PREP Act Protections for COVID-19 Vaccine Liability

Entities engaged in the manufacture, distribution, and administration of most routine vaccinations are accustomed to the liability protections afforded bythe 1986 Vaccine Act.But the COVID-19 vaccine, expected to be administered en masse by the end of 2021, is not one of those vaccines. Instead, the scope of liability for injury claims relating to the COVID vaccine will be governed by the Public Readiness and Emergency Preparedness Act (the “PREP Act”). In contrast to the Vaccine Act, sparse precedent exists from which to infer how PREP Act protections will apply to the potentially numerous and varied COVID-19 vaccine-related claims that could be on the horizon. It is critical for entities involved in the production, supply, and administration of COVID vaccines to understand the scope of immunity provided under the PREP Act, its differences from the Vaccine Act, and the manner in which the public at large will be able to seek recourse for vaccine-related claims stemming from receipt of a COVID vaccine.

Congress enacted The National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 et seq.) (the “Vaccine Act”) to address vaccine shortages that occurred following a spate of successful vaccine injury lawsuits against manufacturers and other entities in vaccine supply chains that caused some to withdraw from the market. The Vaccine Act established a no-fault compensation program for vaccine-related injuries that functions as an alternative to the civil tort system. Rather than file a product liability suit against a vaccine manufacturer or distributor in civil court, a person alleging an injury caused by a covered vaccine (broadly, vaccines recommended for routine administration to children) must first seek compensation through the National Vaccine Injury Compensation Program (VICP). Claims are adjudicated in a special division of the Court of Federal Claims dedicated to vaccine injury cases in civil-court-like proceedings with public decisions, and are appealable to the United States Court of Federal Claims and Federal Circuit.

While the Vaccine Act has insulated vaccine suppliers from many vaccine-related claims for the past 30+ years, it does not afford complete protection. The Vaccine Act largely only covers claims for injuries caused by receipt of a properly formulated vaccine itself (with a few exceptions, subject to debate).Thus, while the Vaccine Act preempts most design defect and failure to warn claims, manufacturing defect claims can typically still be heard in civil court. Additionally, claims relating to circumstances surrounding vaccine administration but unrelated to the vaccine itself—such as assault and battery for administering a vaccine without consent or claims relating to failure to vaccinate—are generally not preempted.

In contrast, the scope of liability for claims relating to the COVID-19 vaccine will be governed by PREP Act protections for Covered Countermeasures. The PREP Act aims to facilitate emergency response by granting broad immunity to Covered Persons against claims for losses caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of covered countermeasures. Earlier this month, the Department of Health and Human Services expanded the scope of PREP Act immunity even further with its “Fourth Amendment” to the original March COVID-19 Declaration. Among other things, PREP Act immunity now extends to purely private actors, which could include entities such as retail pharmacies, private nursing homes, or even private employers or private schools involved in vaccine administration. The PREP Act’s broad immunities extend well beyond the bounds of Vaccine Act protections because they include many types of claims ancillary to receipt of the vaccine itself. Unlike the Vaccine Act, not only should PREP Act immunity preempt claims for manufacturing defects, it should also extend to torts directly relating to vaccine administration, such as assault and battery. The Department of Health and Human Services has even indicated that claims for failure to vaccinate should fall within the ambit of PREP Act protections under certain circumstances.

Like the Vaccine Act, the PREP Act also establishes an alternative compensation program—the Countermeasure Injury Compensation Program (CICP)—through which individuals claiming COVID vaccine-related injuries may seek compensation. But the similarities largely end there. In contrast to the Vaccine Program, the inner workings of CICP are unknown and untested, and have been criticized for their lack of transparency. CICP claims are adjudicated administratively by the Department of Health and Human Services, with no public decisions and very limited appeal rights. In its 10 years of existence, CICP has adjudicated only a tiny fraction of the claims seen by the Vaccine Program (~500 CICP claims compared to more than 22,000 VICP claims).

How can entities involved with the COVID vaccine best position themselves to take advantage of PREP Act immunity?

• Be aware that the CICP is the appropriate forum for claims relating to a COVID vaccine. Armed with this knowledge, entities can immediately assess potential immunity with respect to any COVID vaccine-related claim. Additionally, entities should be aware that the scope of PREP Act immunity is different from—and far broader than—Vaccine Act protections. So dismissal may be available for COVID vaccine-related claims where it wouldn’t be for claims involving other vaccines.
• Consider educating the public that CICP is the appropriate forum for claims relating to a COVID vaccine. This strategy could help avoid improper civil litigation in the first instance and, in turn, reduce the burden on entities of moving to dismiss.
• Watch for developments affecting the scope of COVID vaccine-related liability in the future. At present, it remains unclear what will happen once PREP Act immunity protections expire (immunity is generally set to expire on October 1, 2024—though manufacturers are granted an additional year to arrange for the disposition of Covered Countermeasures). While it is possible that COVID vaccines could be added to the Vaccine Program, there is no clear indication yet that this will occur, so liability with respect to future vaccine recipients remains unclear.

Cheri Falvey, Partner Chalana Damron, Counsel, Hilary Johnson, Counsel, Mariam Sarwar, Associate; all with Crowell & Moring