Anti-Coronavirus Disease 2019 Vaccines: Need for Informed Consent.

Abstract

Vaccines are among some of the most efficacious medical and public health methods ever employed to contain a pandemic, in addition to providing protective and preventive measures. Evaluation of vaccineassociated adverse events through experimentation and empirical evidence is an integral part ofthoroughly assessing the safety of vaccines before authorization of their widespread use. History has highlighted the importance of continuous search for possible vaccine-related adverse effects and vaccine-induced immunogenicity long afterlicensure, suggesting that a primary concern with new vaccines is not only efficacy but also safety, particularly overthe long term. Many of the various anti-COVID-19 vaccines have used different types of technology, with some being introduced for the first time or rushed shortly into testing, bypassing animal experimentations. They have been adopted for use through emergency use authorizations, leading to a less than optimal collection of broad data on safety, immunogenicity, effectiveness, and time span of protection, as well as short follow-up of few months, despite many infectious disease experts arguing thatit takes 10 years to develop a vaccine. Given the valid concerns on well-recognized short-term and long-term safety issues, such as antibody-dependent enhancement and other processes like molecular mimicry and potential genomic transformation, the experimental nature of the vaccination process, the limited shortterm follow-up in the main trials, and the dismissal by law of pharma companies and health care providers from any medico-legal responsibilities, the application of an informed consent should become not only a necessity but also mandatory by law in accordance with all declarations on human rights. Such information should be provided to every potential recipient in the form of an official written digital consent prior to the registration for or the receipt of the vaccine.