Details for the FDA meeting tomorrow (12/10/20)…
Tomorrow an external committee, made up of scientists with no conflicts of interest (if you're skeptical, here is the list of members https://www.fda.gov/media/144232/download), will meet regarding the Pfizer vaccine. They will discuss COVID19 epidemiology, the vaccine’s safety data, the vaccine’s effectiveness data, hear from Pfizer, and hear from the FDA. At the end, they will vote as to whether the vaccine should be approved for emergency use in the United States.
As a member of the public, you can attend. The event will live stream on the FDA website, YouTube, and Twitter (use Chrome). Here are the links:
FDA website: https://www.fda.gov/.../vaccines-and-related-biological...
YouTube: https://youtu.be/owveMJBTc2I
Twitter: https://twitter.com/US_FDA
If you want to log on at a certain time, here is the agenda. All times are in EST.
9AM: Opening remarks
930AM: FDA Presentation on Emergency Use Authorization
10AM: Update on Epidemiology
1030AM: Vaccine Safety and Effectiveness Monitoring.
1050AM: Considerations for placebo-controlled trial design if vaccine becomes available. (They will basically discuss whether those that got the placebo will be unblinded to get the real vaccine)
1PM: Pfizer Presentation
2PM: FDA Presentation
3:10PM: Discuss and VOTE
As a member of the public, you can also submit comments and questions to the FDA until 11:59pm CST tonight. If you submit tonight (i.e. last minute), the voting members won’t have your comments, but the FDA will still take into consideration your points. You can submit them electronically here: https://www.regulations.gov. The docket number is FDA-2020-N-1898.
Look forward to “seeing” you there!
Love, YLE