How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine
Saad Shakir, Samantha Lane, Miranda Davies
Abstract
There is an urgent need for the development of a safe and effective vaccine for COVID-19. As such, COVID-19 vaccine candidates have been developed at unprecedented speed, and there are currently a handful of vaccines in the final stages of clinical testing. It is of critical importance that the normal evaluation of safety is not reduced or compromised in any way because of high-speed clinical development. UK trials of the Oxford and AstraZeneca vaccine have resumed after a brief pause, following safety concerns. A statement made by AstraZeneca on 12 September stated that “on 6th September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.” A press release published on the AstraZeneca website on 2 October, 2020 confirmed that the trial had not yet been resumed in the USA [1]. AstraZeneca and the University of Oxford have not disclosed details of this case. More recently, on the 13 October, 2020, Johnson & Johnson reported that further dosing in the phase III ENSEMBLE COVID-19 vaccine trial had been paused, owing to an unexplained illness in a study participant [2]. In this editorial, we describe how serious adverse events reported in a vaccine clinical trial should be investigated by reviewers [regulators or members of the Data and Safety Monitoring Board (DSMB)] to assess whether a causal relationship exists.