Biden administration delays payment cuts for sore-shoulder injury claims from vaccines

The Biden administration has postponed a rule change that would eliminate compensation for the most common type of vaccine injury paid under a federal program.

The rule change to remove vaccine-caused shoulder injuries from the National Vaccine Injury Compensation Program was set to begin Feb. 22.

However, in a notice posted Friday, the U.S. Department of Health and Human Services said it will delay the rule until April 23 and seek more public input about any "legal, factual, or policy issues raised by the underlying rule."

More than 2,200 Americans since 2017 have filed shoulder-injury claims to the National Vaccine Injury Compensation Program, also known as vaccine court. But a rule change signed last month by then-U.S. Department of Health and Human Services Secretary Alex Azar sought to remove shoulder injuries from the program.

The shoulder-injury rule would not immediately affect the more than one million Americans who get vaccinated against COVID-19 every day to slow a once-in-a-century virus that's killed more than 475,000 Americans. COVID-19 vaccine injury claims are routed through another program called the Countermeasures Injury Compensation Program, which has rejected 90% of vaccine-injury claims over the past decade.

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Nevertheless, experts say adding barriers to those who experience rare side effects sends the wrong message as the nation pursues an unprecedented immunization campaign.

"We need to know the government has our back if they’re pushing us so hard to get vaccinated," said Katharine Van Tassel, a visiting professor of law at Case Western Reserve School of Law in Cleveland.

Established under the National Childhood Vaccine Injury Act of 1986, federal vaccine court handles rare cases of people who have serious side effects from a recommended vaccine. The court ensures quick compensation for legitimate injury victims and protects vaccine manufacturers from liability. The system ensures a steady supply of vaccine at low costs for immunizations that provide broad public health benefits.

The court has a list of "table injuries" making people eligible for compensation if they show they received the covered vaccine and document side effects within a set period. If an alleged harm is not listed as a table injury, a person must prove a vaccine caused the injury.

In documents posted as part of the rulemaking process, HHS' lawyers said removing claims of SIRVA, or shoulder injury related to vaccine administration, as a table injury would ease a backlog of cases and allow more timely decisions for other claims. Government lawyers argued shoulder injuries overwhelmingly are caused by improperly-administered vaccines, not vaccines' contents.

David Carney, a Philadelphia attorney who specializes in vaccine-injury cases, said delaying the rule will allow HHS time to "take a longer and more thorough inspection at how this rule will negatively affect the public, create public mistrust in the vaccine process in the midst of a global pandemic, and expose our healthcare workers to unnecessary civil lawsuits."

Officials with the Health Resources Services Administration, which oversees vaccine court, declined comment beyond the notice published Friday in the Federal Register.

Van Tassel said even a delayed rule change will not address the bigger challenges of ensuring fair compensation for COVID-19 vaccine injury claims.

The Food and Drug Administration has granted emergency authorization for two vaccines, saying they're safe and effective. Clinical studies with tens of thousands of people found vaccines from Pfizer-BioNTech and Moderna are highly effective and safe, with minor side effects such as soreness, redness and swelling.

Johnson & Johnson also has asked the FDA to authorize its COVID-19 vaccine for use in adults.

Because the vaccines were authorized during a public health emergency and not yet indicated for routine use in children or pregnant women, injury claims are handled through the countermeasures program instead of vaccine court.

Clinical trials are underway for children aged 12 and Dr. Anthony Fauci, the nation's top infectious disease doctor, said he expects children could get vaccinated by spring or summer.

COVID-19 vaccine injury victims will face a more difficult path to get compensation under countermeasures because it has a higher burden of proof, allows only one year to file a claim and limits awards, Van Tassel said.

Frontline workers such as hospital staff, grocery clerks and meatpacking employees are among the first to get vaccinated, but they are less likely to get compensated for injuries due to the tougher standards under countermeasures, Van Tassel said.

"This is a very big problem that Congress needs to address now because it’s a matter of trust," said Van Tassel. "If you are a perfectly healthy person and you are going to vaccinate for the good of the community, the community should be there, have your back and support you, if you are in fact injured as a result of that act of taking that vaccine."

This article originally appeared on USA TODAY: HHS to review Trump administration rule to halt common vaccine injury payments