As per the minutes of the SEC meeting, the SII was asked to submit, specifically, safety data on Phase 2/3 clinical trials in India of its vaccine candidate named Covishield, developed by Oxford-AstraZeneca; immunogenicity data from the clinical trial in the United Kingdom and India; as well as the outcome of the United Kingdom regulatory authority's assessment regarding its emergency use authorisation application. "After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration", the minutes of the meeting showed.
It may be recalled that the Covaxin is now under phase III trials and the Bharat Biotech Chairman Dr Krishna Ella d the delegates about the progress of the Covaxin. During his presentations, Mr Krishna Yella said the results of ongoing third phase clinical trials are satisfactory.
India has bought 1.6 billion doses of Covid-19 vaccines, which is more than any other country, according to a global analysis.
Queries sent to the SII and Pfizer remained unanswered, while Bharat Biotech declined to comment on the meeting.
Bharat Biotech joint managing director Suchitra Ella said, "The development and clinical evaluation of COVAXIN marks a significant milestone for novel vaccinology in India". Last month the vaccine successfully completed Phase 1 and 2 trials and now phase 3 trial, human clinical trial, has begun at AIIMS in New Delhi.
Another said: "The CDSCO just wants more data on efficacy and safety before making a decision".