Dr. Fauci Speech at NIH COVID-19 Summit Transcript November 6

Speaker 1: (00:00) Good morning, Dr. Fauci. Dr. Fauci: (00:02) Greetings to you all. It's a real pleasure to be with you today albeit virtually to introduce this NIH virtual SARS-CoV-2 Antiviral Therapeutic Summit. First with regards to my opening remarks I'd like to just spend a moment to point out the seriousness of the current situation. This slide shows both the daily cases in red and the current hospitalizations in blue. As you can see it's been somewhat of a roller coaster effect which we had a very impressive peaking early on in the spring dominated by the New York Metropolitan Area, which then came back down but never got down to a low baseline. Dr. Fauci: (00:46) The second peak is when we tried to reopen the country and reopen the economy. And this led as you can see here to a surge in cases, bringing up the daily number of cases to approximating 70,000. Went down a bit and then as the cooler weather came in and college students came back and people did more things indoor we had another surge both in cases and hospitalizations which has now approached 100,000 per day. Dr. Fauci: (01:21) Deaths as you see came down after the initial Northeastern city peak but have remained stable around 700 to 1000 per day, an unacceptably high level so the challenge we have is truly extraordinary. And in that regard, this is the NIAID strategic plan for COVID-19 research that we put out in April of this year. There were four major components of it. We're going to discuss in today's workshop the characterization and testing of therapeutics of which we have already and there will be more coming put in several hundreds of millions of dollars in cumulative NIAID spending. Dr. Fauci: (02:05) So very briefly as an introduction let's take a look at this. The fundamental windows of opportunity for the therapeutic management of COVID-19 are schematically diagrammed on this slide. As you know early on we have therapeutics that are really for prophylaxis pre-exposure to the SARS coronavirus, and then the presymptomatic or very minimal symptomatic antiviral window as we call it where you try to attack the virus very early on in the course. This slides over into when you get some degree of symptoms particularly respiratory symptoms and the therapeutic efficacy of antiviral effects can still predominate. But as you then merge into the more symptomatic period of infection you then switch over from a predominantly antiviral effect to more of an immunomodulator where you block the symptoms and the signs of hyperinflammation sometimes referred to as salvage therapy. Dr. Fauci: (03:10) In that regard what we have right now are two drugs that have undergone randomized placebo-controlled trials and have shown to have benefit both in diminishing the time to recovery with Remdesivir and diminishing the 28-day mortality with dexamethazone. And then we have a number of other investigational therapies that are in various levels of clinical trial. The antivirals that I mentioned in a moment we need to do much better in that as well as blood-derived products, convalescent plasma, hyperimmune globulin. And then a lot of emphasis is being put again on monoclonal antibodies which are in various levels of clinical trial. Immunomodulators I've already mentioned as well as adjunct therapies including anticoagulants. Dr. Fauci: (03:56) The NIAID support of this therapeutic approach is shown on this slide with grants and contract supplements, preclinical services that will enable our investigators in the extramural community to test potential therapeutics both in vitro and in vivo. Our clinical trials via the accelerated COVID-19 therapeutics interventions in vaccines well known as the ACTIV program and a number of public private partnerships. Dr. Fauci: (04:27) One of the things I want to point out is that a report from the National Academy of Sciences in April, 2017, emphasize that the core principles of science and ethics in conducting clinical research during an epidemic does not change and randomized placebo-controlled trials or randomized controlled trials with some form of intervention serving as the control arm is an ethical and appropriate way and the most efficient and reliable way to determine safety and efficacy. And in fact, this was shown very, very clearly during the Ebola outbreak in Africa which we had recent experience with. And this is the PALM Consortia study that was done in collaboration with our African colleagues, JJ Muyembe, and on our side, Cliff Lane, was the randomized control trial of Ebola virus therapeutics which two antibodies monoclonal antibody 114 and the Regeneron antibody was shown to reduce mortality in that group. Dr. Fauci: (05:31) We refer often to the AIDS research models and their implications for other infectious diseases very briefly. Some of you remember years ago in which we looked at their replication cycle for the HIV virus and all of the vulnerable points of intervention including reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors, et cetera, all of which led to an extraordinary success story in a number of FDA-approved antiretroviral drugs, which now very readily and consistently bring down the level of virus to below detectable levels. Remember that's a chronic viral infection, certainly different from the acute situation we're facing with COVID-19. Dr. Fauci: (06:18) But nonetheless, the lessons we learned from HIV was the commitment of substantial financial and human resources which we are now replicating with COVID-19, bringing in the best and the brightest investigators domestically and internationally, engaging with the community, fostering cross-sector collaboration such as with industry which we are doing, global organizations and philanthropies and garnering the support which we have of our leaders and policymakers. This is an analogous slide of the replication cycle of SARS-CoV-2, very much comparable to what I showed you a couple of slides ago with HIV. And again each of these provide vulnerable targets in the replication cycle. Dr. Fauci: (07:07) Finally, on this last slide we know what our goal is. I hope and I believe that we will achieve it, it's to really garner and foster interest and activity in the therapeutics through this summit with a variety of approaches that you'll be hearing about shortly. The overview of virus and therapeutic approaches, viral replication machinery, the status of vaccines and neutralizing antibody, proteases both viral and host, emerging targets, preclinical tools, lessons that we learned from other viruses, and then we'll have a summary of discussions and what perspectives of the challenges ahead. Thank you very much and I wish you a very successful meeting. Speaker 1: (07:53) Thank you, Dr. Fauci.