COVID-19 era highlights US ‘black hole’ compensation fund for pandemic vaccine injuries


(Reuters) – A US government program that compensates those who say they have been harmed by an emergency vaccine has paid less than 10% of claims, raising questions about whether the process used coronovirus shots This should be done to remove any possible side effects. According to some lawyers, who have filed such claims.

FILE PHOTO: In this illustration taken on April 10, 2020, a woman holds a small bottle labeled with a “Vaccine Cod-19” sticker and a medical syringe. REUTERS / Dado Ruvic / Illustration / File Photo

The Countermeasures Injury Compensation Program (CICP), operated by an agency under the US Department of Health and Human Services (HHS), is designated to handle any issues with the COVID-19 vaccine.

Lawyers say the program is insufficient to address the fast-paced coronovirus vaccine bit.ly/bigpicturecovid.

They state that any COVID-19 vaccine injuries should be controlled through a separate HHS program known as the “Vaccine Court” for people with rare injuries or routine inoculations for serious side effects. Is a more transparent process with better records of compensation, such as measles shots.

The National Vaccine Injury Compensation Program (VICP) claims about 16 regular vaccines recommended by the Centers for Disease Control and Prevention (CDC).

When it comes to addressing any potential pitfalls from the COVID-19 vaccine, America’s approach includes “Peter Meyers, who needs to make major changes”, an emeritus professor at George Washington University School of Law and former vaccine The director said. Injury Litigation Clinic.

Meyers described the CICP as a “black hole” process handled entirely within HHS rather than in a courtroom, without fees for lawyers or expert witnesses, for filing claims and limited participation by the claimant A small window.

HHS declined to comment on criticisms of the use of CICP to process potential COVID-19 claims.

Drug manufacturers with modernity (MRNA.O), Pfizer (PFE.N) And AstraZeneca (AZN.L) Are working to deliver a safe and effective vaccine against COVID-19 such as earlier this year, narrowing the years of development to months.

The effort has caused concern among many Americans that millions of people may be vaccinated before a potential threat is fully known.

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The US system transfers liability for vaccines to the government, and shields drug manufacturers, as widespread vaccination against the disease is considered an advantage for society.

While billions of vaccine supplements have been administered in the United States over the past 30 years, government data shows that approximately 1 in a million people suffer from a serious injury that compensates for warrants.

Congress gave HHS another $ 30 billion this year to fight COVID-19, including vaccine development and possibly any necessary compensation. A HHS spokesperson said that no claims regarding COVID-19 drugs have been made to the CICP yet and the program has not requested specific funding.

According to the Health Resources and Services Administration (HRSA), the CICP has launched 485 claims since launching a claims review in 2010, of which only 39 people have received compensation of $ 5.7 million, which runs the program for HHS .

According to information obtained by Meyers through a Freedom of Information request, almost all claims involved H1N1 pandemic flu vaccines. The CDC estimates that 123 million people over six months of age received the vaccine for H1N1, also known as swine flu.

Renee Gentry, director of the Vaccine Injury Litigation Clinic, said, “It is not fair for people who get the vaccine if they are the first to get this vaccine and they have to go to the CICP and do nothing.”

US officials have said that the first people to receive a successful COVID-19 vaccine would include health workers and those at high risk of complications from the virus.

A spokesperson for HRSA said that CICP denies the claims for a number of reasons, including the legal requirement that “scientific” evidence that a vaccine directly causes injury. CICP only covers medical costs and lost income covered by others such as private health insurance.

Help or harm?

The program is considered important by drug manufacturers, protecting them from liability in the US market where lawsuits on products have cost them billions of dollars.

Pfizer, which is working on the COVID-19 vaccine with BioNTech (Germany)22UAy.F), Expects the US system to provide a blueprint for dealing with liability in other countries.

“We are pursuing similar liability protections outside the United States through contractual and / or legislative efforts, and we believe this is going to be manageable,” Doug Lankler, Pfizer’s general manager, told investors last month Told.

AstraZeneca said it had secured liability from most of its countries for its COVID-19 vaccine, with which it had supply agreements.

Those who suffer serious injuries from an emergency vaccine in the United States first require compensation through the CICP, and then, if they reject any award, they can bring a case to court. However, he would have to prove a drugmaker with “willful misconduct”, which lawyers said would make a case almost impossible.

Lawrence Karol, 70, of Encono, California, developed large fatty cysts in 2009 after receiving a vaccine against H1N1. It took him nearly a year to file a claim of up to $ 10,000 in lost income and the cost of removing a baseball. The size of the rise with his hand where he received his shot.

By the time he got the hearing, he was told that a one-year deadline had passed for the claims. The trial judge said he had no recourse but one: “He told me that I would go to Congress to change the vaccine law of the border laws,” he said.

Gentry from the Vaccine Injury Litigation Clinic stated that the COVID-19 vaccine should be covered under the VICP. According to HRSA, the fund has paid an average of $ 216 million annually to an average of 615 claimants since 2015.

Lawyers said that VICP pays about 75% of the claims. The cases include testimony, public rulings and appeals through the federal court system.

The VICP is funded by excise taxes on vaccine supplements, and pays fees for lawyers and specialists, so claimants often have legal representation.

VICP cases can take years, but Gentry said it is still an improvement over the CICP program that he described as “right to file and lose”.

Reporting by Tom Hales in Wilmington, Delaware; Additional reporting by Michael Erman in Maplewood, New Jersey; Editing by Michelle Gershberg and Grant McCool

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