The Office of the Drug Controller General of India (DCGI) has authorized the proposal of the Serum Institute of India for Phase II and III clinical trials of the University of Oxford’s covid-19 vaccine candidate Covishield, the Ministry of Health of the Union said on Monday.
The Pune-based Serum Institute is the third firm to secure clearance for clinical trials in India after Bharat Biotech (for Covaxin) and Zydus Cadila (for ZyCoV-D), which obtained permission for Phase I and Phase II trials last month.
DCGI’s acceptance came after last week’s expert committee suggested that the firm be permitted to perform clinical trials after reviewing the company’s updated plan for a 1,600-patient human trial.
In June, the firm, which is the world’s largest producer of vaccines by the number of doses commercialized worldwide, signed an agreement with the UK-Swedish multinational pharmaceutical company AstraZeneca, the co-developer of the vaccine, to supply an additional 1 billion doses, primarily to low-and middle-income countries.
More than 150 vaccines are awaiting clinical testing, of which more than two dozen are conducting human trials. However, the Oxford University vaccine candidate is regarded as the front runner.
Interim results from a clinical trial released last week in The Lancet Journal found that the vaccine candidate was healthy and offered dual immunity towards highly infectious respiratory diseases. The Serum Institute plans to market the vaccine at less than 1,000 a dose. CEO Poonawalla has stated that the organization will target around half of the vaccines it manufactures for India.
