Trial participants' rights after authorisation of COVID-19 vaccines

• Authors: Rafael Dal-Re, Universidad Autónoma de Madrid; Walter Orenstein, Emory University; Arthur L Caplan, New York University
• Journal Title: LANCET RESPIRATORY MEDICINE
• Volume: Volume 9, Number 4
• Publisher: ELSEVIER SCI LTD | 2021-03-30, Pages E30-E31
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1016/S2213-2600(21)00044-8
• Subjects: Health Sciences, Epidemiology; Health Sciences, Public Health
• Keywords: Science & Technology; Life Sciences & Biomedicine; Critical Care Medicine; Respiratory System; General & Internal Medicine

Abstract

Many countries are deploying COVID-19 vaccines under temporary authorisations (ie, emergency use authorisation in the USA, conditional approval in the EU, and emergency use listing by WHO). A WHO expert group provided ethical reasons supporting their proposal to maintain as long as possible large placebo-controlled randomised trials.1 Although gathering long-term (≤27 months) safety and efficacy data is scientifically important, it will be impossible to achieve with the original trial designs. Once a vaccine is available, participants who received the placebo must have access to the available vaccine, as do all other citizens