The Gorakhpur-based ICMR-Regional Medical Research Centre and two other sites would not be participating in the trials.
Oxford COVID-19 vaccine: Second phase of Oxford coronavirus vaccine trials is about to begin. The coronavirus vaccine candidate being developed by Oxford University and pharmaceutical firm AstraZeneca is set to enter the second phase of human clinical trials in the coming week, according to a report in IE. The vaccine is being manufactured by Pune-based Serum Institute of India (SII). The report quoted top officials of Indian Council of Medical Research (ICMR) as saying that three-four sites for trial have been found to have the required preparedness. They further said that the administration of doses could begin by Monday or Tuesday.
The report stated that fast-tracking of the regulatory approvals has been allowed by the government for coronavirus vaccines. The final approval that was needed was regarding a certification from Himachal Pradesh’s Kasauli-based Directorate of General Health Services’ Central Research Institute, the report stated, adding that this was for using the investigational product in phase 2/3 trials.
Officials said that all the prepared sites could simultaneously begin conducting the trials. Out of the 14 trial sites, four are in Pune, while two are in Mumbai. Apart from that, the Gorakhpur-based ICMR-Regional Medical Research Centre and two other sites would not be participating in the trials, the IE report added.
The vaccine candidate developed by Oxford and AstraZeneca is presently known as ChAdOx1 nCoV-19 (AZD1222), and during the early human trials, it displayed encouraging results. SII, which is the largest vaccine manufacturer in the world, is conducting the trials for the candidate in India, the report stated. In the country, the candidate is being called Covishield.
The IE report quoted Pune-based Bharati Vidyapeeth Deemed University Medical College and Hospital’s Medical Director, Dr Sanjay Lalwani, as saying that they are prepared to begin the trials, and are only waiting for authorities to send the official communication. He added that if they get the vaccine doses on Monday, they would begin the second phase of human trials on Tuesday itself. Adding that several people had expressed their desire to participate in these trials, he said that they have committed to enrol 350 volunteers for this.
Meanwhile, another testing site at Pune, the Jehangir Clinical Development Centre is also ready to start the trials and is just waiting to receive the vaccine doses, the report cited its CEO Pathik Divate as saying. The centre would enrol 250 to 300 participants and the criteria for selection of candidates included being healthy, never having been infected with the virus and being above 18 years.
SII has partnered with AstraZeneca to manufacture the vaccine, if approved, in India, and Covishield would be released for commercial use once the vaccine candidate completed the trials successfully and received regulatory approval.
The human trials would be randomised and would be conducted using a double blind method, which means that neither the participants nor the researchers would know who got the vaccine and who got the placebo, the report stated.