1 year ago

214

Live - June 7th, 2022 - FDA Advisory Committee Meeting on Novavax COVID Vaccine

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0:00 Dr. Been Intro
0:45 FDA Intro of Topic (10 min) Goutam Sen, FDA
1:00 Available vaccines
1:08 Dr. Kim - no observed worsening of autoimmune conditions
1:40 Overview of Agenda
3:00 Voting Question for Committee
3:16:00 Booster dose
3:17:20 Crossover analysis on efficacy?
3:19:00 Eukaryote Protein expression systems
4:57:20 Dr. Offit on myocarditis
5:00 Committee preliminary questions
5:05 Alternative vaccine for unmet needs
5:09:00 Sterlizing immunity & transmission?
5:12:05 Vaccine differences in diff countries
5:14:10 Sapponin interactions
7:10 Manufacturing concerns
8:30 Dose schedule
10:00 Durability and breadth of immune response
11:25 Current Epidemiology of COVID-19 and vaccination rates in US (20 min). Heather Scobie, CDC
32:00 "Fully vaccinated" with primary series vs "Up-to-date" with current recommendations
35:40 Monoclonal antibodies & other therapeutics effectiveness with variants
40:18 Overview of COVID-19 vaccine associated myocarditis (15 min). Tom Shimabukuro, CDC
59:00 Questions
1:09:30 Sponsor Presentation
1:09:30 Overview by Filip Dubovsky, VP & Chief Medical Officer
1:18:30 Immunogenicity & Efficacy by Raburn Mallory, SVP Clinical Dev.
1:30:30 Safety Data by Denny Kim, Chief Safety Officer
1:50:20 Clinical Perspective by Gregory Poland (Mayo Vaccine Research, consultant)
2:01:00 Conclusion
2:02:00 Q&A
2:03:00 Lower VE for Hispanics? Safety data on other saponin adjuvants?
2:14:00 (Break) Dr. Been comments
2:29:30 FDA Presentation: FDA Review of Effectiveness and Safety of Novavax by Lucia Lee, M.D. , FDA
3:20:30 (Lunch) Dr. Been Responses
4:00:05 Open Public Hearing
4:45:00 Additional Q&A re. Sponsor & FDA presentations
5:52:00 Committee Discussion
6:11:00 Concern for additional investigation
6:14:00 Standard going forward on protection against variants
6:20:00 Committee Voting
6:27:27 Committee Vote Explanations