While most people who are protected with a coronavirus vaccine will never develop serious side effects, these rare cases are banned in federal court and instead go to an obscure program with a history of rarely that they pay claims.
The Countermeasure Injury Compensation Program, which was created specifically to treat vaccines under emergency authorization, has only four employees and few distinctive features of an ordinary court. Government officials make decisions in secret, claimants cannot appeal to a judge, and payments in most death cases are limited to $ 370,376.
This contrasts with the much more established federal vaccine court, which decides cases of injuries from most childhood vaccines and other routine inoculations.
George Washington University law professor Peter Meyers has been following the countermeasures program for years and bluntly calls it a “black hole,” obtaining federal documents this summer that show he has paid less than 1 in each. 10 claims in its 15-year history.
Historically, vaccines offer extensive protection with little risk, but they do have occasional side effects just like any other drug. Massive coronavirus vaccine trials involving tens of thousands of participants have so far shown no signs of serious side effects and few unexpected adverse reactions have been reported during the first days of COVID-19 vaccine distribution in the United States. USA.
But experts are concerned that with the large volume of people expected to receive coronavirus vaccines in the United States (more than 200 million), even with a successful deployment with relatively few negative effects may be enough to flood the program. In addition, these cases are complex and it is often difficult to demonstrate a direct link between disease claims and a vaccine.
“It should be safely increased,” said Dr. Vito Caserta, who oversaw the countermeasures program from its inception until its retirement in 2014. “They may feel overwhelmed very, very quickly.”
Asked about this possibility, David Bowman, a spokesman for the Health Resources and Services Administration that oversees the program, said he “plans to process the potential influx of COVID-19 claims. … Additional staff and contractors will be hired as needed. “
The program of countermeasures was created by a 2005 law to allow pharmaceutical companies and government entities the freedom to develop and distribute vaccines to meet urgent public health needs without the threat of being invaded by costly lawsuits. of civil liability. According to the program, drug manufacturers can only be sued for “intentional misconduct.”
Several senators opposed at the time, with the late Massachusetts Democrat Edward M. Kennedy saying it was a “Christmas present for the pharmaceutical industry and a bag of charcoal for everyday Americans.”
The vast majority of program claims come from the H1N1 swine flu vaccine a decade ago. And the low number of people awarded money (29 out of 499) reflects its design.
Most claims must be filed within one year of the vaccination, regardless of when the side effects occur, and the program does not pay fees for lawyers or experts. It provides few opportunities for claims to participate. And rewards don’t pay for suffering or harm.
On the contrary, the vaccine court allows claims within three years, pays lawyers and witnesses, grants sentences for pain and suffering, and allows appeals to the Supreme Court.
The difference is reflected not only in the number of awards, but in their size. The countermeasures program has paid $ 6 million, for an average prize of about $ 200,000 per claim. The vaccine tribunal has not only paid in 7 out of 10 cases in recent years, but its average per claim ($ 570,000) is more than two and a half times higher, with a total of $ 4.4 billion in its three-decade history.
Law professor Meyers, who obtained the data on the compensation court through a request from the Freedom of Information Act, called the 29 awards so far “surprisingly low” and called for a review of the program.
He also expressed concern that it could deter people from getting vaccinated amid a pandemic that has so far infected more than 75 million and killed nearly 1.7 million people worldwide.
“It’s a great argument for anti-vassals to say,‘ Oh my God, that’s dangerous, and if something happens to you, the program will turn its back on you, ’” said Meyers, a former chairman of a government advisory group vaccine court.
Meyers said it would be helpful to know specifically why each claim was approved or rejected in the compensation program, but did not publish even the most basic details, such as the type of illnesses people claim to get from vaccines.
Sarasota, Florida vaccine attorney Anne Carrion Toale believes one of the most important reasons for the rejection is the one-year deadline to file it. He recalled receiving dozens of calls from people saying they had been sick with H1N1 vaccines a decade ago, some complaining of possible symptoms of Guillain-Barre syndrome, a rare immune system disorder that can lead to paralysis or death. .
“They arrived too late,” he said. “There was nothing we could do.”
No one is sure how many of the more than 200 million Americans who are expected to receive coronavirus vaccines are likely to develop serious side effects, and not everyone who does will file a claim. Only one in a million people who received the measles, mumps, and rubella vaccines first administered half a century ago suffered severe reactions, but other vaccines had higher rates.
The use of 25 per million that suffered serious side effects from the H1N1 vaccine, for example, would make the number of such cases of coronavirus vaccines more than 5,000. This is more than ten times what the countermeasures program has received in its entire history.
Meyers said one solution is to take coronavirus claims to a vaccine court, formally known as the National Vaccine Injury Compensation Program, but that same court is trying to resolve its own cases, and its eight judges are bringing more five years to resolve claims.
Vaccines covered by the countermeasures program can go to a regular immunization court once they are recommended by federal regulators for “routine” administration, specifically to children or pregnant women. But Meyers said that would not happen soon.
Another problem is funding. Unlike court claims against vaccines, which are funded with a special tax of 75 cents for each vaccine, the countermeasures program depends on Congress for its budget. A $ 30 billion Congressional allocation to buy vaccines and fund other efforts to fight the coronavirus allows part of that money to be transferred to a fund to pay for claims, but none has yet been transferred.
HRSA spokesman Bowman said such requests will be made as the need for funding arises.
The aforementioned Justice Department vaccine lawyer Richard Topping, now legal director of health insurer CareSource, said it is not good enough.
“We essentially have no plan, no coverage,” he said.
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Condon reported from New York, Sedensky of Philadelphia.