Pune-based Serum Institute of India (SII) on September 9 said the trials of the AstraZeneca-Oxford COVID-19 vaccine have not been paused in India, adding that the vaccine candidate's trials in the United Kingdom had been put on hold.
"We (Serum Institute of India) can't comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all," SII has said.
This comes after the pharma company said on September 8 that the company's "our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," as reported by American news website Stat.
The late-stage trials of the highly-anticipated COVID-19 vaccine candidate have been put on a temporary hold due to an adverse reaction in a participant in the UK. AstraZeneca is now investigating if the report of a patient with a serious side effect is linked to the shot.
Temporary holds of large medical studies aren’t unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it’s possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people.
From among the vaccines that are currently under development, the AstraZeneca-Oxford vaccine is being seen as one of the most promising candidates against the novel coronavirus infection.