What Was the FDA Expecting from the Vaccines?

The US Food & Drug Administration (FDA) has an internal organization called the Vaccines and Related Biological Products Advisory Committee (VRBPAC). It’s function is described as:

The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility.

FDA

Looking at the Committee’s calendar, it appears to meet every 2-3 weeks. Meetings become available as podcasts. Here is the meeting from October 22 of last year: Vaccines and Related Biological Products Advisory Committee – 10/22/2020. At almost 9 hours it’s much too long to view. So as a tip (from a friend who doesn’t need more grief), go to the 2:33:30 minute mark and you will see slide 15 of the presenter. Here’s the screen grab:

The presenter is describing a “near real-time surveillance system” that they monitor the vaccines with.

The presenter then skips page 16. In fact, it appears as a single frame which is not perceptible at ordinary viewing speed. However, using YouTube settings, set the speed to 0.25x, the slowest possible. If you are prepared and real fast, you can freeze the video on the single frame of page 16. It took me several tries to get it but here it is:

What is interesting is that the FDA was anticipating these serious adverse reactions to the mRNA vaccines a month and a half before they granted Emergency Use Authorization (EUA) for these vaccines to Pfizer on December 11, 2020 and Moderna on December 18, 2020. Well over half of the adverse effects listed cover either the central nervous system (CNS) or the cardiovascular system.

Several questions come to mind:

1. Why was this slide skipped? The presenter presumably had lots of time and surely these detail would be of interest to some committee members, particularly with an approval process coming up.
2. Did they have advance knowledge informing this selection of adverse effects? Those shown affect mainly the cardiovascular and the CNS. We knew at that time that the SARS-CoV-2 virus impacted the hepatic, gastrointestinal and renal systems also but these are not mentioned. This suggests the selection was not informed by knowledge of viral damage but by advanced information about the vaccines.
3. If they have a functioning, almost real-time surveillance system, where are the results? Weekly reports would be a reasonable expectation.
4. Why are no red flags coming out of the FDA? FDA response to the myocarditis and Guillain-Barre syndrome issues seems to have been precipitated from outside the Agency.