No-fault Vaccine Injury Compensation Systems Adopted Pursuant to the Covid-19 Public Health Emergency Response

• Jurisdiction: United States,Federal
• Citation: Vol. 37 No. 1
• Publication year: 2022
• topic: Administrative Law,Insurance Law,Health Law,Civil Procedure,Public Sector Law,Workers Compensation

No-Fault Vaccine Injury Compensation Systems Adopted Pursuant to the COVID-19 Public Health Emergency Response

Sam Halabi

Katherine Ginsbach

Katie Gottschalk

John Monahan

Judith Murungi

NO-FAULT VACCINE INJURY COMPENSATION SYSTEMS ADOPTED PURSUANT TO THE COVID-19 PUBLIC HEALTH EMERGENCY RESPONSE

Sam Halabi^*

Katherine Ginsbach^**

Katie Gottschalk^***

John Monahan^****

Judith Murungi^*****

Abstract

No-fault vaccine injury compensation systems have developed over the course of the twentieth century, mostly in the richest countries in the world. Acknowledging that severe reactions to vaccines are rare, but can result in serious and sometimes complex injury, these systems provide financial and social support for those suffering these rare side effects. During the COVID-19 pandemic, and the rapid development and deployment of vaccines using novel technologies, these systems have proliferated not only among wealthy countries, where in their modern form they originated and spread, but also low- and middle-income ones. Adopting varying approaches to funding, eligibility, administration, process, and components of compensation and rights of appeal, these new systems offer protections to populations in low- and middle-income countries that until 2020 covered only those in relatively wealthy states,

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especially Europe and North America. The purpose of this Article is twofold. First, it provides the first comprehensive landscape analysis of no-fault vaccine injury compensation systems since before the COVID-19 pandemic. That analysis identifies twenty-five such systems, almost all of which were established for routine immunizations. Second, it provides an accessible resource for advocates and planners in low- and middle-income countries that may benefit from an analysis of administrative, funding, eligibility, and compensation alternatives that they may consult when considering whether and how to construct their own no-fault vaccine injury compensation systems.

Table of Contents

I. Introduction.................................................................................57

A. Side Effects of COVID-19 Vaccines........................................... 58
B. The History and Purpose of No-Fault Vaccine Compensation Systems to Address Severe Side Effects...................................... 61

1. No-Fault Compensation Systems for Routine Immunizations..................................................................... 63
2. No-Fault Compensation Systems for Emergency Immunizations.....................................................................65
3. Global No-Fault Injury Compensation Systems ................... 70

II. Materials and Methods..............................................................73
III. Analysis.........................................................................................75

A. Establishment, Administration, and Funding of No-Fault Vaccine Injury Compensation Systems ................................................... 76

1. Administration .................................................................... 77
2. Funding.............................................................................. 79

B. Eligibility..................................................................................80

1. Approved Vaccines ............................................................. 80
2. Timelines of Injury and Vaccination .................................... 82
3. Injured Party ...................................................................... 83
4. Types of Injury Covered...................................................... 83

C. Process, Decision making and Standard of Proof...................... 85
D. Elements of Compensation ........................................................ 87
E. litigation Rights ....................................................................... 88
F. Next Steps................................................................................. 89

IV. Conclusion....................................................................................90

Appendix...................................................................................................91

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I. Introduction

Vaccines are the quintessential public health intervention for preventing the spread of infectious disease and, as a result, the highest public health priority in the world is deploying a safe and effective vaccine against COVID-19.¹ As of August 31, 2022, twelve vaccines have been approved for emergency or conditional use; twenty-one vaccines have been authorized for early or limited use; and one hundred twenty-three vaccines are currently being testing in clinical trials, with forty-two at Phase III.² COVID-19 vaccines currently in use have clearly prevented serious illness, and now the evidence is growing that they reduce transmission.³ A recent analysis suggests a single dose of either Pfizer's or AstraZeneca's COVID-19 vaccine reduces the risk of transmitting SARS-CoV-2 by as much as half.⁴ The end of the COVID-19 pandemic will depend on global access to vaccines.⁵

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A. Side Effects of COVID-19 Vaccines

Yet, like nearly all vaccines, COVID-19 vaccines generate rare, serious side effects ranging from soreness at the injection site to fever and muscle pain to, exceptionally, anaphylaxis and other severe reactions.⁶ For all vaccines, these events are rare: less than one severe adverse event occurs per ten million doses for tetanus toxoid vaccines and between one to two severe adverse events per one million doses for inactivated influenza vaccine.⁷ Yet the injuries resulting from serious adverse events following immunization (SAEFI) can be complex and in some cases require lifelong care.⁸

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COVID-19 vaccines are no exception. In March 2021, after more than twenty-five million people received at least one dose of AstraZeneca's ChAdOxl nCoV-19 vaccine, twenty countries paused vaccinations after reports of patients experiencing clotting disorders and rare types of strokes.⁹ The European Medicines Agency (EMA) safely committee undertook a review of sixty-two cases of cerebral venous sinus thrombosis and twenty-four cases of splanchnic vein thrombosis, eighteen of which were fatal.¹⁰ On April 7, 2021, the EMA concluded that unusual blood clots with low blood platelets should be listed as a very rare side effect.¹¹ As of this writing, the risk of death from

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thrombosis with thrombocytopenia syndrome (TTS) following immunization with AstraZeneca's Vaxzevria vaccine is approximately 1.6 in one million.¹²

In the United States, administration of the Janssen (a unit of Johnson & Johnson) COVID-19 vaccine was paused after reports of six cases of a rare and severe type of blood clot in individuals.¹³ After analysis of data drawn from 6.8 million administrations, the CDC found the risk of thrombosis with thrombocytopenia syndrome at a rate of seven per one million vaccinated women between eighteen and forty-nine years old.¹⁴ As of March 18, 2022, out of more than eighteen million people who received the Janssen vaccine, sixty cases of TTS were reported and nine people died.¹⁵ On May 5, 2022, the U.S. Food and Drug Administration limited approval of the vaccine in the United States to individuals eighteen and older for whom the other authorized or

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approved vaccines "are not accessible or clinically appropriate," or who choose to receive it because they would otherwise not receive a vaccine.¹⁶

As of August 2021, more than 1,600 cases of myocarditis or pericarditis had been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS), after hundreds of millions of mRNA (Pfizer and Moderna) vaccine doses were administered.¹⁷ The evidence to date suggests that the risk of myocarditis after receiving mRNA-based COVID-19 vaccines increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men.¹⁸

B. The History and Purpose of No-Fault Vaccine Compensation Systems as a Mechanism for Addressing Severe Side Effects

The relationship between immunization's critical role for public health on the one hand, and, on the other, the small number of individuals suffering SAEFI poses an ethical and practical dilemma.¹⁹ Leaving those individuals and their

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families to bear the costs of their injuries would mean that the community would benefit from these individuals' contributions to herd immunity, leaving the uninjured to receive a health benefit at the cost of the injured.²⁰ Second, without such a system, those suffering SAEFI may, and often must, resort to litigation against vaccine manufacturers based on theories that manufacturers of products, who gain financially from their sale, should also be responsible for the costs they impose.²¹ The potential cost of liabilities for injuries or death deters manufacturers from selling to countries where they perceive the risks are too high.²²

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No-fault vaccine injury compensation systems provide one answer to this dilemma.²³ No-fault vaccine injury compensation systems provide a mechanism, funded and administered in various ways, to make those injured by vaccines, or their families, whole.²⁴ Relatedly, because these systems provide exclusive and predictable channels of recourse, manufacturers can effectively manage the potential cost of liabilities.²⁵

1. No-Fault Compensation Systems for Routine Immunizations

Because no-fault vaccine injury compensation systems provide this mutual advantage, they have steadily proliferated since the legal principle justifying them was established in 1953.²⁶ In that year, "the German Supreme Court ruled that people who were injured by compulsory vaccination (in this case smallpox) were entitled to compensation. Germany enacted a compensation programme in 1961."²⁷ In the 1970s, concerns over side effects related to the diphtheria-tetanus-pertussis vaccination—a combined childhood...