COVID-19 Vaccines and Informed Consent

July, 2022

Introduction

Most Americans have long assumed that they have a fundamental right to make decisions about their own bodily health and the medical treatments they receive. Informed consent is the ethical and legal principle by which that fundamental right is enforceable. To be able to give informed consent a person needs to be informed about the risks and benefits of, and alternatives to, the proposed treatment. The fundamental right to informed consent is particularly important with respect to the COVID-19 vaccines which are available in the United States pursuant to Emergency Use Authorizations (EUAs). Under the federal EUA statute, people are entitled to be informed about their right to accept or refuse administration of these vaccines, the consequences (if any) of refusing vaccination, and the benefits and risks of alternatives to the vaccines. The manufacturers of EUA vaccines, and the people and organizations administering them, are immune from liability suits. People who suffer severe adverse effects after receiving a COVID-19 vaccine will not be able to recover compensation, for their monetary and emotional distress damages, from the vaccine manufacturers or from the people who vaccinated them. Similarly, the family members of people who die after receiving a COVID-19 vaccine will not be able to recover compensation for their loss.