My name is Robert Edmonds, I am an admin of one of the actually smaller tinnitus adverse event focused support forums for COVID vaccines with nearly 1000 members.
2/21
The topic is of course of personal interest to me because I developed chronic tinnitus after my COVID vaccination.
3/21
This adverse event though isn't foreign to this committee, a prior member of yours, Dr Gregory Poland, continues to experience it as well, along with variability after being rechallenged as he has communicated in news sources.
4/21
So, please excuse this somewhat off topic diversion to discuss tinnitus, a symptom already mentioned on the label of some other vaccines.
5/21
Note, my following comments are not being made to dissuade vaccination, but to encourage official recognition so as to lead to research and early treatment of tinnitus with COVID vaccination.
6/21
With that being said, I will now review some important recent findings, to motivate this issue:
In a recent WHO Pharmaceutical Newsletter we find:
"the UMC identified hearing loss and tinnitus following COVID-19 vaccination as a preliminary signal"
7/21
& in JAMA Oto about recent analysis of data from Israel:
"This study suggests that the Pfizer mRNA COVID-19 vaccine might be associated with increased risk of SSNHL" & "Patients with SSNHL might experience permanent hearing loss and tinnitus"
8/21
Now, while I understand the VSD has not seen a clustering of cases for tinnitus, in Laryngoscope in an analysis of TriNetX Analytics Network data resulted in a finding that:
9/21
"patients with a predisposition to vaccine-related tinnitus may be more vulnerable after the first dose than after the second dose"
10/21
& In Drug Safety in another article but with FDA coauthors:
11/21
"investigation enabled us to discover 2 potentially new AEs (herpes zoster & tinnitus), which are yet to be recognized by health authorities, but which have overwhelming statistical support in VAERS & are supported by published case reports & studies"
12/21
& finally, while the prior papers mostly examined mRNA vaccines, in the meeting highlights of EMA's PRAC we have the statement that they:
13/21
"Concluded that cases of dizziness and tinnitus are linked to the administration of COVID-19 vaccine Janssen"
14/21
This is supported in part by a 15 versus 4 imbalance in COV3001, and their later recognition of another COVID vaccine of the same platform having this issue at an uncommon frequency.
15/21
With these repeated signals for tinnitus it is beyond time for US federal funding of research into this adverse event for COVID vaccines, and not just to tell us rates, but to investigate mechanisms and treatments.
16/21
& there may be a treatment for some with quick utilization of corticosteroids after onset, but so many miss out, if so.
17/21
That is why there is urgency for this issue, because we may be able to improve outcomes for others. I therefore call on you to advocate for research and recognition. Let us now help those that follow, help them find peace and quiet.
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
Got this from a reporter, Tom Shimabukuro at the CDC talking about me.
To clarify, there was no need for this response. I was sharing IRB approved survey data collected by a University of Arizona tinnitus researcher that had not been published.
Peer reviewed papers (not anecdotal case reports) and governmental sources that indicate a link of COVID vaccination to tinnitus (even if not after a first pass). Author affiliations include the @WHO, @EMA_News, & @US_FDA. A thread 🧵, with select quotes:
who.int/publications/i…
"A recent signal detection activity at the
Uppsala Monitoring Centre (UMC) identified
hearing loss (including sudden cases) and
tinnitus following COVID-19 vaccination as a
preliminary signal to be further assessed."
jamanetwork.com/journals/jamao…
"This study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of SSNHL" ... "Patients with SSNHL might experience permanent hearing loss and tinnitus..."
They explained what masking is, and the effect on the signal for tinnitus as an adverse event within VAERS. Let me explain what I learned: 🧵
1/8
What is masking you ask?
"The masking effect is a statistical issue associated with
commonly applied signal detection methodologies in
which signals for a product of interest are hidden by the
presence of other reported products."
2/8
That is, when looking from one vaccine to another we look at changes in passive reporting to look for increased reporting of a symptom. However, some vaccines produce the symptom of interest, so it makes it hard to see that a signal is there if you don't see a change.
3/8
I was told I'm supposed to come up with clear goals with my advocacy, because I run the risk of looking antivax:
Goal 1: The FDA/CDC/NIH formally supports research via funding exploring the mechanism of tinnitus as an AE, risk factors, and treatment methods.
1/N
Goal 2: The recognition of tinnitus as a related adverse event for at least 3-4 C19 vaccines. There is now sufficient evidence to support this claim through many peer reviewed publications.
Goal 1 & 2 go hand in hand really.
2/N
Goal 3: Informing patients and providers of what to do in the event this develops for others in the future. Both patients and providers don't know what to do, it appears corticosteroid ASAP near to onset may be beneficial.
3/N