Erik Stemmy

I'll say generally that NIAID has an extensive review process for P3CO (and formerly for GoF) and that all of this work was formally evaluated by the respective committees and determined not to be gain-of-function, nor subject to P3CO oversight.

Reading Room Production, p.28 · original PDF · in context

There may be some misunderstanding of gain-of-function experiments, so hopefully this will clarify some things or at least provide a framework for our discussion next week.

Reading Room Production, p.53 · original PDF · in context

On page 192 of SF 424 AI110964-06 (received date 11/05/2018) under P3CO Research, it indicates they are conducting gain of function of SARSr-CoV.

Reading Room Production, p.53 · original PDF · in context

The funding pause on gain-of-function (GoF) experiments was in place from 2014-2017, and explicitly involved work reasonably anticipated to enhance the transmissibility or pathogenicity of influenza, MERS-CoV, or SARS-CoV.

Reading Room Production, p.53 · original PDF · in context

The replacement policy, Potential Pandemic Pathogen Care and Oversight (P3CO), requires additional review and oversight of experiments that are anticipated to increase a potential pandemic pathogen's transmissibility or pathogenicity in humans.

Reading Room Production, p.53 · original PDF · in context

From a review of their experimental details, it looks as if they were generating recombinant DNA of the viruses using WIV1 as the backbone but I could not determine if they were for investigators in this field are to create cDNA I know UNC-Chapel Hill you know where this was he iuldn't jJicates Then ent at mice these molecular clones are used to grow id UNC-CH performed studies with molecular e "mation but tion describes animal work at work.

Reading Room Production, p.53 · original PDF · in context

I could not determine exactly where they were conducting these gain of function experiments.

Reading Room Production, p.53 · original PDF · in context

This award did not support work to manipulate CoV genomes or create chimeric viruses at Wuhan Institute of Virology; such work was performed at UNC-CH.

Reading Room Production, p.53 · original PDF · in context

I believe UNC mean to say that the work "... does not include human research subjects." SF 424 AI110964-01 (received date 06/05/2013) In this SF 424 Aim 3 seems indicative of gain of function experimentation (C3a and C3b) although it does not use that exact term.

Reading Room Production, p.53 · original PDF · in context

The receipt date of this application was June of 2013, and the term "gain-of-function" was not widely used before the USG funding pause was announced in 2014.

Reading Room Production, p.53 · original PDF · in context

On page 119 of AI110964-01 under "C3d) Humanized mouse in vivo infection experiments" it states that humanized mouse in vivo experiments in humanized mice was occurring at the Wuhan Institute of Virology.

Reading Room Production, p.53 · original PDF · in context

I did not see the location where these gain of function experiments were being done but if the injections were occurring at WIV then was the recombinant DNA also generated at WIV?

Reading Room Production, p.53 · original PDF · in context

Further, the USG P3CO Policy Guidance states that "Wild-type pathogens that are circulating in or have been recovered from nature are not enhanced PPPs, regardless of their pandemic potential." RPPR (AI110964-05) Finally, in the RPPR (6/1/2017-5/31/2018) on page 28 under "In Vivo Infection of Human ACE2 Expressing Mice with SARSr-Cov S Protein variants", it appears to be showing the results from their gain of function experiments as described in the SF 424.

Reading Room Production, p.53 · original PDF · in context

The figure you reference (Fig 35) shows weight loss and lung viral titers of chimeric viruses with bat CoV (wild type WIV-1, SHC014, WIV16, and 4231) spike proteins expressed on the WIV-1 backbone.

Reading Room Production, p.53 · original PDF · in context