Live - June 7th, 2022 - FDA Advisory Committee Meeting on Novavax COVID Vaccine (Part 1)

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

If you like this content and want more, I am doing a special lifetime membership offer. Click here:
https://www.drbeen.com/yt-special/

Link to the FDA channel: https://www.youtube.com/watch?v=DfdMsAqkneE

Want to support this work?:
Buy me a coffee :-) https://www.buymeacoffee.com/DrMobeenSyed
Become my patron: https://www.patreon.com/mobeensyed?fan_landing=true
PayPal: https://paypal.me/mobeensyed?locale.x=en_US

My substack: https://mobeensyedmd.substack.com/

#drbeen #koolbeens #COVID

Disclaimer:
This video is not intended to provide assessment, diagnosis, treatment, or medical advice; it also does not constitute provision of healthcare services. The content provided in this video is for informational and educational purposes only.
Please consult with a physician or healthcare professional regarding any medical or mental health related diagnosis or treatment. No information in this video should ever be considered as a substitute for advice from a healthcare professional.

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