AstraZeneca Plc has suspended a final-stage trial of one of the leading Covid-19 vaccine candidates, after a suspected serious adverse reaction on one of the participants.
This was disclosed by a health news website, Stat News, on Tuesday, September 8, 2020, while quoting an AstraZeneca spokesperson.
The AstraZeneca official said, “Standard review process triggered a pause to vaccination to allow the review of safety data.”
AstraZeneca, in a statement, said that the trial was put on hold to conduct a standard review of the drugmaker’s vaccine trials after one person developed an unexplained illness. The pharmaceutical company said that this was intended to give researchers time to examine safety data while maintaining the integrity of the trials
This study is testing a Covid-19 vaccine which is being developed by AstraZeneca in collaboration with University of Oxford researchers at various sites, including the United Kingdom, where this adverse reaction was reported.
The media report suggests that although the participant is expected to recover, details of the nature of the case and when it happened were not given.
Stat news said that the suspension of the trial has affected other vaccine trials by AstraZeneca as well as clinical trials being conducted by other vaccine makers, who are looking for signs of similar reactions.
The AstraZeneca spokesperson’s statement reads, “In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.”
Stat News reported that serious adverse reactions from the trials could have various outcomes such as issues that require hospitalization, life-threatening illness and death.
It can be recalled that 9 leading US and European vaccine developers, which include AstraZeneca, Pfizer Inc and GlaxoSmithKline, pledged on Tuesday to ensure scientific safety and efficacy standards for their vaccine candidates despite the alleged political pressure and urgency to contain the coronavirus pandemic.