Fact Check: Are pharmaceutical companies immune from COVID-19 vaccine lawsuits?

As of January 19, about 24 million cases of the coronavirus have been reported in the United States and more than 400,000 Americans have died from COVID-19, according to the New York Times.

USA Today reported that President-elect Joe Biden announced his $1.9 trillion stimulus plan on January 14 and set a goal of providing 100 million doses of the COVID-19 vaccines during the first 100 days of his administration.

The Centers for Disease Control and Prevention’s COVID-19 data tracker shows that 10.5 million people have received at least one vaccine dose and that 1.6 million have received both doses.

According to the Associated Press, “Massive coronavirus vaccine trials involving tens of thousands of participants have so far surfaced no signs of serious side effects, and few unexpected adverse reactions have been reported in the early days of COVID-19 vaccine distribution in the U.S.”

Though millions of people have been vaccinated, some Americans are concerned about the side effects of the vaccines and if pharmaceutical companies such as Moderna and Pfizer could be liable for injuries.

The Claim

On January 13, Governor Mike DeWine (R-Ohio) posted a tweet reassuring the public that the COVID-19 vaccines are safe.

One poster replied to DeWine, claiming that “Pharmaceutical companies have no liability for their vaccine products. I ask, if they are so “safe” why can you not seek damages in a court of law if you are harmed by them?”

The Facts

According to 42 U.S. Code § 300aa–22, “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

In other words, companies that manufacture vaccines are not liable if someone has an allergic reaction or injury after being vaccinated.

However, individuals can file a petition with the National Vaccine Injury Compensation Program (VICP) administered by the U.S. Department of Health and Human Services (HHS) to receive compensation if they are found to have been injured by one of the vaccines covered by VICP. According to the Health Resources and Services Administration under HHS, “even in cases in which such a finding is not made, petitioners may receive compensation through a settlement.”

VICP, also known as “vaccine court” has been accepting petitions, also known as claims, since 1988, and has paid about $4.4 billion in overall compensation, according to CNBC.

Though VICP covers vaccines for diseases including human papillomavirus (HPV), measles, mumps, polio and seasonal influenza, it does not cover any COVID-19 vaccines.

In 2005, the Public Readiness and Emergency Preparedness Act (PREP) was created to protect from liability pharmaceutical companies that make or distribute vaccines unless there is “willful misconduct” by the company.

HHS Secretary Alex Azar invoked PREP in February in response to the pandemic, declaring COVID-19 to be “a public health emergency warranting liability protections for covered countermeasures.”

This means that companies like Moderna and Pfizer are protected from lawsuits regarding their COVID-19 vaccines until 2024.

According to CNBC, “You also can’t sue the Food and Drug Administration for authorizing a vaccine for emergency use, nor can you hold your employer accountable if they mandate inoculation as a condition of employment.”

However, the PREP Act also created the Countermeasures Injury Compensation Program (CICP), which provides benefits to people who claim that they suffered injuries from vaccines under emergency authorization.

There are a few key differences between VICP and CICP.

The Associated Press reported that VICP has paid much more in compensation than CICP has. Only 29 out of 499 people who made claims under CICP received compensation.

Since the late 1980s, VICP has provided $4.4 billion in total compensation, with an average of $570,000 per claim. Since 2005, CICP has provided petitioners, who mostly made claims about the H1N1 swine flu vaccine, $6 million in compensation, with an average of $200,000 per claim. According to the Associated Press, “payments in most death cases are capped at $370,376” for CICP.

VICP allows individuals to make claims within three years of their first symptom. CICP, on the other hand, allows petitioners only one year from the date of vaccination.

CICP doesn’t pay fees for lawyers or expert witnesses or provide awards for suffering or damages; VICP does. VICP also permits appeals all the way to the Supreme Court.

In other words, people who make claims about injuries or allergic reactions to either of the COVID-19 vaccines have less time to make their petitions than people who have filed claims for injuries from vaccines related to the measles or the flu. They also are less likely to receive compensation for injuries from COVID-19 vaccines, and if they do receive compensation, it likely will be a smaller amount.

The Ruling

True.

Pharmaceutical companies are protected from liability regarding the COVID-19 vaccines. If someone has an allergic reaction or injury from one of the vaccines, they can petition to receive compensation from the Department of Health and Human Services’ (HHS) Countermeasures Injury Compensation Program (CICP).

The National Vaccine Injury Compensation Program (VICP), which also falls under the jurisdiction of HHS, has a better record of providing compensation to people who claim injury from a vaccine than CICP but covers vaccines for diseases such as polio and seasonal influenza, not COVID-19.