Tort Immunity Waiver for Vaccine Injuries: Ethical and Legal Perspectives

Abstract

The COVID pandemic highlighted the importance of vaccine development and availability worldwide. Operation Warp-Speed in the United States accelerated vaccine production by several major pharmaceutical manufacturers, averting some of the normal administrative processes. The result has been a financial windfall for those companies. Some recent data has shown that the COVID vaccine can cause negative side effects in some patients. There are provisions in U.S. law that allow victims of vaccine injuries to recover compensation through the court system. However, even then tort remedies are limited by federal law. Since the review process was rushed during the pandemic, should tort immunity still be available to those pharmaceutical companies? This paper will discuss the legal and ethical issues involved in vaccine tort immunity.

1. Background

Vaccines have the potential to cause harm to otherwise healthy people, which necessitates the scientific review process conducted by the Food and Drug Administration (FDA) in the United States and the European Medicines Agency in the EU (Halabi et al. 2021, pp. 111–62 at 119). Generally, the potential for legal liability for injury or harm from vaccines would incentivize manufacturers to ensure the safety of their product. However, vaccine manufacturers in the United States benefit from partial tort immunity under the National Childhood Vaccine Injury Act (NCVIA) of 1986 (HRSA 2017),1 the stated purposes of which are “to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines” (HRSA 2017).

This paper will examine the legal and ethical issues involved in tort immunity for vaccine manufacturers, with a focus on the COVID-19 vaccines. We will compare the two no-fault injury compensation programs for vaccine injuries in the U.S., the Countermeasures Injury Compensation Program (CICP) and the National Vaccine Injury Compensation Program (VICP). COVID vaccine injuries can be compensated under the CICP but not under the VICP. Finally, we will examine vaccine immunity programs internationally and discuss ethical issues surrounding vaccine tort immunity.

2. COVID-19 Vaccines

Without a doubt, tort immunity and patent protections provided companies with some motivation to develop and produce COVID vaccines in record time (Melimopoulos 2021). In the U.S., Operation Warp Speed was the government initiative to develop vaccines at a rapid rate, and those pharmaceutical manufacturers obliged while expecting protection from subsequent lawsuits (Chahede 2021–2022, pp. 14–25).

Those companies have reaped profits from the fast-track approval process as well. Notably, Pfizer’s COVID vaccine earned over $37 billion in global sales in 2022, although sales dropped to $3.38 billion in 2024 (Satija and Erman 2025). Moderna recorded $17.6 billion in revenue in 2021, (Melimopoulos 2021) with sales of $1.8 billion in 2024 (Wingrove 2024). Moderna may now be taking a more aggressive stance with regard to protection of its vaccine because its Spikevax vaccine is one of its few products on the market, although it is developing other mRNA vaccines, including a new RSV vaccine. The U.S. government had introduced a recommended regime of annual COVID vaccines, which could provide a steady stream of revenue for producers of those vaccines. It is no surprise that both Pfizer and Moderna recently announced price increases for future COVID vaccines, from about $20.69 per dose when it was paid by the federal government (Hiltzik 2023) to over $200 per dose on the commercial market for people without insurance (Howard 2024). However, in May, 2025, the HHS, under new Secretary Robert F. Kennedy Jr., announced guidance that COVID vaccines should be given based on risk and shared clinical decision making, downgrading the previous universal vaccine recommendation (Schwartz 2025). This will undoubtedly have an impact on sales of COVID vaccines and profits of both companies.

Changes in administrative rules have an impact on profits, and pharmaceutical companies look for stable avenues to produce profitable vaccines. Without tort immunity, pharma companies might be reluctant to formulate and develop new vaccines like the COVID vaccine. This becomes a critical issue when vaccination has become a medical, social, legal, moral and religious obligation in many countries around the world (Rashi 2021). Nonetheless, a lack of regional vaccine manufacturing capacity is correlated with immunization rates and thus exacerbates vaccine equity issues (Hatti 2022). These factors created the need to incentivize pharmaceutical companies to manufacture vaccines.

3. PREP Act

The National Influenza Immunization Program (NIIP) was initially developed in 1976 to address a swine flu outbreak. President Ford signed an amendment to the Tort Claims Act making a suit against the federal government the only remedy for damages arising from swine flu vaccinations (Meintjes 2021). The federal government agreed to indemnify pharmaceutical companies for claims based on the fast-tracked flu vaccines (ibid., p. 114).

Subsequently, the PREP Act was signed in 2005 by President Bush to “develop products to counter pandemic flu and other disease threats” (CIDRAP 2005). While many in Congress were supportive, Senator Edward Kennedy opposed the bill as a “Christmas gift to the drug industry and a bag of coal to everyday Americans” because the act would make it more difficult to bring suit against drug companies (Meintjes 2021, p. 115). Under the PREP Act, the Department of Health and Human Services (HHS) has broad discretion to issue a declaration in times of public health emergencies. It should be noted that the Department is led by the Secretary of Health and Human Services. This person is nominated by the President and must be confirmed by the Senate. The Secretary serves as the principal advisor to the President on all health and human services matters (Rovner 2025). A declaration by the HHS Secretary is broad and not reviewable by any court (Holland 2018, pp. 415–62). When a declaration is issued, “covered persons” as defined in the act are immune “from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or the use by an individual of a covered countermeasure.” (Chahede 2021–2022, p. 17). Covered persons include manufacturers or distributors of countermeasures, which would include pandemic products, drugs or other medical devices.

However, a covered person who engages in willful misconduct, intentionally bringing about a wrongful purpose or reckless disregard for risk, is not covered by the act’s immunity provisions (ibid., p. 18). Actions for willful misconduct must be filed in federal district court and heard by a three-judge panel. The standard for liability is “clear and convincing evidence” as opposed to the preponderance of evidence standard typically used in civil courts (Holland 2018, p. 449). In other words, a suit for willful misconduct against a vaccine manufacturer under the PREP Act is extremely difficult to win.

4. CICP and VICP

The United States has two distinct no-fault injury compensation programs for individuals who are injured by vaccines—the Countermeasures Injury Compensation Program (CICP) and the National Vaccine Injury Compensation Program (VICP). This section will address the similarities and differences between these two programs. In 2009, Congress created the CICP to provide compensation for injuries resulting from the manufacture, development, or administration of vaccines or other countermeasures. Compensation from this program is based on whether the claimant suffered death or serious injury by a vaccine. In 1986, the NCVIA created the VICP, which provides an administrative means of compensating eligible petitioners for “unavoidable adverse side effects” sustained from CDC-recommended vaccines for children and pregnant women (HRSA 2017). It was established as a no-fault alternative to the court system for resolving vaccine injuries (Meissner et al. 2019, pp. 343–44). VICP tort immunity applies to so-called “unavoidable” side effects, involving inherent and expected risks described in the Vaccine Injury Table (HRSA 2017). Notably, tort immunity does not apply if the injuries are due to: “(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 351, (B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or (C) other criminal or illegal activity relating to the safety and effectiveness of vaccines, which activity related to the vaccine-related injury or death for which the civil action was brought” (HRSA 2017). This type of partial tort immunity protects an entity from being liable for some types of wrongs, but it is not a complete shield from liability. It is often granted to governmental entities or based on certain conditions.

For a category of vaccines to be covered by the VICP, the vaccines must be recommended for routine administration to children and/or pregnant women by the Centers for Disease Control and Prevention, subject to an excise tax by federal law, and added to the Vaccine Injury Table by the Secretary of Health and Human Services (HRSA 2023). The Vaccine Injury Table lists both the covered vaccines and the recognized conditions, injuries, disabilities, and illnesses that are presumed to be caused by them based on recommendations of the US Advisory Committee on Immunization Practices (ACIP) (Thompson et al. 2020). The role of the table is to simplify the claims process by creating a legal presumption of causation, making it easier for claimants to be compensated. Other injuries not listed on the Vaccine Injury Table may be eligible for compensation but must be established by traditional causation (Engstrom 2015, p. 1631). The Vaccine Injury Table information concerning vaccines and conditions or illnesses may be modified by the Secretary of HHS based on published research, public input, or reports from the National Academy of Medicine (Meissner et al. 2019, pp. 343–44). COVID vaccines are unlikely to be included on the Vaccine Injury Table since it would require medical evidence and expert testimony to prove that the COVID vaccine was the cause of specific injuries. Moreover, since COVID vaccines were recently removed from the list of recommended vaccines by HHS, they are ineligible for inclusion on the Vaccine Injury Table absent action by Congress.

Administration of the VICP and CICP differs, further affecting claimants. The VICP is administered by the Health Resources Services Administration (HRSA), and the Civil Division of the US Department of Justice represents the government in litigation (Thompson et al. 2020). Claimants file in the US Court of Federal Claims seeking compensation from the Vaccine Trust Fund and may also recover court costs and attorney’s fees (Civil Division, U.S. Department of Justice 2023). The VICP has a court, judge, and provides a right to introduce evidence of injury. A decision denying relief can be appealed (Chahede 2021–2022, p. 25). The CICP is administered by HHS also through HRSA. Claimants must file a request for benefits form within a year of receiving the vaccine, and it proceeds through a medical review process within the HRSA. Compensation is limited, does not include attorney’s fees, and the decision of the HRSA is not appealable. The CICP was clearly not prepared for COVID claims, as it did not have the staff to adjudicate or the systems to process the large number of claims (U.S. Government Accountability Office 2024).

There are also differences in how claims are paid if a claimant can prove injury. Currently, the VICP is funded by a federal excise tax of $0.75 on each vaccine dose. The tax is paid by vaccine manufacturers, and the Department of Treasury collects the tax and manages the funds (HRSA 2025a). The CICP fund comes through Congressional appropriations to the HHS Department and is operated by the HRSA. While the federal excise tax funds the VICP, there is less information about available funds in the CICP. According to one article, if current COVID claims were compensated by CICP at a historical rate, “the program would face about $21.16 million in compensation outlays, 4.8 times its current balance of $4.41 million” without including administrative costs (Zhao et al. 2022, pp. 1–31). When the COVID-19 outbreak began in March of 2020, the Secretary for Health and Human services issued the PREP Act declaration required to trigger its immunity provisions (Meintjes 2021, p. 115). In accordance with the PREP Act, Congress then allowed the appropriation of nearly $30 billion to respond to COVID-19, including funding for the CICP. The CICP however requires “compelling reliable valid medical and scientific evidence” to prove causation of an injury. It has a one-year statute of limitations and limits the types of compensation offered. Aside from tort immunity protection, we must consider whether the HRSA can cover the costs of claims made under the CICP for COVID vaccines.

Table 1. Comparison of VICP and CICP.

Feature	VICP (Vaccine Injury Compensation Program)	CICP (Countermeasures Injury Compensation Program)
Created by	National Childhood Vaccine Injury Act (1986) 1	Congress, 2009 (via PREP Act) 2
Administered by	US Department of Justice & Court of Federal Claims	HHS (via HRSA medical review process)
Funding Source	$0.75 excise tax per vaccine dose (paid by manufacturers)	Congressional appropriations (variable)
Covers	CDC-recommended routine vaccines	Emergency countermeasures (e.g., COVID-19 vaccines)
which Vaccines?
Right to Appeal?	Yes	No
Legal Process	Formal court hearing; right to counsel	Administrative form submission only
Burden of Proof	“Preponderance of evidence”	“Compelling reliable medical and scientific evidence”
Compensation Scope	Broader (covers lost wages, pain,	Narrower (limited categories, no legal fees)
	suffering, legal fees)
Vaccine Injury Table?	Yes	No
Success Rate	~40% of petitions result in compensation	~10% of claims compensated
COVID-19	Not yet	Yes (currently active)
Vaccine Coverage?

¹ H.R.5184—99th Congress (1985–1986): National Childhood Vaccine Injury Act of 1986. Available online: https://www.congress.gov/bill/99th-congress/house-bill/5184 (accessed on 30 March 2025). ² Public Law 109–148, div C, 119 Stat. 2818 (2005): Public Readiness and Emergency Preparedness Act. Last Modified December 2024. Available online: https://www.congress.gov/bill/109th-congress/house-bill/2863/text?s=1&r=1&q=%7B%22search%22%3A%22cite%3APL109-148%22%7D (accessed on 30 March 2025).

provides a visual representation of the differences between these two programs.

Some argue that the VICP is the better vehicle for compensating individuals who are harmed as the result of a COVID-19 vaccine (Reiss 2022). Consider the following comparison of efficiency. Since 1988, the VICP has received 28,595 petitions for compensation, of which 11,925 have received compensation and 12,996 have been dismissed (HRSA 2025c). The total petitioner award amount to date minus legal costs is $4,832,258,380.22. In contrast, as of 1 June 2025, 13,836 COVID-19 vaccination claims had been filed with the CICP (HRSA 2025b). Of those, the CICP has rendered decisions in 4413 cases, and only 79 were eligible for compensation. Additionally, almost 10,000 are awaiting a review, and over 4000 have been denied (HRSA 2025b). If history is an indicator, few of those pending claims will be successful. Approximately 90% of claims to the CICP are rejected, and there is no right to appeal the decision of the HRSA (Chahede 2021–2022, p. 21). It should also be noted that claims can be denied for procedural flaws. A 2025 report by the Government Accountability Office found that 56% of claims to the CICP were ineligible for compensation due to missing a filing deadline (U.S. Government Accountability Office 2024). A claimant’s recourse for denial is to submit a written request to HRSA stating reasons for reconsideration within 60 calendar days of the original decision.2

There is some movement within Congress for change. Since COVID vaccines have not been added to the VICP, COVID vaccine manufacturers have not paid the excise tax. The Vaccine Access Improvement Act was introduced in the House and would have automatically imposed the $0.75 excise tax on vaccine manufacturers any time HHS adds a vaccine to the VICP Injury Table (Shaw 2023). It would also have added COVID-19 vaccines to the Vaccine Injury Table. The bill did not make it out of committee review (Congress.gov 2023). In 2024, Congressman Chip Roy introduced the Let Injured Americans Be Legally Empowered Act (LIABLE), a bill that would allow injured people to sue COVID-19 vaccine manufacturers for any losses their vaccines caused, eliminating tort immunity. It died in committee; however, he re-introduced the bill in February of 2025 (Roy 2025).

5. Comparative Law

Globally, vaccine immunity policies can incentivize vaccine manufacturing, stimulate R&D, and ensure supply stability by significantly reducing the unpredictable legal and financial risks that may otherwise deter private companies. About 25 other countries have taken this approach to encouraging pharmaceutical companies to develop vaccines, primarily in high income countries (Mungwira et al. 2020). Most of these countries have programs which are funded by governments and not vaccine manufacturers. Canada and Australia first established no-fault systems for vaccine injury in 2021, post-COVID, to compensate for serious injuries. The United Kingdom, France and New Zealand established government funded programs in the 1970s, which provide compensation for serious adverse events or treatment injuries. Singapore has a vaccine injury program for COVID vaccines, but it is more of a contractual-governmental immunity and not written into the law. Other countries have vaccine compensation programs but still allow civil claims to be filed. One interesting country to consider is India. It played a large role in developing COVID vaccines like Oxford–AstraZeneca’s Covishield vaccine and Novavax’s Covovax. At the height of the pandemic, India was producing over 100 million doses per month. However, it has no formal tort immunity system for vaccines. Finland, Sweden, and Norway have vaccine compensation programs funded by the insurance companies (Mungwira et al. 2020). Among major countries, Japan has a system which is funded similarly to the U.S. in that manufacturers pay a levy to a national injury pool which covers injuries from routine and temporary vaccinations (Fujiwara et al. 2021).

These programs represent a deliberate, societal decision to internalize some of the rare, unavoidable costs of vaccination through public or private funds. This acknowledges that the collective benefits of widespread immunization far outweigh these concentrated individual costs.

6. Ethical Perspective

In the NCVIA, tort immunity is intended to serve the goal of public health, and it is accompanied by the VICP. Michelle M. Mello explains the reasons for compensation programs like the VICP, distinguishing between utilitarian and nonconsequentialist arguments. On the utilitarian side, she identifies two aims: (1) to increase voluntary vaccination rates and (2) to encourage vaccine production (Mello 2008, pp. 35–36). First, she says people may be more likely to get vaccinated if they know that compensation for possible injuries is available. Second, she explains that vaccine manufacturers may be more motivated to produce vaccines, knowing that they will not have to bear the liability costs (Mello 2008, pp. 35–36).

On the nonconsequentialist side, she identifies five aims: (1) to be fair to those subject to coercion, (2) to be fair to those with professional obligations, (3) to be fair to those who act against self-interest, (4) to express solidarity, and (5) to make up for the absence of informed consent (Mello 2008, pp. 36–40). In the above order, she says first that it is in accord with the principle of fairness to offer restitution to those who are harmed as a result of being coerced to do something. Coercion may be justified, especially in the domain of public health, but when it results in unintended, but not entirely unforeseen, harm, victims should be compensated (Mello 2008, pp. 36–37). Second, she says it is fair to offer compensation to health professionals who are harmed by a vaccine that their employer requires. This is already done in other service areas, such as with injured soldiers and police officers. In the same way, health professionals take risks with their lives for the welfare of society, so they should be compensated by society when their service results in injury (Mello 2008, pp. 37–38). Third, it is fair to compensate those injured by a vaccine that was not in their interest to take in the first place. For example, in the United States, the risk of contracting polio is very low, so an individual could make an argument for remaining unvaccinated on the grounds of self-interest, but the low occurrence of the disease in the United States is due to high vaccination rates and herd immunity, those who get vaccinated for the sake of others. Those who contribute to society’s herd immunity should be compensated if injured (Mello 2008, pp. 38–39). Fourth, it is in accord with the principle of solidarity to stand with members of the community who suffer vaccine injuries whether the vaccines were voluntarily taken or not. She writes, “The injured and uninjured pay unequal shares of the social cost of producing the shared good of herd immunity. In other words, the uninjured are (unintentionally) free-riding on the injured…Fairness and solidarity both militate in favour of a safety net for those whose sacrifice is especially large” (Mello 2008, pp. 39–40). Finally, she says that with new or emergency vaccines, there may not be enough information provided to support informed consent. If such vaccines are mandated anyway, then it is morally required to compensate victims of injury for forcing them to take an uninformed risk (Mello 2008, p. 40).

7. Conclusions

Tort immunity is provided to manufacturers of vaccines to incentivize them to develop and produce vaccines and other countermeasures (Chahede 2021–2022, p. 20). Vaccines are not guaranteed money makers for pharmaceutical manufacturers, so they have little incentive to make them without protections from liability and patent guarantees. In fact, some manufacturers withdrew from vaccine production in the 1980s due to the threat of litigation (Meissner et al. 2019). During the global COVID pandemic, some vaccine manufacturers were slow in distributing COVID vaccines to low- and middle-income countries. To address this issue, the World Health Organization, through its COVAX initiative, launched a no-fault compensation program to incentivize companies to distribute the vaccines more widely. The program was funded by donors, advanced economies, and vaccine manufacturers and provides immunity for five years after injection (Sternstein 2023, pp. 72–88). This move was sufficient to induce vaccine manufacturers to participate, demonstrating the effectiveness of tort immunity guarantees.

Governments should also take steps to ensure public health and safety for vaccines. To that end, the Trump administration’s FDA has announced it will now require new clinical trials for approval of annual COVID-19 booster shots (Erman 2025). For context, the mumps vaccine took four years to develop, while Pfizer’s COVID vaccine was developed and cleared for use in eight months (Chahede 2021–2022, p. 23). While this is a move in the right direction, it would undoubtedly impact the profits of a sector that made $90 billion on their COVID vaccines in 2021 and 2022 (de Haan 2023).

The HRSA is considering a funding model for the CICP much like the VICP, which would allow it collect excise taxes for injury compensation instead of relying on appropriations (U.S. Government Accountability Office 2024). Such a move would be beneficial for claimants; alternatively, Congress and HHS should move to classify all COVID vaccines under the VICP as introduced in the Vaccine Access Improvement Act. COVID vaccine manufacturers have already escaped paying the $0.75 excise tax on the hundreds of millions of doses that have been administered in the United States. This simple classification could have added about $150,000,000 to the VICP. Before claims for COVID vaccines are classified under the VICP, more resources to the VICP office must be deployed. Both the VICP and CICP office are currently backlogged and understaffed. The backlog of cases at the VICP is more than two years long, even though the process was designed to be more efficient than litigation (Gardner 2022). Nonetheless, a reclassification of COVID vaccine injuries to the VICP would allow injured persons to file their claims in court, receive more due process for their injury claims, and have access to a wider range of compensation. Vaccine manufacturers would be taxed, those excise tax funds would be available to meet the needs of their injuries, and pharmaceutical companies would still benefit from tort immunity.

This reclassification would meet both utilitarian and nonconsequentialist objectives discussed above, but it is not necessarily how pharmaceutical companies behave in the market. Some would argue that pharmaceutical companies which make COVID vaccines should be subject to the civil tort liability system. This would encourage companies to take precautions through economic incentives like litigation rather than administrative agency actions and regulations (Lytton 2022, pp. 417–26). We disagree with calls to abolish all tort immunity for vaccine manufacturers, such as the LIABLE Act pending in the U.S. House of Representatives. As we have argued above, this could ultimately endanger public health by disincentivizing the production of vaccines. However, other reforms may be coming. HHS Secretary Robert F. Kennedy, Jr. has vowed to reform the VICP program. He said, “I will not allow the VICP to continue to ignore its mandate and fail its mission of quickly and fairly compensating vaccine-injured individuals” (Bohn 2025).

Government policy should be mindful of balancing the needs of the public with the needs of pharmaceutical companies to recoup costs and reap at least reasonable profits. This balancing act has become particularly difficult given the limited drug options available during the COVID pandemic; however, the legal and ethical discussions presented herein can provide some guidance in dealing with these difficult issues. In conclusion, relying solely on traditional tort law can undermine the public health goal of ensuring a stable and innovative vaccine supply. The market, left to its own devices, will undersupply public goods like vaccines when faced with disproportionate and unpredictable risks. In addition, adding COVID vaccines to the VICP would expedite due process for injured persons.