Note: This post was recently linked in a NatGeo feature on vaccine safety (which I got to be a source for). I encourage you to check it out!
Today I’m going to try to do something that may be in vain. I’ve tried repeatedly throughout the pandemic to bridge opposing views on a number of issues. My recurring takeaway has been that while many people have noble goals, there is a depressing lack of collaborative spirit which makes discourse unproductive and often toxic (link related). This is not merely a musing but is instead central to today’s topic.
The issue of COVID vaccine adverse events is—from a scientific perspective—often amazingly straightforward. The politics of handling them: investigation, compensation, policy, etc., is not. But even then I’m really never confused as to what should happen. Moreso frustrated that our broken discourse fails to produce even the beginnings of a solution.
I’ve been able to see this issue from two different angles. For one, I am regularly exposed to the harms of COVID misinformation that exaggerates vaccine risks: I worked in a senior home network where outbreaks killed many, I’ve been hospitalized alongside people dying of this disease, and I now work for a pro-vaccine organization that gives me unmitigated access to the kind of misinfo that could have cost me my life. These unfounded rumors about vaccine side effects are lethal.
At the same time, I’ve met 2-3 people with genuine or plausible adverse reactions to COVID vaccines who’ve been put in a very difficult situation. This wasn’t chance: I constantly write about vaccines online for a wide audience, so even people with rare conditions manage to find me. People who had something unexpected happen to them, acknowledge that it may or may not have been related, yet never get real help or answers either way. And as a chronic illness patient I relate deeply to this sense of medical forlornness.
I’ve not been able to square these issues in a satisfying way: how to address their concerns publicly without scaring other people into making bad decisions. But recent events have made doing so necessary. So here’s my best shot.
Two Truths
I’m going to give you two foundational facts:
Vaccines are very safe, and their risks are well-established.
There isn’t a cover-up for adverse events.
These facts are true because vaccine safety is a dedicated science, and vaccines themselves one of the most scrutinized medical innovations. There is, or at least was, a plaque in front of the CDC library of someone who was “vaccine injured:” David Salamone whose contracting vaccine-derived polio led to nationwide change to inactivated polio vaccines. More recently, CDC scientists conducted in-depth case reviews using interdisciplinary teams for hundreds of *reported* AEs during the first few months of the COVID vaccine roll-out (more on this in a bit).
Meaning: anyone claiming some vast effort to hide claims of injury is wrong.
With that out of the way, let’s talk about the injuries that do happen.
Myocarditis (or AE Compensation)
Though COVID-19 vaccines are safe, they sometimes cause inflammation of the heart called myocarditis. I first heard about this condition in Spring of 2021 while working for the CDC & WHO partner: The Task Force for Global Health. I heard about it because our staff actually created the case definition for myocarditis as an adverse reaction. They were working on this at the beginning of March at the latest (see document history). At this point, first dose vaccine uptake among 18-29 year olds was less than 10%, meaning a tiny minority of myocarditis cases would have yet occurred since it typically occurs after the second dose (and smallpox vaccines for young military recruits mask the signal). That’s remarkable detection.
Fast forward to 2022. In my day-to-day work, I am constantly responding to rumors that COVID vaccines have cardiac risks being covered up or downplayed by the CDC. After months of debunking, I summarize my efforts in a 4000 word article entitled COVID Vaccines Don’t Cause Heart Disease which quickly becomes our top viewed web page. I wrote it because as a young male with a heart condition, the deluge of rumors had me worried too. Little did I know: a college student my age had died from COVID just months earlier believing the exact same thing.
It is thus very clear to me that how we handled the real risk of myocarditis allowed misinformation to flourish. Did it at least make life better for those actually affected?
The answer is no. My colleague Tara Haelle published an article on the exact same day as mine entitled: Why is it so hard to compensate people for serious vaccine side effects? The piece’s protagonist is teacher and mother Emily Ekanayake whose 14 year old son suffered from an unusually severe case of vaccine-induced myocarditis. Though he received excellent medical care Emily’s dilemma has been that their family was never compensated for this legitimate injury. In fact: no one in the United States has been compensated for myocarditis.
I’ve since met and chatted with Emily quite a bit. We don’t see eye to eye on everything, but I’ve tried to offer practical support. I interviewed a pediatric cardiologist who has treated myocarditis after meeting Emily and later helped connect them (as she wasn’t sure if she should vaccinate her other kid). Months later she would go on Tucker Carlson to tell her story. I didn’t think this was a good idea, but I called her to do some informal media training and sent along talking points to steer away from his anti-vaccine goals.
I learned—in the course of that call—that Emily wasn’t sure what it would take to reform the compensation system. That surprised me. But underlying it is a key fact: no one actually knows what the issue with compensation is.
I don’t blame her for this, nor any non-expert in health, but am disappointed that even the medical professionals who bring it up constantly haven’t educated the public. They’ve brought us to a point where despite talking about myocarditis all year neither the vaccine advocates nor the vaccine injured got what they wanted.
So if you want to meaningfully help either party, here’s what you need to know.
COVID Vaccine Injury Compensation
VICP vs. CICP (Much of this drawn from Tara Haelle’s Writing)
Vaccine injury compensation typically happens through a system called VICP, which is funded by a tax on every vaccine sold, almost as if a form of insurance. When someone claims they were injured, VICP will hear their case and pay for their attorney. The reviewers are medical/legal experts using a lower standard of evidence than would be required in a court of law.
Though if you lose your case you can then sue, VICP was established as an alternative to legal strategies. Legal challenges surrounding vaccines have always been hard to win and can take many years. This hurts the patient. On the other hand, lawyers aren’t medical experts, so cases have often decided not on the basis of evidence but the inherent chance of opinion and sheer volume. VICP was actually founded as the policy solution to false claims about the DTP vaccine flooding the legal system. While most people lost their case, the prospect of manufacturers taking huge losses caused many to pull out of the market entirely and led to a vaccine shortage. This is bad for literally everyone.
Anti-vaccine advocates will often complain that you can’t sue Pfizer for COVID vaccine injuries. Given this does not help those legitimately injured, this is because they 1) want the public antagonism that comes with lawsuits and 2) want vaccines off the market.
That said, COVID vaccines do not fall under VICP. They fall under an alternative called CICP which was designed for public health emergencies (to prevent liability concerns from stifling medical innovation). CICP—however—is a broken and useless system. You don’t really need to know the details because it has not paid out money to anyone.
Why CICP Sucks
Like most policies in the US, CICP is a product of its time and political context. President George W. Bush signed it into law in 2005 as part of the Public Readiness and Emergency Preparedness (PREP) Act. It followed from his national preparedness strategy to combat pandemic influenza, in which he asked Congress to give exceptional liability protections to vaccine manufacturers. As Stanford Law Professor Michelle Mello notes: “Subsequently adopted legislation has given producers of pandemic vaccines near-total immunity from civil lawsuits for vaccine-related injuries.”
Nothing since has stopped legislators from adapting that system. Presumably the best explanation for why nothing has been done was more general apathy towards the threat of a pandemic (for which we were also not prepared). As Prof. Mello wrote in 2008: “The threat of pandemic influenza – particularly now, when it is still theoretical – presents an opportunity to reconsider and rationalize these policies…rather than allowing policy flow from political expediency.”
Come 2021 we still had no real policy. Pro-vaccine Law Professor Dorit Reiss wrote an article less than one month after the vaccine roll-out entitled Congress Should Enact No-Fault Compensation for COVID-19 Vaccine Injuries. She explicitly noted: “Under the Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers and providers are immune from liability…But we have an alternative. The Vaccine Injury Compensation Program (VICP) provides compensation under a much more generous standard.”
Why hasn’t Congress done this? Actually: it has tried. A certain Democratic Representative named Lloyd Doggett introduced two bills last summer that would reform compensation:
The VICP Modernization Act (HR 3655): would make it easier to add vaccines to VICP, increase the time you have to file a claim, shorten the decision process, expand expert staff and raise maximum compensation.
The Vaccine Access Improvement Act (HR 3656): would automatically add an excise tax to vaccines recommended by the CDC and shorten the time HHS has to formally add vaccines to VICP.
Democratic Senator, Bob Casey, is sponsoring a companion bill in the Senate. I highlight that CICP was created by Republicans and recent solutions proposed by Democrats for a reason. There is a narrative among conservative politicians and media that liberals are hiding vaccine injuries and denying compensation to victims. Not so. Arguably, anti-vaccine myths plaguing Republican politics could further polarize and stymie better legislation.
Partisanship Vs. Reform
The reasons reform is stuck in limbo are twofold: 1) our country has been in crisis for several years now and 2) vicious partisan competition makes focusing on & addressing niche issues impossible. As Tara Haelle writes: “With the extreme partisanship in U.S. politics right now and the many other priorities Congress faces…most legislation needs to be part of bigger packages these days. It’s a lot harder for a single bill to go far.”
This partisanship is why Dorit, Tara and I were all worried about Emily’s Tucker Carlson appearance, even though we get the impulse. Emily is not at all anti-vaccine but Tucker certainly is. I also learned of another woman named Brianne Dressen who reportedly got long COVID from the vaccine. This is plausible, but to get the word out she joined in on Senator Ron Johnson’s anti-vaccine press conference in June of 2021.
Both of these conservative pundits lie everyday about COVID. If they had serious goals, they’d support Doggett’s legislation. Or they’d have brought up any of the seven dedicated vaccine adverse events research centers in the United States (more on this in a moment). But they don’t because they don’t actually care about the vaccine injured.
My advice then is this: if you think you’ve been injured by a vaccine, you’re better off avoiding these people. And I don’t just mean politicians. I mean all the backseat commentators who became experts on this subject via tweet, and who use myocarditis as a tool to create division, anger and general distrust of medicine. And to her credit Emily has at times stood up directly to large figures who create drama over myocarditis and misuse her son’s example.
In response, I will do my best to raise awareness of meaningful solutions (as I’ve tried to here). Your honest opinion on how I could do better is always welcome.
Tinnitus (or AE Treatment)
I now want to move onto a second example of a potential AE, one you may not actually have heard of: tinnitus. Tinnitus—a ringing in the ears, of varying severity—is not recognized as an adverse event of COVID vaccines in the US, but with some of the current advocacy surrounding it that could change. Enter Robert Edmonds.
Edmonds is a man who says he developed tinnitus after receiving his COVID vaccine. At first, he didn’t suspect the two were related at all, and he gladly told his wife to get vaccinated. But after going back and forth with some of his doctors it was suggested to him that perhaps they might be connected. Unable to get rid of this now quite bothersome ringing, which was loud enough to disrupt sleep, he began to visit specialists and look to see if anyone else had a similar experience.
From the perspective of care, Edmonds would go through what many patients with inexplicable illness have experienced: cycling through different drugs to see if anything helped. This included multiple medications with side-effects that left him exhausted for almost a year. Ultimately he found one which did help somewhat (Diamox): “It makes the ringing quiet enough that at least the car radio can drown it out.” But his providers can’t say if it will get any better.
Edmonds is pessimistic from his interactions with others. He has become a kind of patient advocate, running a website for people who say they’ve also experienced tinnitus following the COVID vaccine. He says very few seem to recover completely, perhaps because there is no ‘protocol’ for what to do in the event that tinnitus begins to develop. He stresses that he is strongly pro-vaccine and even got his COVID-19 booster. His goal then is to help identify whether or not the relationship with tinnitus is causal or correlational, and to help others receive proper care (irrespective of the cause).
AEs vs. Complex Illness More Broadly
Edmonds advocacy is—I have to note—unreasonably persistent for the average person. He’s well-educated with a PhD in the natural sciences, friends with scientists and familiar with researchers, and financially secure enough to visit multiple specialists. I would say that he represents a best-case scenario for someone beset with a complicated illness. If even he is still unsure what to do next in terms of treatment, possible compensation, etc., your average person really won’t get far.
That said, I don’t think this inherently has anything to do with vaccines. I found Robert’s story interesting because my own health condition is quite rare, and I’ve also struggled to find proper care. Before I finished my education and started working in health I just lived with chronic symptoms (mainly fatigue). This is an unfortunately common experience.
In fact, a 2016 study in JAMA estimated that while some 21.4 million Americans experience tinnitus, only 50% had even asked their primary care doctor about it and a mere 15% had tried anything to help with it. The study also notes that research on treatment is still developing, and that the first high quality, standard guidelines for care were only published in 2014. So if we don’t understand or treat tinnitus in general we’re obviously not going to handle it well as a much rarer and poorly understood side effect. But not all is lost…
CISA: A Better Treatment Route
Given Edmond’s main goal is to improve case management, I was surprised he hadn’t heard of CISA: The Clinical Immunization Safety Assessment Project. CISA is a CDC project started in 2001 that serves as the third and final part in a vaccine safety monitoring system. Wherein VAERS finds AEs, VSD confirms them, and CISA helps treat them.
As one paper in Pediatrics explains: “VAERS identifies signals of potential adverse events, the VSD investigates the epidemiological and statistical significance of those signals, and the CISA Network conducts clinical research studies to evaluate these adverse events, including their pathogenesis and possible causal relationships with vaccine, and provides advice and algorithms regarding management and administration of subsequent doses of vaccine.”
CISA involves a network of about seven centers across the US, and is subdivided into a number of working groups. Any healthcare provider can call them, and if available they’ll assign experts to review the case, ask for any further relevant info and request labs, and provide a course of action for the patient.
Their investigations are often extremely thorough because they need to determine what exactly caused the patient’s symptoms, and if they can be re-vaccinated or receive other vaccines (see case studies here). Data show the large majority of doctors (93%) are satisfied with their assistance, and most of the patients for which follow-up data was available felt confident enough to get vaccinated again.
CISA’s overarching goal is for the doctors conducting these reviews to become experts in treating adverse events (they’ve offered fellowships in vaccine safety). The seven CISA sites at different medical facilities are supposed to become respected treatment centers, the likes of which we have for plenty of other rare conditions. I’d note from personal experience that these kinds of specialty centers are often overbooked / not well understood by the public. And the data bear that out: the large majority of CISA call-ins are from doctors in the area around them.
If you are a patient concerned about a potential adverse event, my advice to you is to specifically ask your doctor to call for a consultation. Read-up and prepare your advance in request. This is the same kind of self-advocacy advice the CDC gives to patients requesting care for a complex condition like CFS because doctors are not accustomed to dealing with them. They mean well but they’re incredibly busy, and may refer you to someone else if they feel unqualified or fail to understand the proper importance of what you’re asking.
From the requests that CISA did receive, they were able to consult for 331 patients in the first two months of the vaccine roll-out. Their second most common inquiry was nervous system disorders, which would include tinnitus.
I wish CDC had done better to make providers aware of this service but I expect some change is coming.
Brighton: Hope on the Horizon
I mentioned earlier that my employer created the case definition for myocarditis. This was the work of a program known as the Brighton Collaboration, founded by former CDC scientist Robert Chen. Chen not only helped create CISA but also led vaccine safety at the CDC for roughly ten years. His current work at Brighton combines decades of experience trying to create a better system for defining adverse events and helping people who suffer from them.
This is another organization where I’m surprised Edmonds haven’t heard of it, because it really is everything you could hope for. Brighton’s Guiding Principles, Scientific Priorities and Methods emphasize:
A patient focused approach: “Everything we do is for the purpose of providing vaccine stakeholders with the best possible information so they can make the best possible decisions.”
Better case management: “When it comes to AEs, rapid response is required. We leverage the community’s expertise for rapid information exchange.”
Standard definitions and improved reporting for epidemiological purposes: “Large data sets are required to estimate the risk of adverse events. We promote the conduct of international collaborative observational studies.”
Making their work accessible to lower barriers to patient & provider awareness: “We enhance local vaccine safety expertise through collaborative projects and knowledge transfer.”
This is—of course—a monumental undertaking, and the first time Brighton’s case definitions were widely used was a little over ten years ago during the H1N1 pandemic (years after the organization’s creation). But Chen has pioneered both the CISA model and now a collaborative global safety network, both of which are products of US public health and quite likely the best systems in the world. These systems are better than those available for many, many health conditions people suffer from: some rare, and some not.
Just last week, Chen told me that Brighton had added tinnitus to their adverse events of interest list (on which myocarditis, long COVID and others have been for a while now). I don’t know why it has taken so long but I also believe they’d be the one of the first organizations to systematically address it.
I suspect we could have gotten to this point faster if patients had reached out (and, because some have, if they were listened to). For instance, I helped connect Robert Edmonds to Patsy Stinchfield who just recently finished a term on ACIP (and was also a voting member from 2004 to 2008). She then reached out to the current head of vaccine safety at CDC and asked him to add tinnitus to VSafe, CDC’s phone-based AE signal detection system. Since organizations like Brighton have access to that kind of data it likely would have moved things forward.
And moreover: I sit in monthly meetings with Brighton staff. Just like all of our other public health partners they function through collaboration, so outreach is essential.
One Caveat, in Conclusion
My hope in outlining all this is to create a guide for productive engagement. I understand the frustrations of people who have to go through any complicated illness, whether or not it’s related to a vaccine. However: we have to be careful not to take out our frustrations on individual public health workers.
The one place where I disagree with Robert Edmonds is that he sometimes seems to get angry with people who are sympathetic to his situation or even trying to help. Some of them are my allies and colleagues, and some of them (such as Patsy and Dorit Reiss) have even made active efforts to improve monitoring & compensation.
After all he has gone through that doesn’t cancel out his advocacy. And to be clear: the pro-vaccine community could do more, and maybe clams up too easily in response to someone who is reasonably upset. But as I said for myocarditis, I just don’t think antagonism helps anyone. It’s not something I’d state so frankly if I weren’t a frequent and sometimes unsatisfied patient myself.
Let’s each communicate with a sense of who needs what, what resources are out there, and which discrete actions can we take to move everything forward. No one should suffer needlessly and none of us want that for anyone.
Good luck and good health friends 🧡
Update: I’ve also been notified that INSIS—an international vaccine safety monitoring system—has just started a monthly call to review evidence on tinnitus.
Dr. Chen notes that the vaccine safety review process usually goes from case studies → case series → controlled studies. INSIS is better geared towards handling case series than Brighton and could help facilitate that next major step in research.
