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Home » COVID-19 vaccine liability – new information after FDA approval

COVID-19 vaccine liability – new information after FDA approval

This article about COVID-19 vaccine liability was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

A number of questions have come up around COVID-19 vaccine liability. I previously addressed the general framework for liability. In this article, I will try to outline how individuals may be liable for potential harm from COVID-19 vaccines especially in light of the recent FDA approval of the Pfizer vaccine.

Also, this short post addresses a bit of misinformation that appears to have come up from anti-vaccine sources.

COVID-19 vaccine liability
Photo by Daniel Schludi on Unsplash

Background on COVID-19 vaccine liability

In essence, COVID-19 vaccines manufacturers, distributors, and administrators are currently almost completely exempt from liability because the vaccines – and other COVID-19 products – are under a  Public Readiness and Emergency Preparedness Act (PREP) declaration.

The only exception – the only situation where you can sue these actors – is if you can show they engaged in “willful misconduct”. Willful misconduct required that someone act:

  • intentionally to achieve a wrongful purpose;
  • knowingly without legal or factual justification; and 
  • in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.

Only if all these conditions are fulfilled, can you sue one of the “covered persons” under the declaration. That is obviously a very narrow exception. 

People harmed by a vaccine covered by the declaration may turn for compensation to the Countermeasures Injury Compensation Program – which is hard to use.

Photo by CDC on Unsplash

Anti-vaccine misinformation

In short, apparently, anti-vaccine groups are spreading a claim that now that the FDA licensed Pfizer’s COVID-19 vaccine, the newly licensed vaccine is no longer protected from liability. The claim is being spread as a corollary to the baseless claim that the FDA did not really license Pfizer’s vaccine in full, addressed by Orac in detail here. Apparently, as part of that strange claim, anti-vaccine activists tried to argue that the Pfizer vaccine is not protected from liability.

As with most anti-vaccine claims, that claim is incorrect.  Under the PREP declaration, liability protections extend to “covered countermeasures”:

Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.

Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

A qualified pandemic product is:

“A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is

(i) manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause;

(ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (emphasis added)

The declaration explains that:

To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use .

In other words, a licensed vaccine can certainty be a covered countermeasure, as long as it’s designed to “prevent” or “mitigate” COVID-19 or transmission of the virus. Obviously, Pfizer’s vaccine falls under that definition. The declaration also extends to EUA vaccines, but it certainly and easily covers licensed vaccines, too. Pfizer’s new licensed vaccine falls under the declaration. The anti-vaccine claim is incorrect.

Attempting to suggest this is a trick focusing on Pfizer’s vaccine also misses the scope and purpose of the PREP declaration. The reason for liability protection for all products for treating or preventing COVID-19 during the pandemic – vaccines or not, licensed or not – is that Congress decided that during a pandemic it wants products out fast, and it doesn’t want manufacturers slowly bringing them to market because of liability concerns, or doctors hesitating to give it.

To balance that limit a compensation program was created, though, in my view, the compensation program is not generous enough.

The broad liability protections were put in place in early 2020. Before any vaccines were out. They don’t imply anything about the actual safety of any of the products, because they’re broad and prospective. The Secretary didn’t know what the safety profile of the vaccines will be then, no one did.

In other words, this is because we are in a pandemic, not because of anything about the specific vaccines.

COVID-19 vaccine liability
Photo by Anthony Shkraba on

What about off-label use in children under 12?

A trickier question I was asked was what about using the vaccine off-label in younger children. Generally off-label prescription of licensed products is legal (in contrast to EUA products, which should be used as authorized).

But it’s tricky in this case. The American Academy of Pediatrics (AAP) recommended against doing that without a recommendation, and I think they make a strong case against it. The Centers for Disease Control and Protection (CDC), apparently, suggested doing so could lose clinicians their liability protection. They also pointed out that doing so could risk losing contracts and payment. 

I was asked if the off-label prescription is covered by the PREP declaration by the talented Prof. Lindsay Wiley.

I think that this is a trickier question. My inclination is to say that off-label use of Pfizer’s vaccine in children is not protected under the PREP declaration, but there are other opinions on this matter.

For the view that it is not protected, I think the nature of the PREP act suggests that it was not intending to provide liability to people using a vaccine that is under a EUA for specific use against the EUA.

Pfizer’s vaccine is licensed, but for 16 and up, and the FDA expressly maintained the EUA for 12-15 – and under 12 is likely closer to that. To me, that suggests that there is no intent to include under 12 in the PREP declaration.

The PREP declaration is also an agency regulation. If the CDC’s interpretation of it is seen as an agency’s interpretation of its own regulation, the CDC’s interpretation of the declaration – that use in 12 and under is not included – would get very high deference from the courts.  

However, there are counters. As pointed out by my colleague, Prof. Govind Persad, the language of the PREP declaration suggests that licensed products are covered. The PREP declaration does not distinguish between off and on-label usages for this purpose and suggests liability protections are broad.

Off-label prescription, which is generally legal, likely does not fit the stringent requirements of “willful misconduct”, the exception to the PREP declaration. And it’s not clear CDC is the right agency entitled to deference – the Secretary of Health and Human Services (HHS) (who issues PREP declarations) and the Director of CDC are different people, though CDC is under HHS. Of course, the Secretary can easily embrace or agree with the CDC’s interpretation. 

My opinion

I think this could go either way, and I am of the view that a provider who prescribes vaccines to children under 12 may be taking a liability risk. Of course, in the current situation, with some states seeing unconscionably high numbers of children hospitalized or dying, in some circumstances that may be the right thing to do anyway. 

Dorit Rubinstein Reiss

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