The clinical trials of Oxford vaccine will continue in India as usual as it has faced no issue at all, the Serum Institute of India (SII) said on Wednesday, 9 September over the recent report of phase-three study of the COVID-19 vaccine being put on hold in the United Kingdom, as one of the participants reported a suspected severe adverse reaction.
In a statement to IANS, the SII cleared the air on the impending trials of the vaccine in India.
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 SII issued statements after reports started flourishing about a temporary halt in phase-three study of the COVID-19 vaccine candidate jointly developed by Oxford University and AstraZeneca in the UK after one of the volunteers developed an “unexplained” illness there.
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 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”.
The nature of the adverse reaction and when it happened was not immediately known, though the participant is expected to recover, Stat News reported.
The spokesperson of the company described 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 the company is “working to expedite the review of the single event to minimise any potential impact on the trial timeline”.
SII was the partner of the University of Oxford's Jenner Institute to conduct the vaccine trials. At present, SII is progressing the second and third-phase studies of the vaccine candidate at 17 trial sites.
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