Comparing the Lack of Accountability Involving Vaccine Injuries—Global Review

National Vaccine Injury Compensation Program

Vaccine Makers Face Growing Pressure Over Injury Claims as New Development Continues

Global pharmaceutical companies are encountering increased scrutiny over vaccine injury compensation even as they push forward with next-generation COVID-19 vaccine development. Recent data shows manufacturers have approved less than 1% of injury claims while reporting record profits from vaccine sales.

In the United States, the federal Countermeasures Injury Compensation Program (CICP) has approved only 50 claims out of approximately 13,000 filed, according to government statistics released this month. Meanwhile, Pfizer reported over $81 billion in vaccine-related revenue for 2021 alone.

"The current system fails to balance corporate protections with individual rights," says Mae C. Quinn, Professor of Law at Penn State University. Quinn's recent analysis of global vaccine injury programs found that most countries' compensation systems remain "overwhelmed by backlogs" and provide "problematic" levels of support.

Legal challenges are mounting. The Kansas Attorney General filed suit against Pfizer in June 2024, alleging the company misled the public about vaccine risks. In Australia, a class action representing over 500 people is proceeding against government health officials for alleged negligence in vaccine approval processes.

Some countries have taken a different approach. Canada's injury support program has approved 183 claims and provided over 14 million Canadian dollars in compensation. The United Kingdom allows individuals to pursue both administrative claims and court litigation.

Vaccine manufacturers defend their protected status as necessary for rapid pandemic response. However, advocacy groups argue that record profits should correspond with greater accountability. Proposed legislation in multiple countries seeks to reform compensation systems while maintaining incentives for vaccine development.

As pharmaceutical companies continue work on updated boosters and variant-specific vaccines, the debate over balancing innovation with responsibility shows no signs of subsiding. Industry analysts expect this issue to significantly impact future vaccine development agreements between governments and manufacturers. 

Legal Framework for Vaccines

Here is the key legal framework governing COVID-19 vaccines and injury claims:

Federal Law:

• - Public Readiness and Emergency Preparedness (PREP) Act of 2006 provides broad immunity to vaccine manufacturers from liability
• - Claims must go through Countermeasures Injury Compensation Program (CICP) rather than courts
• - Requires proof of direct causal link between vaccine and injury
• - One-year filing deadline from vaccination date
• - No attorney fees covered
• - Limited to actual medical costs and lost wages

State Law:

• - States generally cannot override PREP Act protections
• - Some states have additional vaccine requirements/exemptions
• - State courts largely barred from hearing vaccine injury cases

Notable Exceptions:

• - Willful misconduct claims can proceed in court
• - Clinical trial participants may have additional contractual rights
• - Veterans/military personnel may have separate remedies
• - Workers' compensation may cover workplace-mandated vaccines

Current Legal Challenges:

• - Constitutional challenges to CICP procedures
• - State AG lawsuits over marketing claims
• - Class actions targeting government approvals
• - Efforts to reform compensation system through legislation

Key Differences from Regular Vaccine Claims:

• - Standard vaccine injuries go through separate Vaccine Injury Compensation Program (VICP)
• - VICP allows court review and attorney fees
• - Longer filing deadlines
• - More established causation standards
• - Higher compensation rates

This special legal framework remains controversial given manufacturer profits and low compensation rates through CICP.

Global Variation

Global vaccine injury compensation systems vary significantly across jurisdictions:

Key Legal Frameworks:

1. No-Fault Systems (Canada, UK, Nordic countries)
- Administrative claims process
- Compensation without proving manufacturer fault
- Often allows parallel court litigation

2. Manufacturer Immunity Systems (US, Australia, South Africa)
- Legal protection for vaccine makers
- Government-administered compensation programs
- Limited or no access to courts

3. Mixed Systems (Various EU countries)
- Combination of administrative claims and legal options
- Varying degrees of manufacturer protection
- Different compensation standards

WHO's Role:

1. COVAX Program

• - Coordinates global vaccine distribution
• - Manages no-fault compensation scheme for 92 low-income countries
• - Sets compensation based on country GDP
• - Processes claims through insurance partner Chubb

2. Policy Guidance

• - Issues vaccine safety recommendations
• - Provides compensation system frameworks
• - Coordinates international response
• - Monitors adverse events

3. Standard Setting

• - Develops vaccine quality standards
• - Reviews safety data
• - Issues emergency use listings
• - Coordinates reporting systems

Current Trends:

• - Growing pressure for manufacturer accountability
• - Push for more equitable global compensation
• - Calls for standardized international framework
• - Emphasis on transparency and access

The system remains fragmented, with significant disparities between wealthy and developing nations in both access to vaccines and compensation for injuries.

Legal requirements for vaccine trial data transparency

Legal requirements for vaccine trial data transparency vary by jurisdiction, but key requirements include:

FDA (United States):

• - Registration of trials on ClinicalTrials.gov
• - Submission of complete clinical study reports
• - Safety and efficacy data from all trial phases
• - Regular safety updates during trials
• - Disclosure of adverse events
• - Public access to summary results within 12 months

EMA (European Union):

• - Registration in EU Clinical Trials Register
• - Publication of trial protocols
• - Mandatory reporting of all results
• - Public access to clinical study reports
• - Disclosure of safety monitoring data
• - Release of anonymized individual patient data

WHO Requirements:

• - Registration in approved registry
• - Reporting of trial results
• - Safety monitoring protocols
• - Public disclosure of protocol changes
• - Sharing of efficacy data
• - Publication of final study reports

COVID-19 Modified Standards:

• - Expedited review processes
• - Rolling submissions allowed
• - Reduced timeframes for data release
• - Emergency use authorizations
• - Continued post-market surveillance
• - Real-world evidence requirements

Notable gaps:

• - Limited requirements for raw data release
• - Varying standards for independent analysis
• - Incomplete access to manufacturing data
• - Protected commercial information
• - Inconsistent global enforcement
• - Limited penalty mechanisms

The pandemic highlighted tensions between rapid deployment and comprehensive data transparency, with some arguing current requirements insufficiently protect public interests.

Comparing the Lack of Accountability Involving Vaccine Injuries—Global Review

trialsitenews

 Staff at TrialSite | Quality Journalism

Jan. 2, 2025, 7:30 a.m.

The COVID-19 pandemic introduced uncertainty and fear, as vaccines were rapidly developed and deployed worldwide. While vaccines offered hope, little was shared about potential risks or how injuries would be addressed. In many countries, including the United States, vaccine manufacturers were granted immunity from traditional lawsuits, with compensation claims handled through specialized no-fault systems. These systems have faced widespread criticism for lack of transparency, inadequate compensation, and bureaucratic hurdles.

A recent article by Lailatul-Mubarakah Imam Aliagan of the University of Iowa College of Law and Mae C. Quinn, Professor of Law at Penn State University, published in the Penn State Law Review, examines the origins and implications of these frameworks. The authors argue that these systems unfairly shield vaccine manufacturers, who have profited immensely, while injured individuals struggle for justice. They call for reforms to balance public health priorities with individual rights.

In the U.S., the Countermeasures Injury Compensation Program (CICP) has processed roughly 13,000 COVID-19 vaccine claims but approved only a handful, citing stringent criteria and low payouts. Similarly, Australia’s no-fault scheme has compensated just 3% of claims, and South Africa’s program has distributed minimal funds. By contrast, the UK's Vaccine Damage Payment program allows claimants to pursue lawsuits and offers lump-sum payments, though its compensation limits are outdated. Canada’s Vaccine Injury Support Program has approved 183 claims out of 2,600 but faces scrutiny for delays and unclear award criteria.

Grassroots activism has emerged in response to these shortcomings. Organizations like React19 in the U.S. have stepped in to provide financial support for injured individuals, raising more funds than government programs. Globally, advocacy groups have pushed for reforms, including the U.S. Vaccine Injury Modernization Compensation Act and similar proposals in the UK Parliament. Legal challenges are also underway, such as Kansas’s lawsuit against Pfizer for alleged false advertising and Australia’s class action cases targeting government negligence.

The political implications are significant. Frustration with vaccine mandates and compensation systems, not to mention state overreach during the COVID-19 pandemic likely contributed to Donald Trump’s victory in the 2024 U.S. presidential election. His administration’s nomination of Robert F. Kennedy Jr., a critic of corporate health systems, as Health and Human Services Secretary signals potential reforms.

The tension between rapid vaccine rollout and equitable systems for addressing injuries remains clear. Proposals for change include shifting claims to more transparent systems like the U.S. Vaccine Injury Compensation Program (VICP), enhancing global equity in compensation, and urging manufacturers to contribute to robust relief funds. More far-reaching advocates seek to reverse any liability protections. Advocacy and grassroots efforts emphasize the need for accountability, fairness, and transparency to restore trust in public health systems and deliver justice to those harmed.

Source: Penn State Law Review