AstraZeneca pauses COVID-19 vaccine trial after unexplained illness
10 September, 2020
Pharmaceutical company AstraZeneca said Tuesday it had "voluntarily paused" a randomized clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness.
The business, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a COVID-19 vaccine.
"Within the ongoing randomized, manipulated global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to permit overview of safety data by an independent committee," a spokesperson said.
"This is a routine action which includes to happen whenever you will find a potentially unexplained illness in another of the trials, although it is investigated, ensuring we maintain the integrity of the trials."
It added that in large trials, illnesses will sometimes happen by chance but should be reviewed independently.
"We will work to expedite the review of the single event to minimise any potential effect on the trial timeline," the spokesperson added.
It was not immediately clear where the patient was, or the type and severity of their illness.
So far as Indian trials are worried, Serum Institute of India said that trials of AstraZeneca Plc’s COVID-19 vaccine prospect in the united states is ongoing and has not faced any issues.
Holds during clinical trials aren't uncommon, but that is thought to be the first time it has happened for a COVID-19 vaccine trial.
AstraZeneca is one of nine companies currently in late-stage Phase 3 trials because of their vaccine candidates.
In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31.
The vaccine, called AZD1222, uses a weakened version of a common cold creating adenovirus that is engineered to code for the spike protein that the novel coronavirus uses to invade cells.
After vaccination, this protein is produced inside body, which primes the immune system to attack the coronavirus if the individual is later infected.
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