Bharat Biotech says it has recruited 8,000 participants in phase-3, justifies seeking emergency use approval

1 | Pfizer, BioNTech COVID-19 vaccine 95% effective in final results, shows study: Pfizer Inc on November 18 said its COVID-19 vaccine with partner BioNTech SE was 95 percent effective in the final analysis based on clinical trials data. The companies are all set to seek emergency authorisation for use of the shots from regulators.

Bharat Biotech on Saturday said it has so far recruited 8,000 participants out of the proposed 22,000 people in the phase-3 efficacy trial. The pharma giant had initiated phase-3 trials on November 17.

“This is the first efficacy trial in developing world, India has not done an efficacy trial,” said Krishna Ella, Chairman and Managing Director of Bharat Biotech, speaking at a FICCI event.

“We have done 2,000 people in phase-1 and phase-2, 8,000 completed in phase-3, and we have extremely good efficacy data in monkeys and hamsters. We have extremely good pre-clinical data, and extremely good data on safety profile,” Ella said.

Ella said that Covaxin can be given to candidates ranging from six months old baby to a 65 year old person.

Ella said his company did not jump into it without having any evidence.

“We can ask for emergency approval based on phase-1 & 2 and also pre-clinical efficacy data,” Ella said.

“We do have microneutralization assays, parameters of correlation. We have multiple evidences to prove that it has got similarities. China and Russia has given emergency license, there is nothing wrong in it.

Microneutralization assay is used for detecting virus- specific neutralizing antibodies.

Ella said Covaxin is based on 35 year old proven technology, and not something new.

“We have filed for the emergency license, but it is left to the government to review all those things, we are giving whatever data they want. We have done everything to according international standards, not India standards,” he said.

On serious adverse event related to Covaxin, he said 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 (DSMB), and the ethics committee," Ella said.