High school student Emma Burkey received her “one and done” Johnson & Johnson coronavirus vaccine on March 20 and was in an induced coma within two weeks of seizures and clotting in her brain.
She is slowly recovering, having recently been transferred from hospital to a rehabilitation center, and the first round of bills totaled $ 513,000. The 18-year-old's family friends in the Las Vegas area started a GoFundMe account to help with medical costs of the very rare vaccine reaction.
"We don't know what's going to happen to Emma, how long it will take for her to return to a normal life," said Bret Johnson, the family secretary who acts as spokesman for the Burkeys. He said the family believes her condition is related to the vaccine, but has not yet been contacted by the company or the U.S. health authorities, and a link has not been independently confirmed.
Burkey & # 39; s family can't look to J&J to cover medical expenses not covered by her insurance because a 2005 law – extended last year to include the Covid-19 pandemic – shields manufacturers and health care providers of state and federal liability in cases of public health and bioterrorism emergencies. In exchange for immunity to vaccine makers, the federal government has pledged compensation for side effects from coronavirus treatments and vaccines, but it's a program with a history of denying claims and a relatively high cost recovery bar.
The Countermeasures Injury Compensation Program, operated by an unknown office within the U.S. Health and Human Services Department, covers medical expenses and lost wages not covered by insurance. According to the Health Resources and Services Administration, which administers the program, 445 claims had been made for Covid-related side effects as of April 26.
The Centers for Disease Control and Prevention said in a statement that the vaccines had been "thoroughly studied" before they were approved, and "are being tightly controlled now that they are used by the public." From more than 240 million vaccines from three manufacturers that have been managed in the US, the CDC said there are currently no confirmed deaths from vaccines and reports of allergic reactions are consistent with those from vaccines for other conditions.
More than 8.1 million people have received the J&J injection, and so far 17 – including Burkey, her pastor said – have reported a rare form of blood clotting. Burkey's case was being considered by health officials during a break in distribution of the J&J recording, Johnson said. US regulators said the vaccine is safe and effectiveand continue to investigate whether there is a link between the injection and the rare blood clot syndrome.
J & J's media department did not respond to an email requesting comment. With regard to 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 detected early and treated effectively."
According to HRSA, only about a quarter of the Covid-related responses reported in the countermeasures program so far have come from vaccines, while more than half have come from different treatments. Those treatments included ventilators, restorative plasma, and hydroxychloroquine – the anti-malarial drug touted by former President Donald Trump that was found to have greater risks than benefits in treating coronavirus.
According to allegations, 50 people were killed as a result of alleged failure to provide adequate care. Claims of this kind would normally result in civil lawsuits, but under the law protecting vaccine makers and health professionals, lawsuits can only proceed if there is "willful negligence", a high bar in US courts.
The reimbursement claims also include reports of death from ventilator use and other treatments, and a wide variety of health problems after vaccination, including chest pain, facial cramps, paralysis, and even injuries such as broken ankles. It will take some time for researchers to determine whether there is 'convincing' there is scientific evidence to link those injuries to the vaccines or treatments.
There have been no payouts in Covid cases so far, which the HRSA says is because it has not received all the necessary information. The required medical records have still not been received from the applicant in the first claim, which was filed in September due to an adverse reaction to restorative plasma, the agency said.
Critics say the countermeasures program is not the best way to deal with the vaccine claims. The program has been around for a decade and, as of April 1, on its own found it 39 of the nearly 500 claims were eligible for compensation – mostly for reactions to the H1N1 vaccine – and only paid about $ 6 million in 29 cases.
Instead, they say that compensation claims must go through a decades-old program within the same body called the Vimmunity, also known as the "vaccine court". It has a special source of funding – an excise duty on any vaccine administered in the US – but limited to those shots routinely recommended for children and pregnant women, and those for the seasonal flu.
Anne Carrión Toale of Maglio Christopher & Toale in Sarasota, Florida, former president of the Vaccine Injured Petitioner & # 39; s Bar Association, said her office was & # 39; overwhelmed & # 39; is through phone calls from people trying to find out if different medical conditions are caused by the vaccines and or each story.
"Especially with the Covid vaccine, a higher percentage of phone calls are reassuring and 'I have questions' than with a normal vaccine," said Toale. She hopes Congress will move the Covid vaccine cases to vaccine court, where the odds are. payout is greater and it also pays for & # 39; pain and suffering & # 39; and covers legal costs and expert witnesses.
A HRSA spokesperson said that in order for injuries from Covid vaccines to be covered by the vaccine court, they must 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.
The US government's vaccine compensation program has its roots in the proliferation of lawsuits. Vaccines are intended to stimulate the immune system to fight disease. In rare cases, they can cause the system to hyperdrive, which can lead 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 included an obligation to cover side effects, and established the vaccine court.
A ordinance to rule out compensation for serious shoulder injuries and fainting – which makes up the bulk of the claims – was repealed by the Biden administration and Congress is considering doubling the number of special masters handling cases.
When that happens, all countermeasures should be brought to the vaccine court, including those not involving vaccines, said Peter Meyers, former director of George Washington University Law School's Vaccine Injury Clinic.
"It can be a tough scientific question," said Meyers, referring to whether there is a link between a side effect and a treatment. “We will never, like the norm in the criminal court, have evidence beyond a reasonable doubt. It may be a complicated question, but it is a doable question.”
The vaccine court has a list of side effects that are known to be sometimes caused by a vaccine, making it easier for an application to get reimbursed without showing a direct link. It also has a lower burden of proof, requiring only that the vaccine is likely to be the cause.
Emma Burkey, who works with children and does a part-time gig at a construction company, decided to get the coronavirus vaccine, even though she wasn't in a high-risk group.
About a week later she started to feel unwell and 10 days after receiving the injection she went to bed with a headache and vomited. Her parents, Russ and Kathy Burkey, helped her to the bathroom, where "her face locked and head contorted," said Johnson, the family secretary. "They could see in her eyes that something was very, very wrong."
An ambulance took Burkey to the local hospital in southern Nevada, where doctors realized her responses were similar to those of others reported in the J&J admission. Emma was flown to a neural treatment unit at Loma Linda Hospital in San Bernardino, California.
The family expects most of the costs to be covered by insurance. They learned about the compensation program during a phone call from the office of US Senator Catherine Cortez Masto. Nevada Democrat staff have also contacted HHS and will follow up on Burkey's case "to make sure the family is getting the support they deserve."
If the initial bill to the Burkeys is any indication, the cost of Emma & # 39; s medical care could run into the millions of dollars. Her insurance company has already agreed to cover the long-term rehab she needs, Johnson said in an update on the GoFundMe page, which has raised about $ 48,000 to date.
"Right now it feels like the national debt," Johnson said. "It's so big you can't ignore it."
Copyright 2021 Bloomberg.