Government program tapped to pay for COVID-19 vaccine injuries rarely sides with consumers
In March, Minister of Health and Human Services Alex Azar stated that all claims for damages based on COVID-19 vaccines would be handled under a program run by his agency.
Because the vaccine is a one-off virus that isn't approved for routine use, anyone seeking compensation for a serious side effect is referred to a little-known federal program that is rarely on the consumer side.
That program, the Countermeasures Injury Compensation Program, has denied 90% of vaccination injury claims over the past decade.
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In contrast, the federal government's "vaccination tribunal", which handles claims primarily related to routine vaccines for children, paid about 70% of claims from 2006 to 2018.
While COVID-19 vaccines are being shipped to millions of Americans, some attorneys and consumer advocates are wondering if people are getting a fair rating in the rare cases of alleged harm.
"We will have hundreds of millions of people receiving the COVID vaccine," said David Carney, a Philadelphia attorney who deals with vaccination violations. "The available recourse when and likely when people experience side effects will be quite limited."
Consider the following: How to convince someone to take the COVID-19 vaccine
Even with safe vaccines, serious side effects can occur
With more than 325,000 COVID-19 deaths in the U.S. and as hospitals struggle to cope with the winter flood of patients, public health experts say vaccines will play a vital role in slowing the pandemic.
The federal government has issued emergency approval for two vaccines that are safe and effective. Two more could be approved by February.
Clinical studies involving tens of thousands of patients concluded that Pfizer / BioNTech and Moderna vaccines are highly effective, safe, and have minor side effects such as pain, redness, and swelling.
Two COVID-19 vaccines are approved in the US: Here's what we know about them
But when millions of people are injected, say consumer advocates and advocates, even the safest vaccines can cause side effects in a small number of people.
"When a brand new vaccine comes out, you want people to take it," Carney said. "No matter what vaccines are issued, you will always have that rare percentage of people whose immune systems are just raised in the wrong way, revved up the wrong way, and having adverse events."
Six Americans and at least two people in the UK had severe allergic reactions to the Pfizer / BioNTech vaccine, according to the Centers for Disease Control and Prevention. Although the federal government is investigating these reactions, the vaccine appears to be safe for anyone who has not had an allergic reaction to any of its ingredients.
Even if COVID-19 vaccines only cause one claim for every million people who receive a shot, it could significantly add to the workload of the countermeasures program approved by the Federal Preparedness and Emergency Preparedness Act of 2005 to Address Pandemic Threats and Bioterrorism Threats .
The program, run by the Health Resources and Services Administration, has examined an average of fewer than five applications per month since 2010. Four employees are employed.
"It could essentially break the countermeasure program," said Anne Carrión Toale, a Sarasota, Fla., Lawyer whose office has handled hundreds of vaccination violation cases.
The agency plans to hire more staff and contractors to cope with the workload of COVID-19 vaccine claims, a spokesman said.
Since 2010, the countermeasures program has rejected 450 out of 499 claims for damages. It paid 29 claims totaling more than $ 6 million. Ten cases were eligible for compensation but had no cost to pay, and ten cases are currently under investigation.
More: Side effects of the COVID-19 vaccine mean "your body reacted the way it should," experts say
The "vaccination court" usually decides in favor of the patient
Attorneys and consumer advocates say another program that has been shown to have ruled in favor of consumers would be better at handling COVID-19 cases.
The Vaccination Tribunal, officially known as the Vaccination Injury Program, holds hearings before independent "special masters". Their decisions about compensation are public, but they protect patient confidentiality. Consumers have three years to file a lawsuit and the court pays for attorneys and medical opinions.
The vaccination court paid 5,297 out of 7,565 petitions from 2006 to 2018, which corresponds to a rate of 70% in favor of the patients. But cases are still rare. For every 1 million doses of vaccine, one person will be compensated for a claim, according to the Health Resources and Services Administration.
The Moderna COVID-19 vaccine will be administered Monday by an employee at the United Memorial Medical Center in Houston. The hospital, which mainly serves low-income and uninsured patients, did not receive a Pfizer vaccine last week.
However, the program used for the COVID-19 vaccine limits claims to one year after a person receives a vaccine, does not pay legal fees, and does not hold any hearings.
Unlike the vaccination court, the countermeasures program doesn't pay for pain, suffering, and rehabilitation and, according to lawyers, only offers partial compensation for lost income.
Those who have been denied compensation through the countermeasures program have virtually no legal recourse. If they were to sue in civil court, they would have to prove that the drug manufacturers acted in "willful misconduct" - an extremely high standard of law designed to protect those who manufacture, distribute, and administer vaccines and treatments to a deadly public health threat such as COVID-19.
Call to bring COVID-19 vaccine claims to the vaccination court
Peter Meyers, former director of the Vaccine Injury Clinic at George Washington University Law School, said public confidence depends on a fair compensation program for rare side effects. He wants Congress and President-elect Joe Biden's administration to replace the countermeasures program with a new one that borrows items from the Vaccination Court and 9/11 Victims Compensation Fund.
In an essay posted on the Journal of Law and the Biosciences website on Nov. 26, Meyers argues that if the countermeasures program is not improved or replaced, there will "anti-Vaxxern ammunition" and undermine the widespread use of these vaccines ".
So far, American adoption of the coronavirus vaccine appears to be increasing as healthcare workers and nursing home residents receive their first doses. In a recent USA TODAY / Suffolk University survey, 46% said they will start taking the vaccine as soon as possible - almost twice as much as the 26% who said it did in late October. Another 32% are waiting for others to take pictures first.
"Trust is essential here," said Meyers, professor emeritus at George Washington University Law School. "It's very important to get the message across to people: we have a good program to take care of you, if you are one of the very rare people to have a side effect."
Henry Jackson, right, a Lee Health employee in the transportation services division, is one of the first frontline workers for Lee Health to receive the COVID-19 vaccine. The vaccine was given on Tuesday, December 22, 2020 at Lee Health Gulf Coast Medical Center in Fort Myers, Florida. The vaccines are administered by nurse Edson Bezerra. On the left, R.N. Samara Marin. You will be given the Pfizer vaccine.
Program denied claim from teenagers paralyzed after receiving the H1N1 vaccine
In March, Azar invoked the 2005 PREP Act, stating that COVID-19 vaccines and treatments would be covered under the countermeasures program. It handled injury claims for the 2009 H1N1 flu vaccine and rarely used vaccines such as anthrax and smallpox.
Although the government does not publicly release figures on types of claims, a request from Meyers under the Freedom of Information Act found that the agency had rejected 372 of 407 applications for the H1N1 vaccine in 2009. All 18 anthrax vaccine applications and eight out of 11 smallpox vaccine applications were denied.
Robert Beckham of Conowingo, Maryland, was in high school in 2009 when he received the H1N1 vaccine. He was hospitalized about a month later and was eventually diagnosed with transverse myelitis, a neurological disorder that can cause pain, weakness, and paralysis.
Since then he has been paralyzed from the chest down.
His lawyer filed a lawsuit with the vaccination court, but it was included in the countermeasures program. Despite the fact that his attorney produced extensive medical records and his neurologist presented a letter saying the vaccine was most likely the cause, his application was denied. There was no hearing and no opportunity to appeal.
Beckham, 26, from Baltimore County remains in a wheelchair. He was in and out of the hospital with complications.
"I was just trying to make sure I was healthy and safe from the flu and the boom. I basically end up losing my life," Beckham told USA TODAY. "Everything changed in no time."
If his injury had occurred a year later, he could have taken his case to a vaccination court. In 2010, the annual flu vaccine for children and adults was expanded to include the H1N1 vaccine. Routine applications for flu vaccines are dealt with in the vaccination court.
As part of the countermeasures program, individuals claiming vaccine injury are required to provide "convincing, reliable, valid, medical and scientific evidence," said David Bowman, spokesman for the Health Resources and Services Administration.
Because the program doesn't pay for lawyers or medical experts, it's challenging for people to prove cases for themselves, said Toale, the Sarasota attorney who handles vaccination violation claims.
"If a defense, problem, or issue is raised, how will that person have access to medical experts or be able to pay the money?" Toale asked.
This is one of the reasons lawyers and consumer advocates want to take the COVID-19 vaccine to a vaccination court.
It won't happen now, if at all. To be eligible for a vaccination court, the CDC must recommend a vaccine for routine use by children or pregnant women. None of the clinical trials for vaccines included pregnant women, nursing mothers, or children.
With no clinical data, obstetricians and gynecologists say pregnant women should decide whether to get vaccinated, based in part on how far the virus has spread in their community. Doctors and public health experts say the benefits of the vaccine likely outweigh the risks.
Vaccines must also include a nominal excise duty to be eligible for a vaccination court. If a vaccine is routine and taxed, the Secretary for Health and Human Services can challenge it for a vaccination court.
Kim Witczak, a consumer representative on an advisory committee for the Food and Drug Administration, said the widespread use of the coronavirus vaccine means greater protection is needed for people with rare but serious side effects.
"People must be able to be compensated - or at least have a fair trial," said Witczak. "You must have a fair and reasonable process to obtain compensation for any injuries."
Ken Alltucker is on Twitter as @kalltucker or can be emailed to email@example.com
This article originally appeared in the US TODAY: COVID Vaccination Violations Submitted to Program That Denies Most Claims
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