NEW DELHI: Under fire for receiving approval for its Covid-19 vaccine Covaxin in the country without presenting any efficacy data, Bharat Biotech on Monday confirmed that it has not presented any results from the late-stage trials and added that evidence of its efficacy will be available by February-March.
Company chairman Krishna Ella, in a virtual press briefing, said that his company “gave excellent safety data tested on around 25,000 participants”, adding that they are “confident of having efficacy above the set benchmark of 50 %”.
Covaxin, along with Covishield by SII, had been granted restricted use permission in the country last week and is expected to be launched in days ahead. According to Ella, the company plans to produce the doses in four of its facilities based in Hyderabad and Bengaluru.
“We have 20 million doses right now. We can manufacture 700 million doses in 2021,” Ella said adding that the company has manufactured a stock pile of one crore doses already even before the vaccine was cleared by the drug regulator.
He also said that while the talks are on with the government on pricing and purchase agreements, the cost will be higher in the beginning but may come down later depending on the market conditions.
Ella said that his company is ready to roll out the vaccine, whose 50 lakh doses have been sent to the central drugs laboratory at Kasauli for testing, any day if the government allows it. “I would love to roll out tomorrow.”
The company said that it is confident about the high efficacy rate of its vaccine, given the tested nature of the platform(inactivated virus) it uses and robust immune response it showed in pre-clinical trials and early stage human trials. ens