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Panel recommends permission to Serum Institute for phase 2, 3 human clinical trials of Oxford vaccine candidate

IndiaTimes Friday, 31 July 2020 ()
A subject expert committee on Covid-19 on Friday recommended to the country's drug regulator that permission be granted to Serum Institute of India (SII) for conducting the second and third phases of human clinical trials of the Oxford vaccine candidate.
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News video: COVID update: India to start late stage trials of Oxford vaccine, Shivraj tests positive again

COVID update: India to start late stage trials of Oxford vaccine, Shivraj tests positive again 01:38

The Drugs Controller General of India (DCGI) has given approval to Serum Institute of India (SII), Pune, to conduct Phase II and III clinical trials of Oxford University. According to the World Health Organization (WHO), a number of vaccines are now in phase-3 clinical trials. Meanwhile, Chief...

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Director General of Indian Council of Medical Research, Dr Balram Bhargava on August 04 stated that Oxford vaccine, being manufactured by Serum Institute of India, got approval for phase 2 and 3 clinical trials which are starting within a week at 17 sites. Earlier, the Drugs Controller General of India (DCGI) has given approval to Serum Institute of India (SII), Pune, to conduct Phase II and III clinical trials of Oxford vaccine.

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Covid | 'Oxford vaccine's late stage trials to start in a week in India': ICMR [Video]

Covid | 'Oxford vaccine's late stage trials to start in a week in India': ICMR

At present country has three Indian COVID-19 vaccines which are in different phases of clinical testing, said Indian Council of Medical Research (ICMR) Director General Dr Balram Bhargava on Tuesday. Addressing a press conference in the national capital, he said, "At the present moment, we have three Indian vaccines which are in different phases of clinical testing. The 2 vaccines- Bharat Biotech vaccine and DNA vaccine of Zydus Cadila have completed phase 1 and will begin phase 2 while third is Oxford vaccine." "Oxford vaccine, being manufactured by Serum Institute of India (SII) got approval for phase 2 and 3 clinical trials, which are starting within a week at 17 sites," he added. Dr Bhargava, however, said that social distancing and proper hygiene are the best "vaccine" available now and even after. "Physical Distancing, wearing a mask, proper hand hygiene are the best vaccine available at the moment and even after. We will have to continue with these measures," he said. India has so far recorded over 18 lakh cases and more than 38,900 deaths.

Credit: HT Digital Content    Duration: 06:42Published

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DCGI asks Serum Institute to revise protocol for phase 2, 3 trials of Oxford COVID-19 vaccine

A CDSCO expert panel has sought clarifications from Serum Institute of India (SII) over its application to the DCGI seeking permission for conducting phase 2 and...
IndiaTimes Also reported by •Hindu

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