Covid-19: Human trials of Oxford vaccine set to begin in 2 weeks, Serum Institute, ICMR members to meet today

By: |
August 14, 2020 11:28 AM

Apart from the representatives from the pharma company, some members from regulator Indian Council of Medical Research (ICMR) will also partake in the meeting.

Representatives from the ICMR told the IE that the meet was a routine procedure which is conducted to ensure that all trial sites conduct the trials in accordance with the protocols and other regulations

Serum Institute of India which is going to undertake the human trials of Oxford-AstraZeneca Covid-19 vaccine in India, will meet the principal investigators at 17 different trial sites in the country where the trials will be conducted. The virtual meet has been convened by the pharma company to formulate a common strategy and establish a standard procedure for conducting the phase 2 and phase 3 clinical trials of the vaccine. Apart from the representatives from the pharma company, some members from regulator Indian Council of Medical Research (ICMR) will also partake in the meeting, according to an Indian Express report.

Representatives from the ICMR told the IE that the meet was a routine procedure which is conducted to ensure that all trial sites conduct the trials in accordance with the protocols and other regulations. Other steps which are to follow before the commencement of the human trials of the vaccine are seeking permission from the Ethics committee, visiting the sites and inviting volunteers for the trials. All these steps are expected to be wrapped in two week’s time and the human trial of the Oxford-AstraZeneca vaccine might start anytime after August 25.

Earlier, the Serum Institute had got the approval from the Drug Controller General of India (DCGI) to conduct the 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 given the name of Covishield to the vaccine in India. In accordance with the procedure established in the country, any foreign vaccine candidate before its use in the country will undergo large scale clinical trials on the Indian population in addition to the trials undertaken by the parent developers.

Among the 17 clinical trial sites approved for the human trials of the vaccine in India, four are in the city of Pune. Dr Sanjay Lalwani, principal investigator for the clinical trial at Bharati Hospital, Pune told the Indian Express that the hospital has already got the approval from the Ethics Committee on Wednesday. Dr Ashish Bawdekar, principal investigator at KEM Hospital and Research Centre also told the Indian Express that the hospital has got the Ethics’ Committee approval.

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