INDIA's Serum Institute has started clinical trials for for ‘Covishield’ vaccine developed by the University of Oxford with the first patients screened by Bharati Vidyapeeth deemed university medical college and hospital in Pune.
According to reports, the hospital aims to have about 300-350 participants as part of the trial.
They will be tested for covid antibody and if they come negative the ‘Covishield’ vaccine will be administered on them, a top official said.
Indian Council of Medical Research director general Balram Bhargava has confirmed that the trials for the ‘Covishield’ vaccine have begun. The ICMR is the secondary sponsor to the phase 2 and 3 trial of around 1,600 patients.
So far, seven hospitals, including BVDU, of the 17 sites have received ethics committee approval, according to the government’s clinical trial registry.
Hospitals such as Jehangir Clinical Development Center and KEM Hospital in Pune, King George Hospital at Visakhapatnam, Rajendra Memorial Research Institute of Medical Sciences at Patna, are expected to start screening of patients later this week.
Serum Institute, which is the world’s largest vaccine manufacturer by volume, had in June signed an agreement with British-Swedish multinational pharmaceutical company AstraZeneca to supply an additional one billion doses, principally for low- and middle-income countries.
The company had secured the Indian drug regulator’s approval to conduct a phase II and III trial as per regulations.
It is the third firm to conduct human trials of a covid-19 vaccine in India after Bharat Biotech (for Covaxin) and Zydus Cadila (for ZyCoV-D) started phase I and II trails last month.
The Bill & Melinda Gates foundation will provide at-risk funding of $150 million to Serum Institute of India’s manufacturing of two promising vaccines by University of Oxford and Novavax. Under the scheme, the maximum price for the vaccine should be $3 per dose.
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