COVID-19 Vaccines and their Pitfalls in Informed Consent

COVID-19 Vaccines and their Pitfalls in Informed Consent
Yousef Haik, Eleni Polymenopoulou
Hastings Science and Technology Law Journal, Summer 2021; 12(2)
The World Health Organization declared the coronavirus (COVID-19) pandemic as a global health crisis. The search for a coronavirus vaccine escalated to a global competition. Drugs for other diseases as well as new formulations are proposed as potential candidates for the treatment or intervention of coronavirus. Almost all pharmaceutically able countries are pursuing potential vaccines. At the time of writing this article, two vaccines are already marketed and tested with promising interim results. Both vaccines use messenger RNA (mRNA) encapsulated in a lipid nanocarrier. Under ordinary circumstances, clinical trial authorizations oblige sponsors to disclose all risks to volunteers in order to formulate an informed knowledgeable decision. This however has been subject to exceptions during the pandemic. The mRNA-based vaccine has been rushed in unprecedented record speed to human clinical efficacy evaluation. This raises a number of questions related to the validity of volunteers’ free and informed consent. The present article argues that informed consent of all risks as well as the protection of volunteers’ personal data constitute concrete obligations under human rights law that cannot be derogated from in times of emergency – such as the COVID-19 pandemic. Furthermore, it suggests a risk governance framework through blockchain for international vaccine testing clinical trials.

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