Bharat Biotech Chairman Krishna Ella on January 4 said that it is unfair to accuse the company of inexperience as it is a global entity with experience in manufacturing vaccines in emergency situations when efficacy data is not available. The company's COVID-19 vaccine Covaxin's efficacy data will be released by March 2021, he stated.
Responding to criticism over conditional approval granted to Covaxin, Ella said Bharat Biotech doesn’t deserve this backlash. "We have experience in bringing vaccines in emergency situations when efficacy data is not available," Ella said, adding, "It is not correct to say that we are not transparent with data. We have manufactured more than 16 vaccines and we don't deserve this backlash."
DCGI grants Bharat Biotech permission to conduct vaccine trials on children above 12: Report
He said the Drugs Controller General of India (DCGI)'s 2019 guidelines says if a vaccine platform is established and approved, it can be cleared for trial. He mentioned multiple examples where emergency authorisation was given based only on the immunogenicity data.
On the issue of trials, he said: "Covaxin Phase-3 trials are on-going, it's a 2-dose schedule and 24,000 people vaccinated so far... We have 20 million doses, will have 500 million dose capacity by end of 2021."
The Bharat Biotech chief said in his defence that all the company's vaccine samples have been validated by NIV Pune, and the process is fully transparent. "Have published five articles on the vaccine. We are in no way inferior to Pfizer when it comes to publications, as it has zero publications. Safety data for Covaxin shows less than 10 percent side effects in trials."
Ella added that volunteers came forward without any financial incentives.
The DCGI on January 3 approved Bharat Biotech's COVID-19 vaccine 'Covaxin' for conducting trials on children above the age of 12 years. Ella even mentioned that no interim analysis of efficacy in Phase-3 has been done so far, while DCGI used animal challenge study data for approval of the vaccine.
Currently, the Hyderabad-based firm is conducting Phase-3 trials and yet to complete late-stage human clinical trials in India.