The Phase 2 and Phase 3 clinical trials of the Oxford-AstraZeneca vaccine for Covid-19 is likely to start over this weekend. The Brihanmumbai Municipal Corporation is expecting the Indian Council of Medical Research (ICMR) to give a green signal to the queries raised by the ethics committee of King Edward Memorial (KEM), Parel and BYL Nair hospitals, which have been selected to run the trial in Mumbai. Last week, the ethics committee had sent two queries to the ICMR about the trial.
“We had sent two queries to ICMR asking about the budget and insurance of the volunteers who will participate in the trial. The amount of the trial has to be similar all across the country. So, the council needs to inform us about the insurance amount,” said a civic official.
BMC Additional Municipal Commissioner Suresh Kakani said, “We are expecting ICMR will give a nod to go ahead, however, if the queries get resolved, we will start the trial by this weekend,” said the officer.
Dr Hemant Deshmukh, dean, KEM hospital said that the Indian Council for Medical Research (ICMR) had written to the hospital regarding the vaccine trial on August 7. This vaccine will be manufactured by Pune-based Serum Institute of India. “So far we have got 186 persons who are willing to be participants for the trial. We are yet to start our formalities. We will get permission after we answer queries of the ethics committee,” he said. Each participant will be given a 0.5 ml dose intramuscularly. He added that the only side effect can be mild fever for one or two days.
Meanwhile, Pune on August 26 started the Phase 2 clinical trials of Oxford vaccines. Five volunteers have been administered with the vaccines.
Only healthy individuals will be selected for the trial. Those who have been infected with Covid-19 earlier will not be eligible. The vaccine is being tried at 10 centres in India with 1,600 persons. Simultaneously, the trials will be held in the US and Brazil. The trial will test immunogenicity and safety of the vaccine.
The COVID-19 vaccine has been developed by the University of Oxford and AstraZeneca. British-Swedish firm AstraZeneca partnered with Serum Institute of India to manufacture the vaccine for India and low and-middle income countries.