Unpaid Compensation for Vaccine Injury-The Other Side of Reasonable Access to Covid-19 Vaccines

The Covid-19 pandemic sparked a global vaccine race. As of September 27, 2020, there are more than 200 vaccine candidates in preclinical and clinical progress, including 11 in phase 3 trials. Wealthy governments that have invested in vaccine candidates have entered into two agreements with manufacturers that could result in saving vaccine doses for most countries with income – a phenomenon known to be “vaccine nationalism” – which could leave people in poor countries vulnerable to Covid -19.

The response to vaccine nationalism was to create the COVAX Facility, an international partnership aimed at financially supporting leading vaccine candidates and ensuring access to vaccines for lower-income countries. Seventy -nine high -income countries are members of COVAX. Their governments will help support 92 countries that cannot afford Covid-19 vaccination.

But large, major financial commitments by manufacturers are only half the solution to ensuring companies are willing to join the COVAX mechanism for vaccine delivery. It is equally important to offer protection to companies against the potential liability that Covid-19 vaccines should cause actual or perceived harm to recipients. Manufacturers do not agree to purchase contracts or ship vaccinations without liability protection. An AstraZeneca executive, for example, in the company’s bilateral contracts, provided it with protection against legal claims arising from the use of vaccine products, because it “could not risk” liability.1 As early as 2006, the International Federation of Pharmaceutical Manufacturers and Associations, the global pharmacy-industry lobbying group, publicly asked to protect manufacturers from lawsuits related to vaccine-related adverse events if they participate in pandemic responses. In the United States, the Public Preparedness and Emergency Preparedness Act grants manufacturers immunities from lawsuits related to harms caused by vaccines, with strict exceptions. People injured by Covid-19 vaccines must file claims with funding administered by the Department of Health and Human Services.

For a vaccine that is likely to be distributed around the world, there is an inevitable risk of serious adverse events, such as seizures and allergic reactions, even with a safe product. Such events may not start surfing until more people have been vaccinated. During the 2009 H1N1 influenza pandemic, the incidence of severe adverse events after vaccination varied across the country. In the United States, the Vaccine Adverse Event Reporting System receives reports of incidents in the amount of 2.45 per 100,000 doses. The corresponding surveillance system in China found that 1083 of the 8067 adverse events recorded (1.21 per 100,000 doses) were severe. Compensation costs also vary. An H1N1 vaccine with concomitant infection is associated with an increased risk of narcolepsy, resulting in multiple claims costs in Northern European countries.

For most countries, offering drug companies a fee or complete resistance from lawsuits is not constitutionally or financially feasible. Some governments refuse to make such offers because of basic principles of fairness: manufacturers must pay for damages caused to their products. For example, during the Ebola emergency in West Africa, for example, the government of one of the most affected countries refused to accept responsibility in relation to vaccines considered for shipment under emergency use permits. The difficulty for low-income countries, for example, is if they refuse to offer manufacturers protection against liability and go without Covid-19 vaccines or to expect liability protections (if possible it is constitutional) and risks that there will be many people injured for whom the government cannot provide compensation.

We believe that the solution to this problem involves using two faultless vaccine injury regimes and creating a third regime under the authority of COVAX. Countries may, of course, not choose these programs or design their own national or regional payment systems, but such systems need to be developed quickly.

First, 24 Canadian states and provinces of Quebec have fault -free vaccine injury compensation systems for routine vaccination.2 Even if these systems are not generally designed to cover the harms associated with vaccine administration during public health emergencies, they can be easily adapted to do so. Changes may be made to policies related to funding, proof of damage, and distribution of compensation. These systems are likely to exist in rich countries, but Nepal and Vietnam also have such systems. Countries with existing fault-free vaccine compensation systems may include Covid-19 vaccines in these programs.

Second, the World Health Organization (WHO) has an assurance mechanism for vaccines distributed under emergency use permits. This mechanism requires the recipient country to agree to pay WHO, donors, manufacturers, and health care workers who vaccinate people; the WHO immediately provides compensation to people with serious adverse events. The program should be small in scale, but it can be a useful option for small countries.

Even if these components are part of the answer, there must also be a mechanism for efficient management of a high number of claims from around the world. To meet this need, we believe the COVAX Facility should develop a mechanism for reimbursing people with severe adverse events after vaccination. Since COVAX will require national placement plans for vaccines, it may be possible to include countries in plans for postmarketing safety surveillance.

Scholars, economists, and representatives from international organizations have stated that it is impossible to accurately identify people who have been seriously injured, substantiate their claims, and directly provide compensation. Those with an existing claim model, however, have shown that the same claims can be processed accurately and efficiently.

Repayment funds serve many groups of people, including low -income and low -income countries. Following Iraq’s invasion of Kuwait, the United Nations created the United Nations Compensation Commission in 1991. The commission reviewed nearly 2.7 million claims and released 1.5 million awards with a combined value of more than $ 50 billion and is an early and acclaimed model for accurate and efficient processing of mass-claims.3 The Trust Fund for Victims is another viable model. The fund is created to provide support to victims of crimes committed by people convicted at the International Criminal Court. It traditionally pays more than 100,000 people a year, including those in the rural regions of the Democratic Republic of Congo, Uganda, and the Central African Republic. Consistent with health reviews, the fund makes such payments “in an effective and efficient manner.”4 These compensation systems show that it is possible to create a global, centralized commission to compensate for damages associated with Covid-19 vaccines.

Choosing to Find, Qualify, and Administer for No-Fault Compensation for Injuries Similar to Covid-19 Vaccines.

A COVAX payment system can be funded by providing produced sources from high-income countries or by charging manufacturers a tax per dose to support its purpose. Given the billions of doses of Covid-19 vaccine that may be given, a 5 or 10 cent fee per dose is enough to create a pool of resources for the fee. the table outlines the funding, qualification, and administrative aspects of this proposal.

Creating a comprehensive system for fault -free compensation of vaccine damage is feasible and will promote justice. Non-participating countries that cannot compensate for the stability or resistance strength of manufacturers could be deprived of billions of people of the protection that vaccines will provide. Allowing Covid-19 vaccines to go without ensuring that people with serious adverse events are reimbursed will benefit uninjured people at the expense of injured people.5 We believe that the worldwide community that promotes vaccination as a common interest, knowing that people will get hurt, should share the burden of the costs of this injury. In addition, manufacturers are critical to vaccine development and access and should maintain a minimum level of economic security. A global commission for compensation based on the COVAX Facility is a reasonable, feasible solution that could expedite the availability of Covid-19 vaccines while ensuring that vulnerable people are able to seek compensation for injuries, and can this will set a standard for future vaccination campaigns.

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