Thread by @stormchaseguide

My comments to @US_FDA's VRBPAC committee today:

Dear Committee,

I address you as an admin of a tinnitus adverse event support forum.
1/18

My only conflict is the unlikely copay reimbursement in the two thousand dollar range from CICP if I were to influence recognition, and later file a claim.
2/18

With that, my comments, as a triple, but unfortunately not quadruple dosed individual, are not being made to dissuade vaccination, but have the goal of further improving frequency and outcomes for an unlikely event.
3/18

That is, tinnitus after COVID vaccination, which I developed nearly two years to this day after my dose one. My wife would also later develop tinnitus in mid March of the same year in line with her later phased access and dosing. We still hear our rings, as I speak to you.
4/18

This is an important distinction, this is unlike some other adverse events that resolve, it is also so intrusive we have regularly provided suicide hotline information in our groups.
5/18

This issue though isn't foreign to this committee, a prior member, and Editor-in-Chief of Vaccine, Dr Poland also developed tinnitus, along with his wife. He also experienced variability to his ring after being rechallenged.
6/18

While many others, along with myself, didn't develop tinnitus after Janssen, I thought it would be best to spotlight it in a slide here because it has a particularly strong argument for tinnitus being related, but is still not recognized in the US.
7/18

(Slide)
8/18

Both passive monitoring signals mentioned in the slide were observed for Janssen, but I highlight the second because it has not yet been reported.
9/18

This is because I followed up with Dr Harpaz at Oracle Health Sciences and his group, which includes FDA coauthors, that reported in Drug Safety the effect of masking, in Pharmacovigilance speak, on signals in VAERS data.
10/18

The group didn't consider to examine Janssen, but after requested re-analysis they identified a prior masked signal for tinnitus for this vaccine, the orange curve in the figure. The blue represents a much lower signal score, like what is probably produced by the FDA.
11/18

So I ask, how much longer do, THE vaccinated, not the anti-vax, those that developed tinnitus after Janssen have to wait for the FDA to account for masking within their monitoring?
12/18

Or has this been accounted for, and after all the imbalances, the passive monitoring signals, the foreign government recognition and recognition for a vaccine of the same platform, that this is still actually not enough for recognition here?
13/18

If this is the case, where is the funding for EHR database or inner ear tissue analysis papers, that researchers like Dr Harpaz or Otolaryngologist Dr Stankovic at Stanford want to do?
14/18

I want you to find answers to these questions.
15/18

That's my call of action to you, and this just scratches the surface for the challenges of recognition, or work of, with just one vaccine, that may be the key to your future peace and quiet.
16/18

So, please don't make your response the same that Dr Tom Shimabukuro had when I asked for research, which was, "Thank him for his email, cut him off".
17/18

We were cut off, but we are still here.

Thank you for your time.
18/18

https://twitter.com/stormchaseguide/status/1618790086224801792?t=1k5JE9efbQKJDKV_pt2cVQ&s=19

I must regret I made a factual error in my #VRBPAC comments. I said Dr Tom Shimabukuro said "Thank him for his email, cut him off." He actually said, "Thank him for his email and cut him off." These were comments he made about me. I regret my error.