Published 19:56 IST, September 9th 2020
COVID-19 vaccine: 'Oxford trials not paused in India', clarifies Serum Institute
The clinical trials of the Oxford COVID-19 vaccine are continuing in India and have not faced any issue so far, pharmaceutical giant Serum Institue of India
The clinical trials of the Oxford COVID-19 vaccine are continuing in India and have not faced any issue so far, pharmaceutical giant Serum Institue of India (SII) clarified on Wednesday after AstraZeneca paused testing in Britain after a patient volunteering for the vaccine trial fell ill. The UK-based company said it is still trying to investigate whether the sudden illness of a candidate is a serious side-effect of the vaccine.
"We can not 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," SII said in a statement.
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AstraZeneca pauses its COVID-19 vaccine trial
As per the statement issued by AstraZeneca on September 8, Tuesday, the company announced that it's standard review process has triggered a pause to vaccination to allow the review of safety data. However, the company has not shared any more information about the possible side-effect rather than just calling it 'a potentially unexplained illness'. Right after the news of pause in the COVID-19 vaccine trial of AstraZeneca came out, its U.S trade shares fell by 6 per cent immediately. The spokesperson of AstraZeneca has confirmed the pause in COVID-19 vaccination cover studies in the U.S and other countries.
The SII had initiated the phase two and three clinical trials to evaluate the safety and immune response of the Oxford University coronavirus vaccine candidate on healthy Indian adults after the pharma company got approval from the Drugs Controller General of India (DCGI) last month. In India, the vaccine would be manufactured by the company.
According to the Clinical Trial Registry India, the scientific title of the study says that phase 2/3 clinical trial will be an observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indian adults. A total of 1,600 eligible participants of more than or equal to 18 years of age will be enrolled in the study, which will be conducted on 17 sites in India.
(With ANI inputs)
Updated 19:56 IST, September 9th 2020