Oxford vaccine trial put on hold

UK participant falls ill; Independent panel to review safety data

Trials across 5 continents

*The Oxford University’s Jenner Institute team started working on the vaccine in January this year.

*The trials had moved into Phase III after successful Phase I and II testing

*Trial volunteers for the vaccine are located in countries across five continents, including India, UK, Brazil, S Africa and the US.

Assessment to be expedited

*British drugmaker AstraZeneca, which is developing the vaccine with the University of Oxford, says it has paused trials to allow an independent committee to review safety data

*The team is working to expedite the review of the “single event” (unexplained illness) to minimise impact on the trial timeline.

London, September 9

The human trials of one of the most promising Covid-19 vaccine candidates, being developed by the University of Oxford, has been put on hold after a UK participant had an adverse reaction to it.

AstraZeneca, the biopharmaceutical giant in tie-up with the university to produce the vaccine, described the pause as a “routine” one following what was “an unexplained illness”.

The trials had moved into Phase III after successful Phase I and II testing had raised worldwide hopes that it would be ready by early next year as results showed that it produced a positive immune response.

The vaccine moved to Phase III testing in recent weeks, involving around 30,000 participants in the US, UK, Brazil and South Africa.

“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused the vaccination to allow a review of safety data by an independent committee,” said a spokesperson for AstraZeneca on Tuesday evening.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, ensuring we maintain the integrity of the trials. In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully,” the spokesperson said.

Stressing that the adverse reaction involved only a single patient, the spokesperson added that the team was working to expedite the review of the “single event” to minimise any potential impact on the trial timeline.

“We are committed to the safety of our participants and the highest standards of conduct in our trials,” the spokesperson said.

Phase III trials in vaccines often involve thousands of participants and can last several years.

For ChAdOx1 nCoV-19, the so-called Oxford vaccine, clinical trial volunteers are located in countries across five continents, including India, UK, Brazil, South Africa and the US.

Given the urgency to control the spread of the novel coronavirus which has claimed thousands of lives around the world, it was hoped the trials would be speedier and that a vaccine may be ready as early as January 2021.

The Oxford University’s Jenner Institute team started working to develop a vaccine against the SARS-CoV-2, or the virus which causes Covid-19, in January this year and says it has been working with “unprecedented urgency” in a race against the coronavirus.

Phase I and II results had proved positive as they showed that the vaccine induced strong antibody and T-cell immune responses for up to 56 days after they were given. T-cells are crucial for maintaining protection against the virus for years.

According to Oxford University scientists, of the hundreds of potential COVID-19 vaccines in development, six are in the final stages of testing, known as Phase III clinical trials. PTI