Oxford Vaccine Trial to Begin in 3 to 4 Sites - Experts Share Fresh Details

As most of the COVID-19 vaccines are going on trial, the phase 2 human clinical trials of the Oxford University-AstraZeneca vaccine will begin its trial in the coming week. This vaccine has been manufactured by Serum Institute of India (SII). 

Top officials at the Indian Council of Medical Research (ICMR) said, three-four trial sites have demonstrated the requisite preparedness, and doses of the candidate vaccine could be administered as early as Monday or Tuesday. 

Giving further updates on it, the official said the government has allowed fast-tracking of regulatory clearances for the vaccine against the novel coronavirus. 

Meanwhile, the final approval was related to certification from the Directorate General of Health Services’ Central Research Institute in Kasauli, Himachal Pradesh that will be useful for the investigation product in Phase 2/3 clinical trials. Also, the trials can begin simultaneously at all sites that are prepared, ICMR officials confirmed. 

Four of the 14 trial sites are in Pune, and two are in Mumbai. The ICMR-Regional Medical Research Centre, Gorakhpur, and two other sites will not be part of the clinical trials, the official added. 

According to Indian Express report, the Oxford-AstraZeneca candidate – ChAdOx1 nCoV-19 (AZD1222) – has shown encouraging results in early human trials. However, the Pune-based Serum Institute is conducting Phase 2/3 clinical trials of the candidate, which has been named as Covishield in India.

Dr Sanjay Lalwani, Medical Director of Pune’s Bharati Vidyapeeth Deemed University Medical College and Hospital said: “We are ready to start the trial, and are waiting for official communication from the authorities. If the vaccine doses are sent on Monday, we can begin Phase 2 clinical trials on Tuesday. Many people want to enrol. We have committed to enrol 350 trial participants."