Covaxin: Amid row over deadline, 1,000 volunteers for trials

Bharat Biotech International Ltd. had received regulatory approval to start human trials for its experimental shot this week India’s urgent need for vaccine to halt the dreaded coronavirus spread looks understandable as the nation has more than seven lakh infected people — world’s third-largest in number of cases.

In a letter, ICMR had urged the trial sites to enroll volunteers by July 7. According to reports from various sources, Bharat Biotech plans to enroll 375 people in the first phase of clinical trials and 750 people in the second phase.

An ICMR spokesperson said that whether the vaccine will be approved for general use depends on the outcome of the trials, though the company source preferred not to comment on August 15 deadline.

The IASc, meanwhile, said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.

While administrative approvals can be expedited, the “scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour”, the IASc said in a statement.

The trial will start “most probably” soon, C. Prabhakar Reddy, a professor in Hyderabad’s Nizam’s Institute of Medical Sciences — one of the trial sites that received ICMR’s letter was quoted as saying. “It will be neck and neck race to meet deadline (August 15), he was further quoted to day and he also believed that there will not be any shortage of volunteers.

The IASc said trials for a vaccine involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial), and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use.