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Can You Sue If You're Hurt in a COVID-19 Vaccine Trial?

Close up of doctor's hands vaccinating child
By Andrew Leonatti on September 11, 2020 9:00 AM

Drug companies across the world are racing to develop a COVID-19 vaccine that will hopefully allow us to resume normal activities, and some are already conducting late-stage clinical trials on tens of thousands of healthy people.

But hopes for an end-of-the-year miracle took a bit of a hit this week as drugmaker AstraZeneca announced that it paused its clinical trial because of a "single event of an unexplained illness" in a trial participant. That result shows exactly why clinical trials are so important when it comes to developing vaccines instead of just rushing them to market.

Interest in participating in COVID-19 vaccine trials is high, most likely due to the desire to get back to normal life faster. But before you throw your name in, it's important to think about what could happen if you have a bad reaction.

Liability Protections for Drug Companies Are Strong

In place since 1986, the National Childhood Vaccine Injury Act provides sweeping liability protections for vaccine manufacturers when someone suffers an injury from a vaccine. Congress also established a compensation fund for those injury victims who could not sue drugmakers.

But that law primarily applies to vaccines typically given to children, such as for measles, polio, tetanus, and more.

However, COVID-19 vaccine makers can count on the protection afforded by the Public Readiness and Emergency Preparedness (PREP) Act to shield them from lawsuits. On Feb. 4, U.S. Health and Human Services Secretary Alex Azar declared COVID-19 to be a public health emergency and invoked the PREP Act to shield drugmakers from liability for injuries people suffer from treatments and vaccines.

Winning a Lawsuit Will Be Tough

Under the PREP Act, the only exception to the liability protections vaccine makers enjoy is if they act with "willful misconduct." That means a victim must prove that a vaccine maker acted "intentionally to achieve a wrongful purpose" or "in disregard of a known or obvious risk," according to the Congressional Research Service report cited above,

Lawsuits related to willful misconduct are also "subject to procedural provisions generally favorable to defendants." In short, if you're injured in a COVID-19 vaccine clinical trial, you likely will not have the option to file a lawsuit.

However, if you or a loved one are seriously injured or killed during a COVID-19 trial, the federal government does have the Countermeasures Injury Compensation Program, designed to provide compensation for:

  • Medical expenses related to your injuries
  • Lost income
  • Survivors of those killed in clinical trials

While this could provide some peace of mind about whether you want to volunteer for a COVID-19 vaccine trial, the U.S. does not afford many protections for other clinical trials. As more companies try to pioneer treatments for serious illnesses, it's important to remember what your options might be if something goes wrong.

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