Drug companies worldwide are rushing to create a COVID-19 vaccine that will essentially allow us to resume daily activities, and some are already performing clinical studies on tens of thousands of healthy individuals.
But expectations for an end-of-year breakthrough took a blow this week as drug manufacturer AstraZeneca confirmed it was pausing its clinical study due to a “single case of an unknown disease” in a trial patient. This finding illustrates just why clinical trials are so crucial in building vaccines, rather than simply pushing them to production.
Interest in participating in COVID-19 vaccine trials is strong, most likely due to the wish to move quickly to ordinary life. But before you throw your name in, it’s vital to consider what could happen if you have a negative reaction.
Any personal injury attorney will tell you to be aware of your rights, or lack thereof, before taking part in any sort of drug trial.
Drug Firms Have Exceptionally Strong Liability Protection
The National Childhood Vaccine Injury Act, in effect since 1986, offers broad liability protection for vaccine manufacturers when a vaccine injures someone. Congress has created a reimbursement fund for victims of injuries who couldn’t sue drugmakers.
But the legislation refers specifically to vaccinations typically given to infants, such as measles, polio, tetanus, etc.
COVID-19 pharmaceutical companies, however, can rely on the protections offered by the PREP Act to shield them from litigation. Feb. 4, U.S. Secretary of Health and Human Services, Alex Azar, declared COVID-19 a public health crisis and invoked the PREP Act to protect drugmakers from responsibility for injuries involving medications and vaccines.
Winning a Case Would be Difficult
Under the PREP Act, an exception to this liability immunity vaccine manufacturers receive is if they act with “willful misconduct.” That means a victim must demonstrate that a vaccine company behaved “intentionally to achieve a wrongful objective” or “regardless of a known or obvious danger,” as per the aforementioned Congressional Research Service study,
Litigation relating to intentional wrongdoing is indeed “subject to procedural requirements usually favorable to defendants.” In essence, if you’re injured in a medical study with a COVID-19 vaccine, you probably won’t have the opportunity to file a complaint.
That being said, if you or a loved one was seriously hurt or killed during a COVID-19 trial, the federal government has the Countermeasures Damage Compensation Scheme to pay for:
- Hospital bills for the injuries
- Missing earnings
- Survivors destroyed in clinical trials
Although this can offer some comfort whether you’d like to apply for a COVID-19 vaccine trial, the U.S. does not provide many guarantees for other clinical trials. As more businesses continue to pioneer severe disease therapies, consider what the choices could be if anything goes wrong.