COVID-vaccine victims face off against federal bureau that's gone silent

Within a few weeks, neurologists affiliated with Massachusetts General Hospital diagnosed her with several serious conditions they say were a result of her COVID-19 vaccine, including small-fiber neuropathy (which causes a painful tingling in the extremities) and Sjögren’s Syndrome (which leaves patients pained and fatigued, and in extreme cases, can damage internal organs).  

This shot, which was supposed to get Fox back to normal, instead left her with diminished ability to work and enjoy life. Persistent physical therapy and experimental treatments she’s taken since have done little to alleviate her symptoms.  

“I used to do so much, and now it’s a struggle,” she says. “Sometimes you just get down.” 

With her medical bills mounting and her condition not improving, Fox sought compensation for her damaged health. Federal liability protections prevent the vaccine-injured from directly suing vaccine manufacturers like Johnson & Johnson. Instead, claimants have to go to the federal government for compensation.  

But as Fox would soon learn, the government has two starkly different injury programs for vaccines. One operates like a civil court with a neutral judge, lawyers on both sides, and a guaranteed right of appeal. In recent decades, it has approved about 75% of claims and pays out hundreds of millions of dollars per year.  

The other, which handles COVID-19 vaccines, has rejected almost every claim brought to it, awarding less than $10,000 since the pandemic. And in a nation nearly numb to the pandemic's toll and its scandals, the program is adding seething frustration atop lasting injury to Fox and people like her in a little reported aftermath to the government’s much criticized performance on vaccines – ranging from erratic booster advice to broad-brush vaccine mandates that cost people their jobs. 

Fox filed her claim two years ago, submitting hundreds of pages of medical documents about her condition and diagnoses. She’s nevertheless one of the 10,887 people still waiting on a decision. “You’re not even hearing anything from the organization that’s supposed be helping you,” she says. “The phone keeps ringing, no one is emailing, nobody is doing anything.”   

The federal agency overseeing the program, the Health Resources and Services Administration, said in a statement to RealClearInvestigations that the current number of claims “significantly exceeds the previous volume in the program” and that the program has “hired additional staff to address this growth in claims, and the President’s budget requests additional funding to support the additional staffing needed to process claims.”  

Tale of Two Compensation Programs 

The government’s two contrasting vaccine compensation programs are similarly named and thus easily confused. The first, Vaccine Injury Compensation Program (VICP) was created in the 1980s and covers most routine vaccines. The second, the Countermeasures Injury Compensation Program (CICP), is a result of war-on-terror legislation in 2005 and now covers COVID-19 vaccines. Their bureaucratic differences help explain why a nation that has spent trillions of dollars on COVID relief programs has provided almost no assistance to people harmed by the vaccines that the government encouraged, and sometimes required, them to take. 

The earlier program was supposed to shore up pharmaceutical companies’ willingness to make childhood vaccines in the face of persistent vaccine injury lawsuits, while also giving the vaccine-injured a fair and expedited process for compensation.  

The vaccine-injured would not sue pharmaceutical companies. Instead, they’d petition the government in Federal Claims Court, where special masters (judges) would decide cases. Compensation came from a government-administered trust fund paid for by excise taxes levied on vaccine manufacturers.  

Between 2006 and 2021, this court adjudicated cases from 10,602 petitioners and issued compensation to 7,618 of them. The compensation trust fund sits at $4 billion and pays out about $200 million in compensation and attorneys’ fees each year.  

This earlier program bears little resemblance to the Countermeasures Injury Compensation Program, where the COVID-vaccine cases of Fox and many others are languishing. 

It was meant to incentivize pharmaceutical companies to be part of the federal response to one-off, one-in-a-million events like a bioweapon attack or an outbreak of a deadly pandemic. Although almost one billion doses of COVID-19 vaccines have been administered in the United States, and health authorities say boosters could become as common as the annual flu shot, it remains the only way people harmed by the shot can receive compensation. 

It's far from guaranteed they’ll get it. 

Before the pandemic, this program received a little over 500 claims and had paid out compensation to only 30 people – mostly for H1N1 (swine flu) vaccine injuries. In just the past two years, it has been asked to make decisions on over 10,000 injury claims related to COVID countermeasures.  

As of June, it made decisions on just 919 of these COVID-related claims and rejected 894 of them. It has so far paid out only $8,593 in compensation to just four people who were injured by a COVID vaccine. The program has deemed another 20 people eligible for compensation, but has yet to pay them.  

It’s not a judicial process either. Rather, it’s an administrative process overseen by Health Resources and Services Administration, which is housed within Department of Health and Human Services (HHS). People file a claim and government medical reviewers decide whether to pay out or not. That’s an awkward arrangement, given that HHS is deciding whether to pay for damages caused by products it approved and in some cases mandated.  

Because it’s an administrative process, there’s no right to counsel and no neutral arbitrator. A denied claimant can file for reconsideration with HRSA, but otherwise has no right to appeal. 

Unlike the earlier program, the CICP offers no compensation for pain and suffering and doesn’t pay attorneys’ fees. Most successful claimants have received compensation totaling a few hundred dollars or a few thousand dollars. The highest award for a COVID-19 vaccine injury sufferer was $3,957.66 to a person who got myocarditis (a heart condition) from a vaccine.  

It also has shorter filing deadlines. People have to file a claim within one year of vaccination, a much shorter window than the earlier program’s standard of three years from the onset of symptoms. Of the 894 claims that CICP has rejected, 444 of them were for missing the filing deadline.  

CICP also only awards compensation in cases where there’s “compelling, reliable, valid, medical, and scientific evidence” that someone’s injury is linked to a covered countermeasure. HRSA describes this as “a high evidentiary standard.” Renée Gentry, a practicing vaccine injury lawyer who directs the Vaccine Injury Litigation Clinic at George Washington University, says it’s a much higher bar than what the earlier vaccine injury compensation program requires, which contributes to a much lower rate of successful claims.  

The Countermeasures Injury Compensation Program’s nature as a small emergency program has seen its capacity strained by a flood of COVID-related injury claims. Of the 11,806 COVID-related claims filed, 10,887 are still pending. Those four cases where COVID compensation was paid out didn’t come until after April 2023, over two years since the first vaccines were administered.    

Pain and Suffering  

The shortcomings of CICP are all too apparent for the people who are forced to wade through it. Even folks who seem to have done everything right are left waiting or disappointed by the program.  

Fox filed her claim in May 2021, which was relatively early in the immunization campaign. She also had clear diagnoses from well-credentialed doctors linking her conditions to her COVID-19 vaccination. Fox says she provided the program with no shortage of documentation as well. 

After filing all that paperwork, she hasn’t been idle either. After months of not hearing anything back from CICP, Fox started to reach out repeatedly to anyone she thought might be able to move the needle. She spoke repeatedly with representatives from Sen. Jeanne Shaheen’s and Rep. Chris Pappas’ offices. She also kept calling program administrators, trying to figure out what was taking so long.  

“I’m sure they saw my number, and said ‘Ah, Fox, oh no, not her [again]’,” she jokes.  

Her congressional representatives did reach out to CICP on her behalf. That was at least effective at getting program administrators to call Fox personally twice, once in July 2022 and again in June 2023. But each time, they could only offer her reassurance that her paperwork had been received. On both calls, Fox says she was told that the program was vastly overburdened by the flood of COVID-19 claims it had received. She, like thousands of others, would have to wait.  

The few decisions on COVID-19 claims that have trickled out haven’t offered much relief to the people who’ve received them. That includes Cody Flint, one of the 894 people who’ve had their COVID-related claims rejected.  

Flint was vaccinated in February 2021, when he received a single Pfizer dose. He says that he started to feel headaches and had affected vision within 30 minutes of the shot. He was still experiencing symptoms two days later when he headed to his job as a crop-dusting pilot.  

While flying that day, he started to experience extreme tunnel vision, followed by a sensation he describes as “a bomb [going] off in my head.” He barely managed to get his plane back to his runway, where his coworkers found him slumped over his controls and shaking. 

He was diagnosed with perilymphatic fistula (or tear of the inner ear) caused by elevated intracranial pressure – which could only be relieved through repeated draining of his spinal fluid. Given the timing of his symptoms and the fact that he’d passed a flight physical just a couple weeks prior, his doctors said his condition was almost certainly caused by the vaccine. His injury prevented him from returning to work as a pilot, and his mounting medical bills saw him draw down all of his savings.  

In April 2021, Flint filed a claim. In May 2022 – just a few weeks after Sen. Cindy Hyde-Smith asked HHS Secretary Xavier Becerra about his case specifically in a committee hearing – Flint’s claim was rejected. The program’s medical reviewers told Flint that it was more likely his injuries were caused by barotrauma from flying a plane.  

He petitioned for a reconsideration of his case. His doctors argued that there was no way he’d have experienced barotrauma from flying just a few hundred feet off the ground. Commercial airliners, they noted, are pressurized at 6,000 to 8,000 feet of elevation. Flint’s lawyers also submitted recent studies linking the symptoms he’d experienced to COVID-19 vaccinations.  

Nevertheless, a separate medical reviewer at HRSA upheld the CICP’s initial denial in January 2023. That letter succinctly stated that HHS has “no appeals process beyond this reconsideration” and “there is no judicial review of a final action concerning CICP eligibility.”  

Efforts at Reform  

The federal government’s liability protections for COVID-19 vaccines aren’t scheduled to expire until the end of 2024. Once they do, those claiming a vaccine injury will be able to pursue claims against vaccine manufacturers in state courts.  

While liability protections remain in effect, the federal program is injured claimants’ only potential source of compensation.  

Whether or not the HRSA succeeds in boosting staffing in line with its statement to RCI, those seeking compensation have started to get organized. They’ve formed the group React19, which is dedicated to advocating for additional research into the side effects of COVID-19 vaccines. It’s grown into a network of tens of thousands of people who say they suffered adverse injuries from the shot. Flint, the pilot, is on its board of directors.  

“It’s a very pro-vaccine community,” says Christopher Dreisbach, the group’s legal affairs director. “You say anything about vaccine injuries, you’re branded as anti-vaxxers. We are pro-science, we are not political. We’re just dealing with a very politicized issue.”  

He says the politicization of vaccines has made their efforts at compensation reform a challenge.  

When the CICP, and the 2005 Pandemic Response and Emergency Preparedness (PREP) Act that created it, were first being debated, Republican lawmakers were its main advocates, while its main critics were Democrats. The partisan politics of the program and liability protections for pharmaceutical companies has done a 180 since COVID.  

In 2005, Rep. Sheila Jackson Lee argued during the House floor debate on the PREP Act that the law’s liability shield would leave injured healthcare workers with little protection or chance of compensation. Come 2023, she would return to the floor of the House to argue in favor of mandating those same healthcare workers receive a vaccine covered by the PREP Act’s liability shield.   

The PREP Act’s harshest critics during COVID, meanwhile, have mostly been Republicans.  

“I call the PREP Act medical malpractice martial law,” says Rep. Thomas Massie, who complains that its liability shield is both incredibly broad and improperly preempts state law. “I think it’s sort of anathema to the way our government is set up. I found it hard to believe that Congress would pass something, much less that a Republican president would invoke it.”

In March 2022, Sen. Mike Lee introduced a bill that would have amended CICP to give claimants the same framework for pursuing compensation as the VICP. They could file in Federal Claims Court and receive an expedited, judicial adjudication of their injury claim.  

Gentry argues that it would be far simpler to just move the COVID-19 vaccines into the VICP program, which already has a successful track record of adjudicating injury claims. In order for that to happen under the law that created the VICP, the CDC needs to recommend the vaccines for routine administration to children (which has already happened) and vaccine manufacturers would have to start paying excise taxes. That latter condition will require action from Congress.   

VICP needs a number of updates as well, says Gentry, including expanding the number of special masters to handle the backlog of cases and increasing the available levels of compensation (which haven’t been updated since the 1980s).  

Increasing the number of special masters is particularly important if the VICP program is going to be expected to process tens of thousands of COVID claims, she says. But she argues it’s the best way of getting the vaccine injured out of CICP and into a program that will work for them. “If you’re taking away someone’s constitutional right to sue, you really have to give them a reasonable and meaningful alternative and that’s what this program is, for all of its faults,” says Gentry.  

While efforts at reform in Washington lumber on, React19 has started a privately funded compensation program that’s thus far paid out $552,000.  

“Is that making a meaningful difference to all the vaccine injured everywhere? No, that’s not enough,” says Dreisbach, but he notes that it’s far more than what CICP has paid out. “That should be pretty embarrassing to the federal government.”   

This article was originally published by RealClearInvestigations and made available via RealClearWire.

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