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Covid-19: Serum Institute puts Oxford vaccine's India trials on hold

Serum Institute of India (SII) on Thursday said it is pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in the country.

Coronavirus Vaccine | AstraZeneca | Serum Institute

Press Trust of India  |  New Delhi 

Coronavirus, vaccine, covid, drugs, Sepsivac, clinical trials

of India (SII) on Thursday said it is pausing clinical trials of Oxford COVID-19 vaccine candidate in the country.

Earlier this week, said it had paused the trials because of 'an unexplained illness' in a participant in the study.

However, SII on Wednesday said it was continuing with the trials and had not faced any issues.

SII's latest announcement also comes against the backdrop of the central drug regulator DCGI issuing a show-cause notice to SII for not informing it about pausing the clinical trials of the Oxford vaccine candidate in other countries.

"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement.

The Pune-based vaccine maker also said it is following instructions of the Drugs Controller General of India (DCGI), it added.

In the show-cause notice, DCGI V G Somani had asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Thu, September 10 2020. 17:38 IST