The FDA's VRBPAC is today starting at 8:30 am

But they are NOT going to be voting on the automatic 'Future Framework' yet

A funny thing happened on the way to completely skipping any further clinical trials and just letting it rip without any clean data collection possible ever again. They stopped short (at least for now).

They clearly got spooked by something. What? I’m not sure. Could it be that they started actually looking at the data (dare I hope?). Could it be that, despite the pretty obvious fake ‘lottery’ of their last meetings, that they do read the submitted commentary and found their souls (or learned caution)? Or is it something else? Something more soulless with technical difficulties on the rollout?

Whatever it is, it looks like we have a reprieve for now.

To review — back on April 6th, VRBPAC met and during that meeting they discussed (without voting) setting up the ‘Future Framework’ concept, or a way to simply skip any trials and authorizations and simply allow brand new products of the market free and clear of any (pseudo) regulation. They wanted to treat it like the flu shot — an annual (or semi-annual or however-many-annual) ‘updated' shot where they take a best guess (and usually fail spectacularly) all automatically decided so no embarrassing data need ever come to light again.

That presentation in April was something to behold. It had the feel of a done deal.

But I guess not.

How do I know this? Because some of the meeting materials are already up, and most importantly, the voting question (below) is up.

They are not voting on anything other than including some kind of specific omicron component for boosters. Nothing more, nothing less. Today’s meeting will not yet be going so far as to cover future variants.

The wording of the voting questions is so critical. There were quite a few discussions in earlier meetings where some of the committee members actually complained about the wording because it eliminated nuance, but the answer from the chair was that they are only voting on that specific question, nothing else matters.

Now, that doesn’t mean we’re completely out of the woods, because there will be presentations and a significant amount of discussion. It is important to note that the discussion questions themselves are quite illuminating to their thought processes right now, and I am highly curious how they’re going to do their little dance around question 3 in light of how incredibly bad the 6mo-4 year-old data was that was presented 2 weeks ago. I foresee some entertaining juxtaposing videos in my future, because this is going to be some impressive mental acrobatics.

For those of you who like to follow along and watch for yourselves, the meeting materials and live video link are available here.

I will be tempting fate again and live commenting at my (4th!) iteration of my Facebook group, Understanding Ohio COVID-19 Data 3.0 — please join the group again if you haven’t already done so, and let’s watch them pretzel themselves.

(For those of you who have not studied Pig Latin religiously, ‘Athrynkay Uwighay’ is my alter ego since my normal account has been banned from groups for a month, again.)