The Serum Institute of India (SII) stated on Wednesday that the clinical trials for Oxford vaccine will continue in India as usual as it has faced no issue at all. The statement comes amidst reports of phase-three study of the Covid-19 vaccine being put on hold in the United Kingdom as one of the participants reported severe adverse reaction.
"Commenting on the recent reports over AstraZeneca halting the trials in the UK, Serum Institute of India (SII) said, "We can`t comment much on the UK trials but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all," the statement read.
The development comes a day after AstraZeneca and eight other drugmakers vowed to uphold the highest ethical and scientific standards in developing their vaccines.
Earlier, a spokesperson for AstraZeneca said the company`s "standard review process triggered a pause to vaccination to allow review of safety data".
"Our standard review process was triggered and we voluntarily paused vaccination to allow the review of safety data by an independent committee," company spokeswoman Michele Meixell said in an emailed statement.
AstraZeneca Plc on Tuesday said it has paused a late-stage trial of one of the leading COVID-19 vaccine candidates after an unexplained illness in a study participant.
The SII ensured that the incident in the UK would have no impact on the Indian vaccine trial carried out at 17 trial sites across India.
The study is testing a COVID-19 vaccine being developed by AstraZeneca and the University of Oxford researchers at various sites, including the United Kingdom, where the illness was reported.
The nature of the case and when it happened were not detailed, although the participant is expected to recover, according to Stat News, which first reported the trial was halted due to a "suspected serious adverse reaction." The U.S. Food and Drug Administration defines that as an adverse event in which evidence suggests a possible relationship to the drug being tested.
The suspension of the trial has impacted other AstraZeneca vaccine trials - as well as clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.
SII was the partner of the University of Oxford`s Jenner Institute to conduct the vaccine trials. At present, SII was progressing the second and third-phase studies of the vaccine candidate at 17 trial sites.
(With IANS inputs)