COVID-19 vaccine update: SII begins phase 2, 3 clinical trials on 1,600 volunteers, says report

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Updated: Aug 19, 2020 7:09 PM

DCGI had given SII the approval to conduct phase 2 and phase 3 trials of the Covid-19 vaccine candidate of Oxford-AstraZeneca. While the official name of the vaccine candidate is AZD1222, Serum Institute has named it Covishield.

As per the Clinical Trial Registry India, the phase 2 and 3 of SII’s vaccine candidate Covishield will be random, observer-blind and a controlled study to evaluate its immunogenicity and safety. (Representational image)

After receiving a go-ahead from the Drugs Controller General of India (DCGI) earlier this month, Serum Institute of India (SII) has begun the phase 2 and phase 3 of clinical trials to ascertain the safety and immune response of its Coronavirus vaccine candidate.

ANI reported on Wednesday that as per the Clinical Trial Registry India, the phase 2 and 3 trials of SII’s vaccine candidate Covishield will be random, observer-blind and a controlled study to evaluate its immunogenicity and safety.

The report added that these trials will be conducted on 1,600 participants who will be spread across 17 sites in the country. The trials will be held at Andhra Medical College at Vishakhapatnam, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) Patna, AIIMS Delhi, Andhra Medical College in Visakhapatnam, AIIMS Jodhpur, BJ Medical College, Pune, ICMR Regional Medical Research Centre in Gorakhpur, Post Graduate Institute of Medical Education and Research in Chandigarh, JSS Academy of Higher Education & Research in Mysuru, among other centres.

Earlier, SII had scheduled to meet the principal investigators of these trial centres to ensure that all trial sites conduct the trial in accordance with protocols and regulations, IE reported.

DCGI had given SII the approval to conduct phase 2 and phase 3 trials of the Covid-19 vaccine candidate of Oxford-AstraZeneca. While the official name of the vaccine candidate is AZD1222, Serum Institute has named it Covishield.

As per the Indian norms, in addition to the trials undertaken by the parent developers, before its use in the country, all foreign vaccine candidates have to undergo clinical trials on a large scale on the Indian population.

IE had also reported SII as saying that out of its total production, it would be providing at least 100 million vaccine doses at a price as much as Rs 240 for each dose. SII had said that this would be enabled by the $150 million funding it received from the Bill and Melinda Gates Foundation to accelerate the production of the vaccine.

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