After a volunteer developed an unexplained illness, UK based pharmaceutical company AstraZeneca voluntarily paused a randomized clinical trial of its COVID-19 vaccine in what it called a routine action, said the company on Tuesday.
In the global race for a COVID-19 vaccine, AstraZeneca, who is co-developing the vaccine with the Oxford University, is a frontrunner.
A spokesperson said on Tuesday that they have voluntarily paused vaccination to allow the review of safety data by an independent committee, as part of the standard review process of ongoing randomized, controlled global trials of the Oxford coronavirus vaccine.
Whenever a volunteer shows potentially unexpected illness, such routine action has to happen to investigate and ensure that the integrity of the trials is maintained.
Illnesses may happen by chance in large trials, but they must be investigated independently.
The spokesperson added that they are working to accelerate the review process of this particular event of illness to minimize any potential impact on the timeline of the clinical trial.
No information is publicly available on where the patient was or the severity or nature of the illness.
Holds during clinical trials of vaccines and drugs are common, but this is for the first time clinical
trials of a COVID-19 vaccine is being paused.Currently, candidate vaccines form 9 companies worldwide are under the last-stage Phase 3 trial, and AstraZeneca is one among them.
On August 31, the company enrolled 30,000 volunteers across dozens of sites in the US for the clinical trials of the vaccine. The vaccine named AZD1222 uses a weakened version of adenovirus, causing the common cold, genetically engineered to express the spike protein used by SARS-CoV-2 to infect cells.
The vaccine produces the spike protein inside the human body and prime the immune system to protect from the SARS-CoV-2 virus in case the person is infected later.
