Americans who have adverse reactions to coronavirus vaccines that the US race to develop will have a hard time getting compensation for drug injuries.
This is because pandemic-related claims for faxes will be forwarded to a rarely used federal program set up to encourage drugmakers to help combat cases of public health. It saves pharmaceuticals and device makers from costly liability claims in exchange for taxpayers compensating injured patients – though it does not guarantee there is money to do so.
Since its inception in 2009, the program has disbursed less than $ 6 million, and it has yet to receive any dedicated funding from the U.S. government for Covid-19.
A medical worker draws liquid from a vial with a syringe.
Photographer: Andrey Rudakov / Bloomberg
“At best, this is going to be a big deal,” said Richard Topping, a former attorney general who represented the U.S. in disputes over the debunked link between vaccines and autism in children. “Worst scenario? It will be a crisis. ”
President Donald Trump urges drugmakers to develop a Covid-19 vaccine in record time under an initiative known as Operation Warp Speed, which aims to deliver 300 million doses by January 2021. However, most Americans are unlikely to
The U.S. Food and Drug Administration has said it will not cut corners when it comes to safety tests like companies like
“No vaccine or drug is 100% safe,” said Cody Meissner, head of the Pediatric Infectious Diseases Department at
Congress earlier this year gave the Department of Health and Human Services $ 30 billion to fund the development of coronavirus “countermeasures” – vaccines, treatments and devices used to treat the pandemic. Although the HHS legislation may transfer part of that money to the Countermeasures Injury compensation program, this has not yet happened and it is unclear how much would be needed.
HHS has so far not received any Covid-19 injury claims and the compensation program has not requested funding, according to a senior administration official. Of the $ 30 billion authorized Congress, $ 10 billion has so far been allocated for research and development of vaccines and treatments, the official said.
“When someone is vaccinated, they help not only themselves but society,” he said
Faxes are
The potential volume of people affected “will be too much for some unfunded compensation program,” said Topping, currently chief legal officer of CareSource Management Group Inc., a Dayton, Ohio-based nonprofit that is one of the nation’s largest Medicaid-managed health care plans.
Having compensation treated through the countermeasure program “would be terrible,” said Anne Carrión Toale of Maglio Christopher & Toale, former president of the Bar Association of Vaccine Injured Petitioner’s.
Proponents of her case have been working to make the actual transcript of this statement available online. The bill is based on a decades-old program called the Facsimile Reimbursement Program. It has a dedicated source of funding – an action tax on all administration vaccines – but is limited to those routinely recommended for children and pregnant women and the vaccine for seasonal flu.
The lawsuit was filed in the 1980s when drugmakers threatened to stop vaccinating after lawsuits over side effects of diphtheria, pertussis and tetanus, like DPT, vaccine.
The drugmakers created a safer vaccine – the DTaP – and Congress introduced a no-liability system for manufacturers in exchange for introducing 75 cents from each vaccine antigen to compensate those who had adverse reactions to immunizations for children.
But in the wake of the September 11, 2001 terrorist attacks, Congress created the countermeasure program to accelerate compensation to people injured by drugs, vaccines, and devices developed in response to pandemics and national security events. These included biological warfare and radiation poisoning. One of the vaccines in that category is for anthrax.
“We want to vaccinate people and we do not want to expose pharmaceutical companies to the kind of liability they would otherwise have,” he said.
39 Claims
The countermeasure program has not been widely used – it has paid 39 claims totaling $ 5.7 million since it began in 2009.
In contrast, the vaccine court has paid tens of millions of dollars in single cases to cover lifelong medical costs. Overall, the court, located in the U.S. Court of Federal Claims, has settled 7423 claims since its inception in 1988, totaling $ 4.3 billion, according to the
The countermeasure program places a higher financial burden on people seeking compensation, and does not allow for expert witnesses, hearings or appeals, said Toale, who believes injuries to coronavirus vaccines should be treated through the vaccine court instead. The fax court also pays for victims’ attorneys, while the countermeasure program does not.
Not everyone agrees that the programs benefit victims.
They amount to an “out of jail-free card” for drugmakers, he said
Attempts are being made to prevent potential harm by Covid vaccines, said Martin Kulldorff, a biostatistician and professor at Harvard Medical School who is part of a CDC group that analyzes weekly patient reports.
‘If the first vaccine comes out and it turns out that there is a serious adverse reaction and we did not pick it up until there are millions of doses, that will reduce confidence, not only in a subsequent Covid-19 vaccine, but also faxes in general, ”said Kulldorff.
Eventually, a small fraction of people will ever be harmed by any vaccine, and that probably includes those designed to prevent Covid-19.
“The concern is that if a Covid vaccine becomes available after this enormous investment in money and time, people will not take it,” Meissner said. Providing compensation “will give the guarantee to people who are worried about a negative reaction.”
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