This afternoon, Josh Trantum, Ph.D. and I had a thorough discussion about where things actually stand on approval of a vaccination against the SARS-CoV-2 virus. We covered the three major areas of discussion within the vaccine community including the approval framework, oversight of trials and post-administration events as well as manufacturing and administration plans. Finally, we talked about what Dr. Fauci really meant yesterday.
To access the call:
CLICK HERE for event replays (includes video/audio and materials link)
0-3:09 - Introductions
3:09 - 9:09 - FDA Vaccine and Biological Products Advisory Committee overview and scope Oct. 22 meeting
9:10 - 18:27 - Vaccine candidates, development process and platform technologies
18:28 - 25.32 - Background on Emergency Use Authorization and concerns of VBPAC and issue of unblinding studies
25:32 - 26:44 - Status of MRNA and BioNTech's trials and availability of interim analysis
26:44 - 31:04 - Primary endpoint of symptomatic disease versus others discussed
31:04 - 35:21 - Efficacy requirements and special populations
35:22- 37:33 - Independent Safety Monitoring Board and ongoing monitoring
37:33 - 41:53 - Two-month post-vaccination monitoring
41:54 - 43:45 - What Dr. Fauci said
43:45 - 52:43 - What is "availability," target populations and challenges of distribution and administration
51:43-1:04 - Q & A
About Josh Trantum: Josh has extensive experience sourcing, licensing and developing pre-clinical biopharmaceutical assets in a broad range of therapeutic categories and disease areas. He also holds an adjunct appointment as an assistant professor in Biomedical Engineering at the Vanderbilt University School of Engineering. You will want to tune in because Josh is great at translating scientific discovery into investment opportunity, something he does each day at his life sciences fund, Curex Capital.