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Victims of rare vaccine injuries are waiting to see if the United States will pay



Prom Emma Burkey gets her “one and all” Johnson & Johnson coronavirus vaccine on March 20 and within two weeks was in an induced coma after seizures and clotting in the brain.

She is recovering slowly after she was recently transferred from the hospital to a rehabilitation center, and the first round of bills amounted to $ 513,000. The family friends of the 18-year-old in the Las Vegas area have begun GoFundMe account to help with the medical costs of a very rare vaccine reaction.

“We don’t know what will happen to Emma, ​​how long it will take to get back to normal,”

; said Brett Johnson, the family’s minister who acts as Burke’s spokesman. He said the family believed her condition was linked to the vaccine, but had not yet been linked by the company or US health regulators, and that the link had not been confirmed independently.

Burke’s family could not turn to J&J to cover medical expenses not covered by her insurance, as a 2005 law – expanded last year to include the Covid-19 pandemic – protects healthcare manufacturers and providers from state and federal liability in the event of public health and bioterrorism emergencies. In exchange for immunity for vaccine manufacturers, the federal government promised compensation for side effects during treatment with coronavirus and vaccines, but this is a program with a history of rejection of claims and a relatively high bar for reimbursement.

The Counter-Damage Compensation Program, run by an obscure office within the U.S. Department of Health and Human Services, covers medical expenses and missed salaries not paid by insurance. As of April 26, about 445 claims had been filed for side effects with either vaccines or treatments, according to the Health Resources and Services Administration, which runs the program.

Related: J&J Vaccine responsibility protects against well-being despite rare blood clots

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

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

Johnson & Johnson GETTY sub

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

Photographer: Mario Tama / Getty Images

J&J said it would “carefully review the adverse event reports of people receiving our medicines or vaccines”, but would not discuss individual cases for reasons of confidentiality. Adverse reactions have been reported to the Food and Drug Administration and “we encourage patients to share their experiences, as this information is crucial to maintaining a high standard of product safety,” the company said.

Only about a quarter of the 445 Covid-related reactions reported so far in the response program are from vaccines, while more than half are from various treatments, according to HRSA. These treatments include ventilators, convalescent plasma, and hydroxychloroquine, the antimalarial drug advertised by former President Donald Trump that has been found to have greater risks than benefits in treating coronavirus.

“Intentional negligence”

There were reportedly 50 deaths from alleged lack of care. These types of lawsuits usually lead to civil lawsuits, but under the law protecting vaccine manufacturers and healthcare workers, lawsuits can only continue if there is “intentional negligence,” highly prevalent in U.S. courts.

Claims for compensation also include reports of death after ventilator use and other treatments, as well as a wide range of health problems after vaccination, including chest pain, facial cramps, paralysis and even injuries such as ankle fractures. It will take time for researchers to determine whether there is “convincing” scientific evidence to link these injuries to vaccines or treatments.

So far, there have been no payments in the Covid case, which according to HRSA is because it has not received all the necessary information. The required medical records had not yet been received by the complainant in the first claim, which was filed in September due to an adverse reaction to the convalescent plasma, the agency said.

Critics say the countermeasures program is not the best way to deal with vaccines. The program has been in existence for a decade and as of April 1 only found 39 of the nearly 500 eligible claims – mostly for reactions to the H1N1 vaccine – and paid only about $ 6 million in 29 cases.

Read more: Rush virus vaccine leaves little help for anyone who harms

Instead, they say, claims for compensation must go through a program for decades within the same agency, called the Vaccine Harm Compensation Program, also known as the “vaccine court.” It has a special source of funding – excise duty on each vaccine administered in the United States, but is limited to those shots that are usually recommended for children and pregnant women, and those for seasonal flu.

Anne Carion Toale of Maglio Christopher & Toale in Sarasota, Florida, a former president of the Vaccine Injured Bar Association, said her office was “overwhelmed” by calls from people trying to find out if vaccines cause different medical conditions and any recourse.

“In particular, with the Covid vaccine, a higher percentage of calls are assured and” I have questions “than with a normal vaccine,” Toale said. She hopes Congress will move Covid vaccine cases to the vaccine court, where there is a better chance of payment, and also pay for “pain and suffering” and cover legal fees and expert witnesses.

An HRSA spokesman said that in order for Covid vaccine injuries to be covered by the vaccine court, they should be recommended by the CDC for routine use in children or pregnant women. “No Covid-19 vaccine currently meets these criteria,” the spokesman said in an email.

Liability claims

The U.S. government’s vaccine compensation program is rooted in an increase in lawsuits. Vaccines are designed to activate the immune system in the fight against disease. In rare cases, they can cause the system to go into hyperdrive, leading to severe allergic reactions and even paralysis.

In the 1980s, some manufacturers threatened to withdraw from the market due to lawsuits, so Congress decided that the social benefit of promoting vaccination also meant an obligation to cover for side effects, and set up a vaccine court.

A Trump-era regulation to exclude compensation for severe shoulder injuries and seizures – which make up the majority of claims – was withdrawn from the Biden administration, and Congress is considering doubling the number of special masters handling cases.

If that happens, all countermeasures should be transferred to the vaccine court, including those that do not involve vaccines, he said. Peter Myers, former director of the Vaccine Injury Clinic at George Washington University.

Connected: BidenHHS repeals Trump-Era vaccine compensation rule

“This can be a difficult scientific question,” Myers said, considering whether there is a link between an adverse reaction and treatment. “We will never have, as is the standard in the criminal court, evidence beyond a reasonable doubt. This may be a complex issue, but it is a workable issue. “

The vaccine court has a list of side effects that are known to sometimes be caused by a vaccine, which makes it easier for an application to receive compensation without proving a direct link. It also has a lower burden of proof, requiring only that the vaccine be more likely than not the cause.


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