Setback In Race For COVID Vaccine As Oxford-AstraZeneca Halts Trial After Unexplained Illness
At a time when the world is desperately waiting for the COVID-19 vaccine to arrive, the process has hit an unexpected hurdle after UK-based AstraZeneca halted its trials.
The development came on Tuesday after concerns were raised about the safety of the vaccine following reports of an unexplained illness of a participant.
AstraZeneca Plc said it has paused global trials, including large late-stage trials, of its experimental coronavirus vaccine due to an unexplained illness in a study participant.
Vaccine hits a roadblock
The vaccine, developed with the University of Oxford, has been described by the World Health Organization as probably the world's leading candidate and the most advanced in terms of development.?
The suspension dims prospects for an early rollout amid reports that the United States was aiming for a fast-track approval before the November presidential election.
The British drugmaker said it voluntarily paused trials to allow an independent committee to review safety data, and it was working to expedite the review to minimise any potential impact on the trial timeline.
Company to review status soon
"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials," the company said in an emailed statement.
The nature of the illness was not disclosed, although the participant is expected to recover, according to Stat News, which first reported the suspension due to a "suspected serious adverse reaction".
The US Food and Drug Administration defines an adverse event as one in which evidence suggests a possible relationship to the drug being tested.
According to a New York Times report which cited a person familiar with the situation, a participant based in the United Kingdom was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.
AstraZeneca only began its Phase 3 trial in the US in late August
The US trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the UK, Brazil, and South Africa.
The phase-3 human trials of the?Oxford-AstraZeneca vaccine?(which will be called?Covishield?in India) was also underway in India since last month.
Pune-based Serum Institute of India has partnered with AstraZeneca for manufacturing the COVID-19 vaccine.
The trials of Covishield vaccine involved 1,600 people above the age of 18 years across 17 locations in Pune, Mumbai and Ahmedabad.
