Bharat Biotech has submitted phase 3 trial data for coronavirus vaccine Covaxin to the Drug Controller General of India over the weekend, NITI Aayog (Health) member VK Paul told The Economic Times on Monday.
“Covaxin follow-up studies should be available, too, in peer-reviewed journals soon,” Paul said.
The indigenously developed vaccine was granted emergency use authorisation in January though data of phase 3 trials were not available at that time. The company had then said it would submit efficacy results by March. On June 9, it said that the data will be made public in July.
Phase 1 of a clinical trial is usually small and is used to determine its safety profile. Phase 2, on the other hand, employs a bigger sample size, and looks at the immune responses triggered by the vaccine. However, a vaccine is deemed safe to be commercially available only after Phase 3 – a much larger efficacy trial involving thousands of participants.
The drug regulator’s Subject Expert Committee will meet on Tuesday to review the results, a senior official told The Economic Times.
The Hyderabad-based company is also expected to hold a “pre-submission” meeting on Wednesday with the World Health Organization for emergency use listing of its vaccine. This meeting will provide an opportunity to Bharat Biotech to receive advice and guidance from authorities before final submission of documents.
The emergency use listing involves rigorous assessment of clinical trial data. An approval from the global health body will allow the company to export its vaccines. Additionally, it will facilitate easier international travel of Indian citizens who have been administered Covaxin.