The subject expert committee, which discussed the matter in a meeting held on October 5, has asked the Hyderabad-based company to resubmit the protocol.
“After detailed deliberation the committee opined that the design of the phase III study is in principle satisfactory except for clarification on definition of asymptomatic, etc,” said the minutes of the meeting. “However, the study should be initiated with appropriate dose identified from the phase II safety & immunogenicity data. Accordingly, the firm should submit safety & immunogenicity data from phase II trial for consideration.”
The company had approached the drug controller’s office and presented its phase III clinical trial protocol along with interim data of phase I and II clinical trials. “The committee noted the interim data of phase I & II clinical trial,” it said.
The company has already approached the states for initiating phase III trials this month. As reported by ET earlier, the company has written to various states including Delhi, Uttar Pradesh, Bihar, Maharashtra, Punjab and Assam, seeking their permission and facilitation to initiate the trial.
“We are planning to initiate a large phase 3 multicentre study to evaluate the efficacy and safety of the vaccine,” it said in a letter to the principal secretaries of these states.