AstraZeneca COVID-19 vaccine trial paused after unexplained illness

New Delhi, Sep 09: UK-headquartered biopharmaceutical giant AstraZeneca's COVID-19 vaccine candidates are on temporary hold while the company investigates whether a patient suffered a serious side effect or if the illness had nothing to do with the shot.

In a statement issued, the company said its ''standard review process triggered a pause to vaccination to allow review of safety data.''

The company, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a Covid-19 vaccine. Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany's BioNTech.

AstraZeneca didn't reveal any information about the possible side effect except to call it a potentially unexplained illness.'' The health news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom.

An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the U.S. and other countries. Late last month, AstraZeneca began recruiting 30,000 people in the U.S. for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.

Late last month, AstraZeneca began recruiting 30,000 people in the US for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.

The trial, named NCT04507256, will evaluate the safety, tolerability and pharmacokinetics, or drug movement through the human body, of AZD7442. It will include up to 48 healthy participants in the UK, aged 18 to 55 years.

Should AZD7442 prove to be tolerated and have a favourable safety profile in the trial, the firm says it will then progress it into larger late-stage Phase II and Phase III trials to evaluate its efficacy as a potential preventative and treatment approach against COVID-19.

The announcement follows worries that President Donald Trump will pressure the US Food and Drug Administration to approve a vaccine before it's proven to be safe and effective.