The story I published in National Geographic on vaccine injuries began in mid-August 2021, when Emily Ekanayake told me on Twitter about her son’s myocarditis and her mounting medical bills. (Note: If you haven’t read that story, it makes more sense to read that before this one. Enter any email to read it.) I wasn’t surprised that her son had experienced myocarditis — it’s well established as linked to mRNA vaccines, particularly for male adolescents. But I was surprised to hear that myocarditis might not be covered as a vaccine injury under the compensation programs that exist specifically to address the expenses associated with proven vaccine injuries. I knew that COVID-19 vaccines fell under the countermeasure program and hadn’t been added yet to the vaccine program, but I wasn’t aware of just how different the programs are, or of how slow the vaccine program had become as more vaccines had been added to it over the years.

I’m keenly aware of the importance of stories in helping people make sense of science. (Obviously — I’m a science journalist!) Often it’s stories told by anti-vaccine activists that frighten parents away from vaccinating their children, even if the story isn’t true. But stories about genuine vaccine injuries are also important. Anyone touting the benefits of vaccination who doesn’t acknowledge the very rare but very real and serious injuries that can occur can’t be taken seriously. That’s why I spent the past seven or so months reporting this story. I cannot report on the safety and effectiveness of vaccines, as I have for over a decade, without also examining the real risks of vaccines, however small or rare they may be.

But doing so meant turning in a first draft that was over 6,000 words. (I called my editor to break the news to her on the phone because I needed to make sure she was sitting down when she found out.) Over multiple edits, it was whittled down to 3,300 words, and then ended up at 3,700 words. I’m very happy with the story and the phenomenal job my editors did in helping me streamline it, but there’s still so much that got cut that I think is worth sharing, including answers from Health and Human Services to the many questions I sent them. So I’m doing that here.

The day before my story was published, I sat reviewing the final draft at a clinic in Frisco, Texas, where I had just received an experimental vaccine from Moderna. I had just enrolled in Moderna’s clinical trial for an omicron booster, and I was waiting the required 30 minutes after the shot to be sure I didn’t have any allergic reactions. I was thrilled to participate in the trial and potentially gain some immunity against the Omicron variant, yet the story I was looking over was about people who had experienced severe adverse effects from a vaccine very similar to the one I received.

Perhaps this seems ironic, but I see it as consistent with how I perceive the scientific process and what vaccines offer. Vaccines are a marvel of human ingenuity and hard work, but they have limits. Clinical trials need volunteers to ensure that vaccines are as safe and effective as possible before they go out to the wider world, but vaccines will never be without risk. Nothing in life is 100% safe, and although scientists work to make vaccines as safe as they possibly can, severe adverse effects will always occur to a very tiny percentage of people who receive them. Those people matter just as much as those whose lives are saved by vaccination, and I do think “pro-vaccine advocates,” in their understandable zeal to promote vaccination and debunk misconceptions or conspiracy theories about vaccines, can tend to forget that people legitimately injured by vaccines need care, attention, and acknowledgement as well.

Genuine vaccine injuries may be extremely rare, but when you’re giving 215 million people a vaccine, even a tiny, tiny percentage can become thousands of cases. For example, thrombosis with thrombocytopenia syndrome (TTS), is a blood clot condition that occurs in approximately four out of one million doses of the J&J vaccine. If all 215 million people who are fully vaccinated in the U.S. had received that vaccine, that’s still more than 800 cases of life-threatening blood clots. (Hence the reason the CDC now recommends mRNA vaccines over the J&J one.)

The challenge is figuring out who has experienced an injury that we can be reasonably sure was probably caused by a vaccine, versus those health events that occur or are identified after a vaccine but which aren’t related to it. Some cases are clear cut because we have loads of evidence, such as myocarditis after mRNA vaccines or TTS after the J&J shot. But very rare conditions may be difficult to link to a vaccine when there aren’t enough people experiencing it to have the evidence necessary to assess it.

Other conditions may be so common that it’s not possible to separate the background rate from the cases that occur after the vaccine. One of the stories I didn’t include in my article is that of Robert Edmonds, who developed tinnitus after the Moderna vaccine. Thousands of others have reported a similar experience, including Gregory Poland, a prominent vaccine scientists I’ve interviewed many times. The problem is that tinnitus can affect anywhere from 8% to 25% of the US population. If up to one in four people has the condition, it becomes far more difficult to determine whether tinnitus occurred because of a vaccine or simply after the vaccine.

And that’s why the vaccine court exists, to try to pick apart those ambiguities. It’s also why the vaccine court uses the lowest burden of proof possible — a preponderance of evidence — for a plaintiff to win. It’s commonly referred to “50% and a feather,” because it only takes the tiniest fraction of evidence to tilt the scale from “not caused by vaccine” to “maybe possibly plausibly could have been caused by vaccine.” As Dorit Reiss, a law professor specializing in vaccine law, put it, ”For regular court, you would need scientific evidence, but here, a plausible theory from an expert is enough.”

But that’s not how the Countermeasure Vaccine Injury Program works. Their standard requires claimants to provide “compelling, reliable, valid, medical and scientific evidence” that the injury was caused by a COVID vaccine. But what exactly does that mean? It took multiple back-and-forths with the press officers at Health and Human Services to get an answer that was satisfactory, but we finally got there: “This is a unique legal standard established by statute, and is a higher standard than, for example, the preponderance of the evidence standard,” David Bowman, the HHS spokesperson, told me via email. It’s still not clear to me what would or wouldn’t meet that criteria, but at the very least, I know it requires more for CICP than it does for VICP. And that’s not fair, equitable, or just.

CICP and VICP: Transparency Is the Difference

I’ve outlined in the National Geographic story the many other differences between the VICP and CICP programs (here’s the government’s comparison), so I won’t reiterate them here, but I want to draw extra attention to the substantial difference in transparency between the programs. If I submit a claim to VICP, I know which of the special masters — the administrative judges who decide cases — is handling my case. If my lawyer and I aren’t happy with the judgment, the appeal process is straightforward and transparent, similar to other civil courts’ appeals, all the way up to the Supreme Court. (Fewer than a dozen VICP cases have made it to the Supreme Court, but some have.)

In CICP, once I submit my claim — which I have to do by myself since the program doesn’t pay for a vaccine injury lawyer as VICP does — it goes to one of 14 medical reviewers in HHS. They’re all physicians or nurses, but I don’t know their names, their qualifications, their specialties or fields, their experience… I know nothing about them, or their biases, since we all have bias. And that one person I don’t know makes a decision about my case. If I don’t like the decision, I can ask for reconsideration by “a qualified panel, independent of the program,” that convenes to review my case, according to Bowman. But “independent” simply means they aren’t CICP staff. Instead, they’re “U.S. Public Health Service Commissioned Officers who are health care professionals (e.g., physicians, nurses, physician assistants) who may work for HHS or another federal agency,” Bowman wrote.

When the FDA and CDC have independent committees, such as the Advisory Committee on Immunization Practices (ACIP) or Vaccines and Related Biological Products Advisory Committee (VRBPAC), independent means the members are not federal employees. They’re truly independent, from outside the government bureaucracy. That’s not the case here. ”When you keep the thing as an administrative process, you control that process completely,” Michael Milmoe, a vaccine injury lawyer, told me. He should know: before he joined his partner’s firm representing people with vaccine injuries, he spent nearly three decades in the Department of Justice defending the government against people with vaccine injuries in the VICP program. He’s been on both sides, and he was at VICP from the day it began in 1988.

Even if the committee reconsidering my claim was truly independent, it may not matter. The final decision resides not with a judge but with the Associate Administrator of the Health Systems Bureau of HRSA, currently Cheryl Dammons. After she makes her decision, it’s over. There’s no other appeal.

Finally, aside from transparency, it’s impossible to ignore the huge disparity in the programs’ budgets. VICP has more than $4 billion to work with — more on that further down — but CICP had only $5.8 million for 2021 and $5 million requested for 2022. The department can ask for more, but I don’t see how nearly $11 million will come close to covering the number of legitimate claims that will exist for myocarditis, TTS blood clots, Guillain-Barre syndrome, and other injuries that ample evidence has linked to COVID vaccines. Of course, CICP doesn’t cover pain and suffering and has a wage cap — both major problems, especially if tinnitus is determined to be related to the vaccines — but even without considering costs of pain and suffering, that’s not a lot of money to work with, particularly when the government spent $5 billion developing COVID vaccines.

Unsatisfactory Responses from HHS

I sent HHS loads of questions while I reported this article, and they faithfully responded to all of them in a timely fashion. I am grateful to the public officers who did that. The problem — which is not the fault of the press officers — is that few of the answers truly addressed the crux of my question. The most concerning of these was HHS’s inability to answer what I thought should have been a very straightforward question: If a person files a claim under CICP, can they later file a claim under VICP and still receive compensation (whether they received it under CICP or not)? The response: “At present, no COVID-19 vaccine is covered by the VICP. We cannot speculate about future actions.” I asked a variation of that question again several more times — once in a question over 400 words long — and the final response was “The process for adding a vaccine to the VICP requires congressional action.”

That leaves vaccine injury lawyers and those with injuries in limbo, uncertain whether applying to CICP would block them from receiving additional VICP compensation for pain and suffering or additional lost wages when the vaccine is eventually added to VICP. Cody Robinson, for example, has lost much more in wages than the $50,000 cap on wages reimbursement in the CICP program. VICP has no cap on wages — but if Robinson applies to CICP and receives $50,000 for those lost wages, no one knows if he can later try to recoup more of his lost wages above and beyond that $50,000 by filing to VICP. For all we know right now, filing to CICP could disqualify a later claim to VICP. “Nobody knows the answer to these things,” Milmoe told me.

HHS also couldn’t clarify questions I had about the process of adding COVID vaccines to VICP. I genuinely believe they gave me all the information they could, but that was even more disturbing — I don’t think anyone in HHS actually knows the answers to the questions I had, and they absolutely should. For example, vaccines can be added to VICP after the CDC “routinely” recommends them for children or during pregnancy. But “routine” is not defined anywhere in the 1986 National Childhood Vaccine Injury Act. HHS initially told me that it “treated ACIP recommendations approved by the CDC Director and published in the Morbidity and Mortality Weekly Report as fulfilling this requirement.” But when I asked whether COVID vaccines would qualify as “routine” under this definition, HHS said, “We cannot speculate on determinations that might be made in the future.”

I also couldn’t learn whether adding one COVID vaccine meant adding all of them. Only the Pfizer vaccine is recommended for anyone under 18, and both mRNA vaccines are recommended during pregnancy. But the J&J vaccine is not recommended for anyone under 18 or during pregnancy. “The wording of the excise tax language determines whether the entire category of COVID-19 vaccines would be covered or whether specific types of COVID-19 vaccines would be covered by the VICP,” Bowman at HHS told me when I asked about this.

That means Congress needs to be very conscientious in wording the language for the excise tax. If it speaks of “COVID-19 vaccines” as a group, then vaccine injuries from J&J shots would ultimately end up covered by VICP. But if it’s worded only to include mRNA vaccines, since they meet the children/pregnant women recommendation criteria, all the people with J&J vaccine injuries — which are some of the most severe — are left in the cold.

No CICP Injury Table

Finally, I was frustrated with the HHS’s given reason for not yet having a CICP injury table for COVID vaccines. “An injury table for COVID-19 medical countermeasures will be developed when there is sufficient data to meet the ‘compelling, reliable, valid, medical and scientific evidence; standard indicating that the covered countermeasure directly causes a particular injury,” Bowman at HHS told me. At the time I’m writing this, PubMed pulls up 68 results for a tightly focused search on myocarditis and COVID-19 vaccines. There is no scientific ambiguity about it: the mRNA vaccines can very clearly cause myocarditis in rare cases. What more does HHS need for an injury table? We’ve had this data for months. I asked several experts if they thought, at the very least, that myocarditis and TTS ought to qualify for an injury table.

“My feeling is both myocarditis after mRNA vaccines and TTS after J&J would meet criteria for being added to compensation,” said Walter Orenstein, a professor and associate director of the Emory Vaccine Center in Atlanta who has studied VICP. He pointed to the CDC’s COVID vaccine safety page clearly listing both as possible adverse events. “They are generally accepted to be causally related to COVID-19 vaccines albeit rare.”

Michael Portman, director of pediatric cardiovascular research at Seattle Children’s Hospital, who I interviewed for my National Geographic story on myocarditis, also noted that the CDC has recognized myocarditis as an adverse event, and his clinic has findings that abnormalities persist.

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, agreed. “I think that all reliable evidence supports that fact that mRNA vaccines are a rare cause myocarditis and that vectored adenovirus vaccines are a rare of cause of TTS,” he said.

It’s worth noting that if and when CICP does develop an injury table, ”requesters who previously could not establish a table injury have one year from the effective date of the table or amendment to file a request for benefits, even if a previous request was denied,” Bowman at HHS said. An injury table has the potential to speed up the process of reimbursement, but it’s hard to tell if one will ever be developed. Even without one, it’s not clear how long petitioners are expected to wait before they get an answer.

No one I interviewed has received a response yet from HHS. Bowman did tell me that 85% of those who have filed claims have not provided the necessary documentation, but without a lawyer to guide them, I wonder how easy it is to gather everything necessary. And when I asked HHS how long it takes to process a claim once they do have all their medical documentation, the response was, “the CICP is working to process claims as quickly as possible.”

The Tsunami Headed toward VICP

As I noted in the National Geographic story, adding COVID vaccines to VICP doesn’t solve the bigger problem that VICP is so backlogged it takes years for people to get a response and their compensation. Medical billers don’t wait that long to get their payments, so a program that should prevent bankruptcies doesn’t help people at all when they actually need it most. (That’s why Chelsea Giovanni, whose son Kam experienced myocarditis after a Pfizer vaccination, set up a GoFundMe for their hospital bills.)

“Nobody was thinking about vaccines for pandemic use,” said Marcuse Edgar, an emeritus professor of pediatrics at the University of Washington who was involved in the sausage-making that became the 1986 Childhood Vaccine Injury Act.

Hence the importance of reforming VICP, as U.S. Rep. Lloyd Doggett’s Vaccine Injury Compensation Modernization Act of 2021 (HR 3655) would do. Two of the most important things that bill does is expand VICP to include adult vaccines and expand the number of special masters making the decisions. The shingles vaccine Shingrix, for example, is known to have some strong side effects, and I’m aware of at least one person — a vaccine advocate much less — who had significant problems after getting the Shingrix vaccine. But a shingles vaccine will never be recommended for children or during pregnancy, so it will never be included in VICP without a change to the law.

And until the COVID vaccines were specifically recommended for teens and during pregnancy, COVID vaccines didn’t have any chance of being added to the table. That’s particularly problematic when President Joe Biden was proposing vaccine requirements for substantial swaths of the adult population.

“There are clear mandates for adults that didn’t really exist until now,” Offit said. If someone is required to get a vaccine and then suffers a genuine vaccine injury, they should be compensated for it, he says. “We need to treat people fairly.”

Doggett’s bill would change the number of special masters from a maximum of eight to a minimum of 10, something utterly essential before COVID vaccines are added or else “the court would implode,” said Anne Toale, a vaccine injury lawyer in Florida. She said more than 1,000 people have contacted her firm asking for help with COVID vaccine injuries (which she can’t provide until they’re added to VICP).

HHS needs to hire more medical reviewers, something Milmoe and Renee Gentry, who directs the Vaccine Injury Litigation Clinic at the George Washington University Law School, said needs to happen. Neither of them understands why it hasn’t happened when the Department of Justice hired more lawyers to manage the caseload. Milmoe said the focus in the beginning was to ensure the program paid out fairly, generously, and quickly once a person was found to have a vaccine injury, but he doesn’t think the program today is what Congress envisioned. In fact, he frequently mentioned during our conversation that today’s court is more adversarial than it was when it began.

One thing Doggett’s bill doesn’t do is expand the ways the excise tax funds can be used, which Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins and a former director of vaccine safety at the National Vaccine Program Office, believes is crucial to improve the safety of vaccines.

“If your goal is to characterize and reduce adverse reactions and compensate those people who are injured, then the resources, and especially the excise tax, need to be used for vaccine safety science and to evaluate that science and update the [vaccine injury] table,” Salmon said. He does much of that vaccine safety research himself, so he knows it’s costly, but it’s also essential if the ultimate goal is to truly improve the safety of vaccines, as the 1986 law was supposed to do.

Time to Open Pandora’s Box

Every expert I spoke to about Doggett’s VICP reform bill, however, expressed little hope that it would go anywhere. With the extreme partisanship in U.S. politics right now and the many other priorities Congress faces — infrastructure issues, continued COVID-19 funding, a potentially imminent world war if Putin doesn’t leave Ukraine — it’s hard to see how the bill can muscle its way in. One Congressional aide told me on background that most legislation needs to be part of bigger packages these days. It’s a lot harder for a single bill to go far.

But the bigger hurdle to the bill is the fear of what comes along with diving back into the world of vaccine injury legislation.

“It’s like Pandora’s box,” Salmon said, with the specter of advocates and lobbyists converging on the Hill to shape the bill into what they believe it should be. “That’s been a long-standing argument for why we shouldn’t try to make changes to the program, but my belief is we need to open up Pandora’s box and make it better.”

Anna Kirkland, a professor at the University of Michigan and the author of Vaccine Court: The Law and Politics of Injury, said that long-standing fear is the reason the program hasn’t already been reformed. “There was widespread agreement on all the ways the program needed to be improved, but it was just too volatile,” she says.

Jason Schwartz, an associate professor of public health at Yale, laid out the concern plainly: “There’s a risk that if these programs come under the microscope among legislators who show sympathies for some of the more far-fetched and unproven theories, there’s always that existential threat that changes by legislators could expand definitions of compensation to suggest vaccine-related injuries that are not supported by the science,” thereby fueling vaccine hesitancy and misinformation rather than actually helping those harmed by vaccines.

“Once you open that box, the personal injury lawyers come pouring in with their goal to make it as broad and easy as possible to get compensation for injuries that aren’t injuries,” Offit said.

David Gorski, a surgical oncologist who has blogged about the anti-vaccine movement for nearly two decades, echoed those concerns, saying there would be a “huge amount of pressure to water down the vaccine court so it’s a much less effective firewall against the mass chaos of unlimited lawsuits that led to the law in the first place.” But that doesn’t mean it shouldn’t happen, he says, raising the question: “If not now, then when? I don’t see the situation getting any better.”

Gorski’s response led me to wonder what Barbara Loe Fisher might think about how VICP has turned out today. Fisher, a parent who alleged her son experienced a vaccine injury from the diphtheria-pertussis-tetanus (DPT) vaccine, formed a parent advocacy group in the early 1980s that led the push resulting in the law. That slew of lawsuits I referred to in the National Geographic story primarily centered on the DPT vaccine and parents’ claims that their child developed seizure disorders or brain damage from the vaccine. The DPT vaccine can, in fact, cause febrile (fever-caused) fevers, though febrile seizures do not cause long-term damage, and there still is not good evidence to suggest the DPT vaccine caused seizure disorders. (Those who developed seizure disorders after their DPT shot were later found to have a genetic disorder called Dravet syndrome. A seizure after the DPT vaccine may have been their first seizure, but evidence suggested the vaccine didn’t cause the disorder. DPT was replaced with the less reactive DTaP vaccine in 1997.)

But it was the fact that several rulings awarded damages to parents — even if there wasn’t adequate scientific evidence to show a vaccine caused the injury — that led to the wave of lawsuits that then made the 1986 law necessary. Fisher played an important, and admirable, part in that process. She testified in Congress and later served on several federal vaccine safety advisory groups. Today, Fisher is president of the National Vaccine Information Center, widely regarded by the scientific establishment as a major anti-vaccine organization. She declined an interview with me, which I understood since I have previously referred to her as anti-vaccine, but I was grateful that she responded to me regardless. She pointed to multiple statements from her organization about its stances toward the 1986 law and its operation today and provided me a statement:

”NVIC supports implementation of the 1986 Act as originally passed and enacted in 1986 before congressional amendments, rule making by DHHS, and a fatally flawed ruling by the U.S. Supreme Court in 2011 compromised the spirit and intent of the law with regard to prevention of vaccine injuries and deaths and compensation for the vaccine injured,” she wrote in an email. The 2011 ruling refers to the court interpreting the law to mean parents could not sue manufacturers on the basis that vaccine design was dangerously defective, Reiss told me.

People with Vaccine Injuries Aren’t “Anti-Vaccine”

While Fisher is widely regarded in the medical community as anti-vaccine today, that’s not necessarily the case of every person who has experienced a vaccine injury. One of the things that struck me most during the reporting this story was how painful it was to people with genuine vaccine injuries to be dismissed as “anti-vaccine” when they tried to bring attention to their concerns. I watched it happen myself multiple times on social media, and it’s inexcusable, especially by vaccine advocates. I know “pro-vaccine” folks have been viciously attacked by anti-vaccine activists, so I get the knee-jerk response some have to hearing about a vaccine injury. But that response engenders more distrust when they react poorly to someone with a true injury, whether it’s denying it or dismissing the mental anguish associated with it. For example, the teen boys who developed myocarditis after the Pfizer shot will, as far as we can tell so far, recover fully. But that doesn’t undo the pain they experienced or the terror their parents felt watching their boys undergo testing for multiple days in a hospital.

Ekanayake believes everyone should get vaccinated, but she remains concerned that teen boys’ only option right now is the Pfizer vaccine since the myocarditis risk from the vaccine is higher in that population. She’d like to see studies with smaller doses to see if that reduces the risk of heart inflammation. She says this issue seems to transcend the divide between “pro-vaccine” and “anti-vaccine” camps in that everyone agrees vaccine injuries should be compensated by the government.

“I understand the need for herd immunity. I understand the need for vaccinations,” Jessica McFadden, who had several massive blood clots from the J&J vaccine, told me. “What I don’t understand is the lack of empathy and concern for the individuals who could be impacted by it.” In fact, McFadden even asked her doctor after her experience whether she could get vaccinated with one of the mRNA vaccines. That’s hardly anti-vaccine.

Robinson expressed greater frustration about vaccine mandates, echoing much of the “vaccine choice” language that has been adopted by many in the anti-vaccine community. But again, it was evident talking to him that, even though he clearly opposed vaccine mandates, he didn’t oppose vaccines. He had gone out of his way to make sure his mother got vaccinated when she became eligible, and he encourages it for others as well. His doctor had told him it wasn’t necessary to get the vaccine so soon after his COVID infection, and at the time he got his J&J shot, there were genuine questions about how long after an infection someone should wait before getting vaccinated.

“I was feeling completely let down and hopeless, just completely disillusioned with everything people had told me, that I should stop being selfish and ‘man up’ to take the vaccine,” he said. His frustration was compounded by the fact that he can’t sue J&J if the claim with CICP doesn’t go anywhere, something people filing in VICP can do aside from suits about a defective vaccine design.

The bottom line was summarized best by Milmoe, who spent most of his career working in VICP. “The CICP program is not real, meaningful compensation for people who have serious injuries from the coronavirus vaccine,” Milmoe said. “If this country is really serious about wanting every single person to be vaccinated, then there has to be a place for people to go who are injured by the vaccine to be compensated fairly, and the CICP is no such place.”