Serum Institute of India pauses clinical trials after DCGI s
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Updated as on 10 September, 4 pm:

A day after the Serum Institute of India received a notice from the Drugs Controller General of India for not halting trials of the Oxford COVID-19 vaccine candidate, the Pune-based company announced that Phase III trials have been paused till AstraZeneca resumes trials.

"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front," the Serum Institute said in a statement on 9 september.

Trials for the vaccine were stopped in four nations as a precautionary measure after one of the recipients in the UK showed some adverse symptoms, which are yet to be linked to the vaccine.

The Serum Institute of India had been issued a show-cause notice by the country's drug controller DGCI. In its notice, the Drugs Regulator General of India questioned why the Serum Institute is progressing with the trials and why it has not sent a detailed report about the patient in the UK.

On 9 September evening, the Serum Institute said, "We are going by DCGI's direction and so far we're not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols."

In a statement earlier in the day, the Pune-based vaccine manufacturer said the Indian trials are continuing and they have faced no issues at all. The company also said they "can't comment much on the UK trials, but they have been paused for further review".

Also read: https://www.plexusmd.com/md/post/astrazeneca-pauses-covid-19-vaccine-trial/57900

Source:
1. https://www.ndtv.com/india-news/coronavirus-serum-institute-of-india-gets-notice-after-oxford-covid-19-vaccine-trial-paused-2293003

2. https://www.firstpost.com/health/coronavirus-vaccine-tracker-serum-institute-of-india-pauses-clinical-trials-after-dcgi-show-cause-notice-8803781.html

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