(Reuters) – A US government program that compensates people who say they have been injured by an emergency vaccine has paid for less than 10% of claims, raising questions about whether the process should be used to deal with any side effects from a coronavirus shot, according to certain attorneys who have filed such claims.
The Countermeasures Injury Compensation Program, run by an agency of the U.S. Department of Health and Human Services, has been designated to address any problems with a COVID-19 vaccine.
Lawyers say the program is insufficient to deal with fast-track coronavirus vaccines.
They say that any COVID-19 vaccine damage should be managed through another HHS program called the "vaccine", a more transparent process with a better registry to compensate people for the rare damage or serious side effects from routine inoculations, such as measles shots.
The National Vaccine Injury Compensation Program includes claims regarding 1
When it comes to dealing with possible damage from a COVID-19 vaccine, "there are major shortcomings that need to be changed" in the American method, said Peter Meyers, an emeritus professor at George Washington University School of Law and former head of Vaccine Injury Litigation Clinic.
Mr. Meyers described the CICP as a "black hole" process handled entirely within the HHS, rather than a court, with no fees for lawyers or expert witnesses, a short window of one year to file claims and limited participation from the applicant.
HHS declined to comment on criticism of using CICP to address potential COVID-19 claims.
Drugmakers including Moderna, Pfizer and AstraZeneca are working to deliver a safe and effective COVID-19 vaccine as early as this year, compressing years of development into months.
The effort has raised concerns among many Americans that a vaccine could be introduced for tens of millions of people before the potential risks are fully known.
The US system shifts responsibility for vaccines to the government and protects drug manufacturers, as widespread vaccination against disease is considered to benefit society.
While billions of vaccine doses have been administered in the United States over the past 30 years, government data show that approximately 1 in a million people suffer a serious injury that justifies compensation.
This year, Congress allocated $ 30 billion for HHS to fight COVID-19, including funding for vaccine development and any necessary compensation. To date, no claims regarding COVID-19 drugs have been submitted to the CICP and the program has not requested specific funding, a spokesman for HHS said.
Of the 485 applications filed since the CICP began reviewing claims in 2010, only 39 people received compensation for a total of $ 5.7 million, according to the Health Resources & Service Administration, which runs the program for HHS.
Almost all claims involved H1N1 vaccine against pandemic influenza, according to information obtained by Mr. Meyers through a Freedom of Information Act request. The CDC estimates that approximately 123 million people over the age of six months received the H1N1 vaccine, also known as swine flu.
"It is not fair to frontline people if they are the first to receive this vaccine and they have to go to the CICP and get little to nothing," said Renée Gentry, head of the Vaccine Injury Litigation Clinic.
U.S. officials have said the first people to receive a successful COVID-19 vaccine would include healthcare professionals and people at high risk for complications from the virus.
An HRSA spokesman said the CICP denies claims for various reasons, including the legal requirement there is "convincing" scientific evidence that a vaccine directly caused harm.CICP only covers medical expenses and lost income not covered by others, such as private health insurance.
Help or harm?
The programs is considered crucial by drug manufacturers and protects them from liability in the U.S. market where processes over products have cost them billions of dollars.
Pfizer, which operates a COVID-19 vaccine n with Germany's BioNTech, expects that the US system will provide a plan for managing responsibilities in other countries.
"We are pursuing similar liability protections outside the United States through contractual and / or regulatory action, and we believe this will be manageable," Pfizer CEO Doug Lankler told investors last month.
AstraZeneca said it had received protection from liability for its COVID-19 vaccine from most countries with which it has concluded supply agreements.
Persons suffering serious injuries from an emergency vaccine in the United States are required to first seek compensation through the CICP, and then, if they refuse any dividend,
Lawrence Karol, 70, of Encino, California, developed large fatty cysts, but they must prove that a drug addict acted with "intentional wrongdoing," which lawyers said would make a case nearly impossible.
after receiving a vaccine against H1N1 in 2009 It took him almost a year to find out where to apply for up to $ 10,000 in lost income and the cost of removing a baseball size from his arm where he got his shot.
When he received a hearing, he was told that a one-year time limit for claims had passed. The hearing judge said he had nothing but one: "They told me to go to Congress to amend the Vaccine Ordinance on Restriction Laws," he said.
Fru. The Gentry of the Vaccine Injury Litigation Clinic said that COVID-19 vaccines should fall under the VICP. The fund has paid out an average of $ 216 million a year to an average of 615 applicants each year since 2015, according to HRSA.
Lawyers said that the VICP pays about 75% of the claims. The cases include testimony, public decisions and appeals through the federal court system.
VICP is funded by an excise tax on vaccine doses and pays fees for lawyers and experts, so applicants often have legal representation.
VICP cases can take years, but Mrs Gentry said it was still an improvement on the CICP program, which she described as "the right to file and lose."
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