Covaxin is 200% safe, says Bharat Biotech Chairman

Hyderabad: Covaxin, the indigenous vaccine developed by Bharat Biotech against COVID-19 in collaboration with ICMR, is 200 per cent safe, company’s Chairman and Managing Director Dr Krishna Ella has said and noted that it has shown less than 10 per cent adverse reaction in trials so far.

“Covaxin has shown less than 10 per cent adverse reactions, while others have 60 per cent to 70 per cent adverse reactions. I can assure our vaccine is 200 per cent safe,” Dr Ella said on Monday in a press conference via video conferencing.

His remarks came a day after DGCI granted permission for restricted emergency use of Covaxin.

The indigenous vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

Amid remarks by a few political leaders that the vaccine has been granted permission without completion of phase 3 trials, he said Central Drugs Standard Control Organisation (CDSCO) 2019 clearly state that “if yours is a proven platform technology, safe platform technology, and good pre-clinical trial data is available then you can get the emergency license for the product”.

On remarks that Covaxin is a “back-up vaccine”, he said “it is a vaccine, and not a backup” and added that “people should be responsible before making such statements.”

“Currently, we have 20 million doses. We are aiming to achieve 700 million doses capacity in four facilities — three in Hyderabad and one in Bengaluru. We are encountering so many problems including related to logistics,” he said.

“We will roll out the vaccine as early as possible. Batches have been sent to Kasauli government testing lab already,” he added.

Bharat Biotech had said in a release earlier that Covaxin is a highly purified and inactivated two-dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.

COVID-19 vaccines of Serum Institute of India and Bharat Biotech were granted permission for restricted use in an emergency situation by the Drugs Controller General of India (DCGI) on Sunday.

Some Congress leaders have criticised the government for emergency use authorisation given to COVID-19 vaccines without completion of phase 3 trials.