The Pfizer-BioNTech COVID-19 vaccine received full approval from the Food and Drug Administration (FDA) on Aug. 23, 2021. It is now the first COVID-19 vaccine to be approved by the FDA in the United States and is also the FDA’s fastest vaccine approval ever.
The Centers for Disease Control and Prevention (CDC) says side effects after receiving a COVID-19 vaccine are typically mild and short-lived. But for months, many people have asked whether they can bring a lawsuit against a COVID-19 vaccine manufacturer if they were to have a severe reaction, like injury or death, after getting vaccinated.
THE QUESTION
Can you sue a manufacturer if you get a COVID-19 vaccine injury?
THE SOURCES
THE ANSWER
No, you can’t sue a manufacturer if you get a COVID-19 vaccine injury. However, you could file for benefits under the Countermeasures Injury Compensation Program (CICP).
WHAT WE FOUND
The CDC defines a vaccine injury, or an adverse event following immunization, as “any health problem that happens after vaccination.”
“An adverse event can be a true adverse reaction, also known as a side effect, that is related to the vaccine, or a coincidental event that happened following vaccination,” the CDC said on its website.
“Usually, vaccine side effects are identified during clinical trials. The intensity of these reactions may range from mild to moderate to severe. They often resolve on their own, and may or may not require medical intervention. Depending on severity, an adverse reaction may also be considered a serious adverse event,” the CDC said.
On Feb. 4, 2020, former Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act (PREP Act). The declaration grants companies like Pfizer, Moderna or Johnson & Johnson liability protection — meaning they cannot be sued for money damages in court — if a person experiences an adverse reaction to the COVID-19 vaccines, except for claims involving “willful misconduct.”
A representative from the Health Resources & Services Administration (HRSA) explained to VERIFY by email that the COVID-19 vaccines are “covered countermeasures” under the Countermeasures Injury Compensation Program (CICP), which is a fund authorized under the PREP Act.
According to the HRSA, the PREP Act authorizes the CICP to provide benefits to certain people who sustain a covered serious physical injury as the direct result of the administration or use of the COVID-19 vaccines. HRSA says the CICP may also provide benefits to certain families or beneficiaries of people who die as a direct result of the administration or use of the COVID-19 vaccines, but the program is only authorized to provide compensation, not liability protection.
Sara Tucker is a partner at Womble Bond Dickinson in Atlanta. Her area of expertise is FDA regulatory and product liability litigation. She tells VERIFY that because the COVID-19 vaccines fall under the countermeasure definition of the PREP Act, a person who may have a vaccine injury cannot sue the manufacturer. This includes Pfizer's FDA-approved vaccine.
“Congress has made it such that the trade-off in order to get these drugs on the market as quickly as possible was giving the manufacturers immunity from liability,” said Tucker. “The CICP provides a way for you, if you are injured or someone you love is injured or dies, to file a claim and get benefits from the government as a result of that, but no, you cannot just sue the manufacturers unless you can prove there is some sort of willful misconduct going on, which would be pretty difficult to prove.”
If a COVID-19 vaccine injury occurs, individuals can apply for compensation from the CICP. Tucker says all the information a person needs to file a claim is online.
“You would basically go to the website — you would file a claim with the agency, and then they are going to want proof that you were directly injured or the vaccine actually caused your injury,” said Tucker. “So, you're going to work with the agency in order to provide the medical records and things along those lines, and then someone is going to assess whether or not that claim was caused by the vaccine. If it is caused by the vaccine, then you would end up getting benefits.”
Tucker says people who do file for compensation will most likely not recover as much money from the program as they would if they were to sue in court or get money for pain and suffering. She also says if a person does have a vaccine injury, they only have a year to file a claim with the program.
“There's a cap of up to $50,000 a year for your lost wages and out-of-pocket medical expenses. You cannot recover your legal fees. And if there's a death associated with it that they can link to the vaccine, that death benefit is capped at $370,000-ish dollars,” said Tucker.
According to HRSA data, out of 2,186 CICP claims that have been filed since 2010, the program has paid compensation for 29, totaling more than $6 million. An additional 10 CICP claims were eligible for compensation after a review of the required medical records and documentation, but in these cases, the HRSA says there were no eligible reported medical expenses or lost employment income for the CICP to compensate.
Tucker says if someone still wants to try to sue the manufacturer instead of filing a claim through the CICP, she recommends speaking to an attorney first.
“If you can show that there was willful misconduct on the part of the manufacturer, depending on what the claim is, you may be able to still sue in court. But for the most part, yes, [the CICP] would be the only avenue to pursue,” said Tucker.
According to the CDC, the systems in place to monitor the safety of the COVID-19 vaccines have found only two serious types of health problems after vaccination, both of which they say are rare. These are anaphylaxis, or a severe allergic reaction, and thrombosis with thrombocytopenia syndrome (TTS) after vaccination with the Johnson & Johnson COVID-19 vaccine.
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