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Rare victims of Covid-19 vaccine and treatment trauma turn to US fund

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High school student Emma Burkey received her Johnson & Johnson ‘one and done’ coronavirus vaccine on March 20, and within two weeks was in an induced coma from seizures and clotting in her brain.

She is slowly recovering, having recently been transferred from the hospital to a rehabilitation center, and the first set of bills was $ 513,000. Family friends of the 18-year-old in the Las Vegas area have opened a GoFundMe account to help cover medical bills related to the very rare vaccine reaction.

“We don’t know what’s going to happen with Emma, ​​how long it will take for her to resume a normal life,” said Bret Johnson, the family minister, who acts as the spokesperson for the Burkeys. He said the family believed his condition was vaccine-related but had not yet been contacted by the company or US health regulators, and that a link had not been independently confirmed.

Of more than 240 million vaccines from three manufacturers that have been administered in the United States, the CDC said there are currently no confirmed vaccine-related deaths and reports of allergic reactions are consistent with those of vaccines. for other conditions.

Burkey’s family can’t turn to J&J to cover medical costs not covered by their insurance because a 2005 law – extended last year to include the Covid-19 pandemic – protects manufacturers and healthcare providers responsibility of the state and federal government in the event of public health and bioterrorism emergencies. In return for immunity from vaccine manufacturers, the federal government has promised compensation for adverse effects from coronavirus treatments and vaccines, but it’s a program with a history of rejection of applications and a relatively high bar for cost recovery.

The Countermeasures Victims Compensation Program, run by an obscure office within the US Department of Health and Human Services, covers medical bills and lost wages not paid by insurance. Some 445 claims had been filed for Covid-related adverse reactions as of April 26, according to the Health Resources and Services Administration, which manages the program.

The Centers for Disease Control and Prevention said in a statement that the vaccines were “rigorously studied” before their approval and are “rigorously controlled now that they are used by the public.” Of more than 240 million vaccines from three manufacturers that have been administered in the United States, the CDC said there are currently no confirmed vaccine-related deaths and reports of allergic reactions are consistent with those of vaccines. for other conditions.

More than 8.1 million people have received the J&J vaccine and so far 17 – including Burkey, his pastor said – have reported a rare type of blood clotting. Burkey’s case was reviewed by health officials during a break in the distribution of the J&J shot, Johnson said. U.S. regulators have said the vaccine is safe and effective and continue to investigate whether there is a link between the shot and rare blood clot syndrome.

Single doses of the Johnson & Johnson Covid-19 vaccine are prepared at a Los Angeles clinic on March 25.

J&J’s media department did not respond to an email requesting comment. Regarding reports of blood clots, the company said on its website that it is working with health regulators around the world “to ensure that this very rare event can be identified early and treated effectively.”

According to HRSA, only about a quarter of the Covid-related reactions reported to the countermeasures program come from vaccines, while more than half have come from various treatments. These treatments include ventilators, convalescent plasma and hydroxychloroquine – the antimalarial drug touted by former President Donald Trump and which presented greater risks than benefits in treating the coronavirus.

“Willful neglect”

50 people were allegedly killed for failure to provide sufficient care. These types of claims would normally result in civil lawsuits, but under the law protecting vaccine manufacturers and healthcare workers, lawsuits can only be brought in cases of “willful negligence,” a bar high in the courts. Americans.

Claims also include reports of deaths from ventilator use and other treatments, as well as a wide range of health problems after vaccination, including chest pain, facial spasms, paralysis and even injuries like broken ankles. It will take time for researchers to determine if there is “convincing” scientific evidence to link these injuries to the vaccines or treatments.

According to HRSA, only about a quarter of the Covid-related reactions reported to the countermeasures program come from vaccines, while more than half have come from various treatments.

There have been no payments so far in the Covid cases, which the HRSA says is due to the fact that he did not receive all the necessary information. The required medical records have still not been received from the plaintiff in the first claim, which was filed in September for an adverse reaction to convalescent plasma, the agency said.

Critics say the countermeasures program is not the best way to process immunization requests. The program has been around for a decade, and as of April 1, only 39 of nearly 500 claims were eligible – mostly for reactions to the H1N1 vaccine – and paid only about $ 6 million in 29 cases.

Instead, they say, compensation claims would have to go through a decades-old program within the same agency called Vimmunity, also known as the “vaccine tribunal.” It has a dedicated funding source – an excise tax on every vaccine administered in the United States – but is limited to vaccines commonly recommended for children and pregnant women, and those against seasonal flu.

Anne Carrión Toale of Maglio Christopher & Toale in Sarasota, Fla., Former president of the Bar Association of petitioner injured by vaccine, said her office was “inundated” with calls from people trying to determine whether various medical conditions were caused by the vaccines and whether there is any recourse to them.

“With the Covid vaccine in particular, a higher percentage of calls are for reassurance and ‘I have questions’ than with a normal vaccine,” Toale said. She hopes Congress will transfer the Covid vaccine cases to the vaccine court, where there is a greater chance of payment and it will also pay for “pain and suffering” and cover legal fees and expert witnesses.

A spokesperson for HRSA said that for injuries from the Covid vaccine to be covered by the vaccine court, they would have to be recommended by the CDC for routine administration to children or pregnant women. “No Covid-19 vaccine currently meets these criteria,” the spokesperson said in an email.

Liability lawsuits

The US government’s vaccine compensation program has its roots in the increase in lawsuits. Vaccines are designed to make the immune system fight off disease. In rare cases, they can cause the system to become enlarged, leading to severe allergic reactions and even paralysis.

In the 1980s, some manufacturers threatened to withdraw from the market due to lawsuits, so Congress ruled that the social benefit of promoting vaccination also meant an obligation to cover side effects and created the Vaccine Court.

If the first Burkeys bill is any indication, the cost of Emma’s medical care can run into the millions of dollars. Her insurance provider has already agreed to cover the long-term rehabilitation she will need.

A settlement to exclude compensation for serious shoulder injuries and fainting spells – which make up the bulk of claims – has been overturned by the Biden administration, and Congress plans to double the number of special masters who hear deals.

If that happens, all cases of countermeasures should be referred to the vaccine court, including those that don’t involve vaccines, said Peter Meyers, former director of the Vaccine Injury Clinic at George Washington University. Law School.

“This can be a difficult scientific question,” said Meyers, referring to whether there is a link between an adverse reaction and treatment. “We will never have, as is the norm in criminal courts, proof beyond a reasonable doubt. This can be a complicated question, but it is a doable question. “

The Vaccine Court has a list of adverse reactions known to be sometimes caused by a vaccine, making it easier for an application to obtain compensation without proving a direct link. It also has a lower burden of proof, requiring only that the vaccine is more likely than not to be the cause.

Emma Burkey, who works with children and works part-time in a construction company, decided to get the coronavirus vaccine even though she was not in a high-risk group.

About a week later, she started to feel unwell, and 10 days after receiving the vaccine, she went to bed with a headache and threw up. Her parents, Russ and Kathy Burkey, helped her go to the bathroom, where “her face got locked in and her head twisted,” said Johnson, the family minister. “They could see in his eyes that something was really wrong.

An ambulance took Burkey to the local hospital in Southern Nevada, where medics realized his reactions were similar to those reported by J&J’s gunshot. Emma was airlifted to a neural treatment unit at Loma Linda Hospital in San Bernardino, California.

The family relies on most of the costs to be covered by insurance. They learned of the compensation program during a call from the office of US Senator Catherine Cortez Masto. Nevada Democratic staff have also reached out to HHS and will monitor Burkey’s case “to make sure the family gets the support they deserve.”

If the first Burkeys bill is any indication, the cost of Emma’s medical care can run into the millions of dollars. Her insurance provider has already agreed to cover the long-term rehabilitation she will need, Johnson said in an update on the GoFundMe page, which has raised around $ 48,000 so far.

“Right now it looks like the national debt,” Johnson said. “It’s so big you can’t figure it out.”

Copyright 2021 Bloomberg.

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