423 million COVID-19 doses administered. 3,100 injury claims filed. $0 paid out.

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Hours after Diane Spears got the single-shot Johnson & Johnson COVID-19 vaccine on March 27, she felt woozy and lethargic, and it only got worse from there.

Gael Brown-Madrigal, 10, receives the first dose of the Pfizer-BioNTech COVID-19 vaccine for children five to 12 years at NYC Health + Hospitals Harlem Hospital, Thursday, Nov. 4, 2021, in New York.© Jeenah Moon, AP Gael Brown-Madrigal, 10, receives the first dose of the Pfizer-BioNTech COVID-19 vaccine for children five to 12 years at NYC Health + Hospitals Harlem Hospital, Thursday, Nov. 4, 2021, in New York.
Doctors at two hospitals diagnosed the Oxford, Pennsylvania, woman with a blood-clot-induced stroke, but it was too late. She died on April 6.

Spears, 68, had never had a stroke and didn't have a known heart condition. Her husband, James Spears, suspects his wife is among the very rare cases of people who developed blood clots and suffered a stroke after getting the J&J vaccine.

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The Food and Drug Administration and the Centers for Disease Control and Prevention paused the J&J vaccine in April after reports of adverse events before deciding the benefits outweighed the risks of keeping it off the market. Of more than 15.5 million doses of the vaccine administered as of Oct. 27, the FDA and CDC identified 48 cases of people who developed blood clots and low platelet counts, a condition called thrombosis with thrombocytopenia syndrome.

Several studies have shown vaccines are safe and effective and serious side effects are uncommon. Of the more than 423 million doses of COVID-19 vaccines in the United States administered through Nov. 1, reports of death remain extremely rare, just .0022% of doses administered. And those reports collected through a joint CDC-FDA reporting database, called Vaccine Adverse Event Reporting System, don't necessarily mean that a vaccine caused the death.

In July, after Diane Spears' death, an attorney representing her family submitted a claim to an obscure federal program that compensates people for serious side effects from vaccines, drugs and other treatments. People who claim injury under the program face an uphill battle getting a favorable decision.

Even before COVID-19 vaccines became common in the USA, the federal Countermeasures Injury Compensation Program rejected more than 90% of nearly 500 claims. Since then, the Health Resources and Services Administration-run program has experienced a fivefold increase in claims related to COVID-19 vaccines and treatments.

Spears’ case is among 3,158 claims alleging injuries from COVID-19 interventions since the beginning of the pandemic. Of those claims, 1,357 allege injuries or deaths from COVID-19 vaccine.

None of those claims has been paid, and only two vaccine cases have been rejected. One rejected claim alleged the vaccine caused swelling of the tongue and throat, difficulty speaking, swallowing and dizziness. The other alleged the vaccine caused a sustained shoulder injury.

Just one COVID-19 claim has been deemed eligible for compensation, but HRSA staff is reviewing allowable expenses. That leaves more than 3,000 cases still under review, a pace that frustrates people such as James Spears who want answers.

He knows his claim won't bring his wife back, and he's not even sure if it would cover the final cost of hospital, medical helicopter and other bills after insurance kicks in. But the pace of the agency’s decision-making underscores the pain and anguish.

"As far as being compensated, that's fine, but it really doesn't replace her," Spears said. “How much can you put on a life? As far as I’m concerned, there’s no real compensation they can give me.”

Background: Government program tapped to pay for COVID-19 vaccine injuries rarely sides with consumers

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FDA committee OKs Pfizer's COVID-19 vaccine for children 5-11
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'Not confident that anything is being done'
Despite the backlog of COVID-19 claims, HRSA has assigned a staff of just five employees and six contractors to conduct medical reviews.

Individuals or their representatives submit claims, then are asked to provide medical records and other documents to support them. The agency often must wait for medical records to process the claims, "the most significant factor" in the timely processing of claims, said Christy Choi, an HRSA spokeswoman.

"We work to process claims as expeditiously as possible," Choi said in an email. "About 90% of claims are awaiting medical records for review."

The countermeasures program requires a high standard of proof for people seeking compensation. It's not enough that someone develops an injury after getting vaccine or treatment. The injured person or the family must provide evidence that the injury was directly caused by a vaccine or treatment.

Since 2010, the program has paid 29 claims totaling more than $6 million. Ten cases were eligible for compensation but had no expenses to pay.

Families who have filed claims and attorneys who represent them say the program does not provide timely compensation or responses.

David Carney, a Philadelphia attorney who represents people claiming injury from COVID-19 vaccines and other vaccines, didn’t anticipate such a large number of pending claims nearly one year after the new vaccines became available.

“I’m not confident that anything is being done with respect to COVID vaccine injuries in the countermeasures program,” Carney said. “I didn’t think this would be the case when we got to November 2021. But now this is the nightmare that’s coming down.”

Carney and others said it's vital to have a fair arbiter of rare injuries because vaccine mandates are becoming more common. The Biden administration announced last week that workers at larger companies must get vaccinated by Jan. 4 or be routinely tested for the coronavirus. About 17 million health care workers at hospitals, nursing homes and other clinics have been required to get the shot or employers could be fined or sanctioned. As a result, some health care employers have fired or suspended vaccine holdouts.

Now that vaccine is being rolled out to kids ages 5 to 11, some said it’s more important than ever to ensure a functional program that compensates rare but legitimate vaccine injuries.

"One of the key parts of having a strong universal immunization program where people have trust in it is having a vibrant safety net under it," said Renée Gentry, director of the Vaccine Injury Litigation Clinic at George Washington University Law School.

Most routine vaccine injury claims are handled through the Vaccine Injury Compensation Program, also known as vaccine court, which conducts hearings before independent "special masters." Consumers have three years to file a claim, and the court pays for attorneys' fees and expert medical opinions.

At the beginning of the COVID-19 pandemic in March 2020, then-Health and Human Services Secretary Alex Azar invoked a 2005 law and declared COVID-19 vaccines and treatments would be handled by the countermeasures program. Up to that point, the countermeasures program mainly handled injury claims for the 2009 H1N1 flu vaccine and other rarely used vaccines against anthrax and smallpox.

Unlike vaccine court, the countermeasures program does not pay attorneys' fees, doesn't compensate for pain and suffering and limits claims to one year after a vaccine or other treatment.

"Countermeasures is a terrible program, but it's the only thing they have right now," Gentry said.

To be eligible for vaccine court, the CDC must recommend a vaccine for routine use by children or pregnant people. The vaccine must be assessed a 75-cent tax per dose, which pays for a trust fund for vaccine injuries.

The Pfizer-BioNTech has the broadest authorization among the three major vaccines. It has received FDA approval for use in adults and emergency use authorization for children ages 12 to 16. A child-sized dose of the vaccine recently was allowed for emergency use for children ages 5 to 11.

The CDC also recommends COVID-19 vaccines during pregnancy, but less than one-third of pregnant people had been vaccinated by mid-September.

Congress, however, has yet to approve a tax on any of the COVID-19 vaccines. And it's unknown how the government would tax a vaccine given that the federal government pays for all COVID-19 vaccine doses.

Bipartisan bills introduced by U.S. Reps. Lloyd Doggett, D-Texas; Fred Upton, R-Mich.; and Mike Kelly, R-Pa., seek to reduce a backlog of cases in vaccine court and allow the HHS secretary to add COVID-19 vaccines to other routine immunizations taxed and in vaccine court. The bills have not advanced in Congress as legislators grapple with big-ticket items. Last week, the House passed a $1.2 trillion infrastructure bill, and lawmakers are debating the Biden administration's $1.85 trillion Build Back Better budget bill.

"Every time something big comes through, this gets kicked to the sidelines," Gentry said of the vaccine legislation. Such delays are "unfortunate because even though it's a tiny program, it's critically important."

Ken Alltucker is on Twitter at @kalltucker, or can be emailed at alltuck@usatoday.com

This article originally appeared on USA TODAY: 423 million COVID-19 doses administered. 3,100 injury claims filed. $0 paid out.

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