A late-stage Phase III trial on the Covid-19 vaccine candidate from the AstraZeneca-Oxford University combine has been “put on hold” due to a possible serious adverse reaction in a trial participant in the United Kingdom, according to reports.
A report in STAT NEWS quoted a statement from AZ as saying, a “standard review process triggered a pause to vaccination to allow review of safety data.”
The AZ-Oxford University candidate is among a handful of Covid-19 vaccines that are in large-scale advanced trials in different parts of the world, the final leg before getting a regulatory approval to be marketed. India’s Serum Institute has an alliance to make and market this vaccine in low- and middle-income countries, once it was ready for mass use. In fact, trials are underway on this vaccine candidate in India as well.
The report said, “AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.”
It further quoted the AZ spokesperson as describing the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimise any potential impact on the trial timeline,” the report added.
Not only have countries like the UK and the US put their money on these possible candidates in advance, to have a vaccine ready for use, as soon as one was ready, but also companies like AZ and Serum Institute have agreed to make the vaccines “at risk”, even as final studies were being undertaken to speed up the availability.
More details are awaited from the company on the impact this could have on trials in various countries across the world, including India.