A U.S. government program which compensates people who say they have been harmed by an emergency vaccine has paid out on over 10 percent of claims, raising questions whether the process ought to be used to tackle any potential side effects from a coronavirus shot, according to some attorneys who have filed such claims.
The attorneys say the app is insufficient for fixing fast-tracked coronavirus vaccines bit.ly/bigpicturecovid.
They say that any COVID-19 vaccine injuries should be handled through another HHS program called the"vaccine court," a transparent process with a much better record of compensating individuals for the infrequent injuries or serious side effects from regular inoculations, such as measles shots.
In regards to addressing any potential injury in the COVID-19 vaccine,"you will find major deficiencies that need to change" in the U.S. approach, stated Peter Meyers, an emeritus professor at George Washington University School of Law and former director of the Vaccine Injury Litigation Clinic.
Meyers described the CICP as a"black hole" process handled entirely within HHS, rather than a courtroom, without fees for attorneys or expert witnesses, a brief one-year window to file claims and restricted participation by the claimant.
HHS declined comment on criticisms of using CICP to process potential COVID-19 claims.
The effort has raised concerns among many Americans that a vaccine may be introduced to tens of thousands of millions of individuals before the prospective risks are fully known.
The U.S. system shifts liability for vaccines to the government, and shields drugmakers, since widespread inoculation against disease is considered a benefit to society.
While billions of vaccine doses have been administered in the USA over the past 30 decades, government data shows that around 1 person in a million suffers a severe injury that warrants reimbursement.
Congress set aside $30 billion annually for HHS to fight COVID-19, such as funding vaccine development and possibly any essential reparation. So far, no claims regarding COVID-19 drugs have been registered with CICP and the program has not asked specific funding, an HHS spokesperson said.
Of 485 claims filed since CICP began reviewing claims in 2010, just 39 people have received reimbursement for a total of $5.7 million, according to the Health Resources & Service Administration (HRSA), which runs the program for HHS.
Almost every one of the claims involved H1N1 pandemic influenza vaccines, based on data obtained by Meyers via a Freedom of Information Act request. The CDC estimates about 123 million individuals over age six months received the vaccine for H1N1, also called swine flu.
"It's not fair to folks on the frontlines, if they are the first to find this vaccine and they have to visit the CICP and get little to nothing," said Renée Gentry, the manager of the Vaccine Injury Litigation Clinic.
U.S. officials have said the first people to get a successful COVID-19 vaccine would consist of healthcare workers and individuals at high risk of complications from the virus.
An HRSA spokesman said the CICP denies claims for an assortment of reasons, including the legal requirement there be"persuasive" scientific proof that a vaccine directly resulted in injury. CICP only covers medical expenses and lost income not covered by others, such as private health insurance.
HELP OR HARM?
The programs are thought to be crucial by drugmakers, protecting them from accountability in the U.S. market where suits goods have cost them billions of dollars.
Pfizer, which is working on a COVID-19 vaccine with Germany's BioNTech (22UAy. F), expects the U.S. system to give a blueprint for handling liability in different countries.
"We're pursuing similar liability protections away from the USA through contractual and/or legislative efforts, and we believe this is going to be manageable," Pfizer general counsel Doug Lankler informed investors last month.
AstraZeneca said it's obtained protection from liability because of its COVID-19 vaccine from the majority of the nations it's struck provide agreements with.
Individuals who suffer serious injuries from a crisis vaccine in the United States are required to first seek compensation during the CICP, and then, should they decline any award, they could bring a case in court. But they must establish a drugmaker acted with"willful misconduct," which lawyers said would make a case nearly impossible.
Lawrence Karol, 70, of Encino, California made large fatty cysts after obtaining a disease against H1N1 at 2009. It took him almost a year to discover where to file a claim for up to $10,000 in lost earnings and the charge to get rid of a baseball-sized expansion from his arm in which he received his shot.
By the time he got a hearing, he had been told the one-year time limit for claims had passed. The hearing judge said he had no recourse but one:"They told me to go to Congress to alter the vaccine statute of limitation laws," he said. The fund has paid out an average of $216 million annually into an average of 615 claimants each year since 2015, according to HRSA.
Lawyers stated the VICP pays about 75 percent of claims. Examples include witness testimony, public rulings and appeals throughout the federal court system.
The VICP is funded through an excise tax on vaccine doses, and pays fees for attorneys and experts, so claimants frequently have legal representation.
VICP instances can take years, but Gentry said it is nevertheless an improvement on the CICP program which she described as"the right to file and lose."