Congress Should Enact No-Fault Compensation for COVID-19 Vaccine Injuries

By Dorit Rubinstein Reiss

If COVID-19 vaccines lead to any serious harms, society should compensate those victims generously and quickly.

Currently, under the Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers and providers are immune from liability.

Anyone seeking compensation for a severe side effect from a COVID-19 vaccine needs to go through a government program that is extremely narrow and hard to win; the Countermeasures Injury Compensation Program (CICP). The program requires “compelling, reliable, valid, medical and scientific evidence” to be compensated — a very high bar. It has compensated only a very small percentage of claims submitted over the years.

But we have an alternative. The Vaccine Injury Compensation Program (VICP) provides compensation under a much more generous standard. It has been used for years for childhood vaccines, and has served us well. While not perfect, it offers a decent path forward.

To allow people claiming harms from COVID-19 vaccines to reach VICP, however, Congressional action is needed. Congress needs to include COVID-19 vaccines in the program, and attach a small excise tax — a tax on each dose — to cover compensation.

Congress should do that.

Vaccines save lives. COVID-19 has killed hundreds of thousands in the United States and harmed many more; naturally, we are excited to get COVID-19 vaccines. But nothing is completely risk-free.

While current data suggests the mRNA vaccines against COVID-19 are very safe, that data is limited to the tens of thousands of participants in the clinical trials. It is possible that we will discover that COVID-19 mRNA vaccines, or other COVID-19 vaccines, have serious side effects that occur much less frequently — affecting one in 100,000, one in a million, or less.

This will not change the risk/benefit balance of COVID-19 vaccines; they will still carry less risk than contracting the disease itself, and absolutely safe: a risk of one in a million is very small. But it is not zero, and those who suffer deserve compensation.

Normally, if you are harmed by a pharmaceutical product, you have to show that there is cause to impose liability on the manufacturer. You have to show that the product was defective, or that the manufacturer acted negligently (or worse), or you will not be compensated.

If you take antibiotics and have a rare allergic reaction, you usually have no claim, unless you can show the manufacturer did not warn of the possibility, or acted negligently, or fraudulently, or the product was generally unsafe.

For emergency products, we add another layer of difficulty to imposing liability. The PREP Act allows the Secretary of Health and Human Services to protect manufacturers from liability for products produced during a public health emergency. The logic is that manufacturers will not make products fast enough without this protection, because they will be concerned about undiscovered risks.

But vaccines are different than other products.

When you get vaccinated, you protect not only yourself, but also others who you might have otherwise infected if not immune. We hope COVID-19 vaccines will lead to herd immunity. Though we do not have good data on whether they will prevent infection, we have good cause to hope that they will. So people who are getting them are not just protecting themselves, but protecting others — and society.

When you take a vaccine, and contribute to a public good, society owes you a debt. If the vaccine hurts you, the just result is for society to pay for your harms, whether or not the manufacturer was at fault. It is simply unjust that one person would bear the cost, when society as a whole reaps the benefits.

This logic is why nineteen countries, including the United States, have no-fault compensation programs for vaccines. While our path to this program involved a crisis where extensive litigation, most of it ill-founded, caused vaccine manufacturers to leave the market, and required Congress to step in to protect the supply, the underlying justification is still there. This same justification undergirds scholars’ call for a global no-fault compensation program for COVID-19 vaccine injuries.

Conquering COVID-19 is a public good. In the event that COVID-19 vaccines lead to injury, those victims should be compensated of the debt owed to them by society. VCIP provides an opportunity for such compensation.