regulation preventing the development of therapeutics that may prevent future coronavirus pandemics_.pdf

Editorial For reprint orders please contact reprints Is regulation preventing the development of therapeutics that may prevent future coronavirus pandemics Timothy P Sheahan 1 Accepted for publication 27 November 2017 Published online 21 February 2018 In the last century hundreds of new emerging infectious diseases EIDs have arisen in human populations most of which originate from wild animals as zoonoses 1 The recent surge of zoonotic EIDs in human populations is driven by a constellation of socioeconomic factors including human population growth eroding public health infrastructures changes in land use and agriculture and ease of global travel HIV Ebola virus avian infl uenza H5N1 H7N9 etc severe acute respiratory syndrome coronavirus SARS CoV and Middle East respiratory syndrome coronavirus MERS CoV are but a few recent examples of highly virulent zoonotic viral EIDs that have catastrophically affected global economies and public health 2 Geopolitical fl ux since the 1990s and the potential for weaponizing EIDs provoked the creation of myriad policies aimed at protecting the USA from bioterrorist threats and the accidental release of potential pandemic pathogens from laboratories Are these policies effective Are they impacting countermeasure development for current and future EIDs How are they shaping the direction of individual research programs the recruitment of new investigators and the stability of impacted fi elds Below we discuss our experiences in developing therapeutics against SARS MERS and zoonotic CoV in an ever changing regulatory environment Gain of function GOF research is critical for microbiological research in determining causal relationships betweenamutationanditsphenotype In2012 twostudiesdescribingGOFmutationsfacilitatingthetransmission of highly pathogenic avian infl uenza in ferrets set off a fi restorm of debate ultimately resulting in a pause of active GOF research and its future funding 3 While infl uenza research was primarily targeted GOF policies were also extended to studies that could enhance the pathogenicity and or transmissibility of SARS and MERS CoV in mammals requiring regulatory approval of each experiment by NIH or its equivalent Since the types of mammals were not specifi ed and the assessment of mutant virus in humans or all the other approximately 5400 mammals was obviously not possible the GOF policies by nature of their vagueness could never be adequately satisfi ed During the pause a risk and benefi t analysis conducted by the National Science Advisory Board for Biosecurity NSABB helped guide the creation of Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight P3CO released in January 2017 4 5 Almost a year later US Department of Health and Human Services HHS lifted the pause and released policy intended to guide funding decisions of new grant applications involving potential pandemic pathogens that have been enhanced for pathogenicity or transmissibility 6 While the policies for new grant applications are now clear and in place the triage process of amendments to currently funded grant applications remains unknown as oftentimes a new recombinant must be made to address an evolving research question For CoV researchers regulatory complexity increased in 2012 when SARS CoV was designated as a select agent by the HHS and the Centers for Disease Control and Prevention CDC 7 The Federal Select Agent Program FSAP requires those working with pathogens or toxins that pose a severe threat to public health to register and meet certain safety and security standards Many of the 66 pathogens and toxins accompanying SARS CoV on the select agent list are infamous including Ebola virus smallpox and anthrax As such the FSAP has many positive FutureVirol 2018 13 3 143 146ISSN 1746 079414310 2217 fvl 2017 0143C 2018 Future Medicine Ltd EditorialSheahan Biennial Review 77 2012 https www gpo gov fdsys pkg FR 2012 10 05 pdf 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