Recruited 8,000 volunteers already for phase 3 trials: Bharat Biotech head

The company says they are '200% transparent' about serious adverse events with regulator

Hyderabad based vaccine major Bharat Biotech, which has applied for an accelerated approval from the drug regulator based on phase 1 and 2 clinical trial data last week, said that they have already recruited 8,000 volunteers for a 22,000 subjects phase 3 clinical trial.

Speaking at a FICCI event, Krishna Ella, chairman and managing director of Bharat Biotech International (BBIL) said that they have already recruited 8000 people for its phase 3 clinical trials. "Out of 22,000 volunteers, we have already recruited around 8000 volunteers. In the last fifteen days we have recruited actively," he said.

BBIL began the phase 3 trials on November 17.

The company had applied for marketing approval based on phase 1 and 2 data, he added. Ella felt that since data from monkeys have shown the efficacy of the vaccine, and the phase 1 and 2 human trial data showed that it was safe, one could apply for marketing approval. Commenting on the vaccine development process, Ella said, "Everything has been done according to international standards."

He further added that the vaccine is safe and that the firm was 200 percent transparent in case of any serious adverse events. "We are not inhuman people, we are sensitive about our volunteers. But we cannot disclose their names due to confidentiality. Transparency means whether we report events to the regulator, the Data and Safety Monitoring Board, and the ethics committee," Ella said emphatically.

"The vaccine is safe, built on time tested and proven technology. It can be given to a six month old or to a 60-year old," Ella said. Vaccine approvals in India would, however, initially be for adults of those above 16-years.

Ella felt that both Russia and China have gone ahead with emergency approvals based on early stage trial data.

This is the first efficacy trial in the developing world, including India, Ella claimed. The phase 3 studies by Serum Institute of India (SII) for Covishield and Dr Reddy's Laboratories for Sputnik V, are to check the safety and immunogenicity of their respective vaccine candidates.

Efficacy trials are large late stage trials that test the efficaciousness of the vaccine candidate - basically test how many people in the placebo arm get the disease vis a vis the people in the vaccinated arm. Safety and immunogenicity trials test for any toxicity or adverse event the vaccine may produce and whether it induces the desired immune response in volunteers against the pathogen.