Covaxin Has Excellent Safety Data, Says Bharat Biotech Chairman
Mumbai: Indigenous vaccine Covaxin is 200 per cent safe against COVID-19 developed by Bharat Biotech in collaboration with ICMR, the company’s Chairman and Managing Director, Dr Krishna Ella said that it showed less than 10 adverse reactions in the trial.
Dr Ella said in a video conferencing press conference on Monday, “Covaxin has shown less than 10 per cent adverse reactions, while others have 60 to 70 per cent adverse reactions. I can assure you that our vaccine is 200 per cent safe.”
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His remarks came a day after DGCI allowed restricted emergency use of covaxin.
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Indigenous vaccines have been developed by Biotech of India in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
According to the remarks of some political leaders that the vaccine has been allowed without completion of Phase 3 trials, he said that the Central Drugs Standard Control Organization (CDSCO) 2019 explicitly stated that “if you are a proven platform technology, Secure platform technology, and good pre-clinical trial data is available so you can get an emergency license for the product.”
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On the comment that covaxin is a “back-up vaccine”, he said that “it is a vaccine, and not a backup” and added that “people should be responsible before making such a statement.”
“Currently, we have 20 million doses. We aree aiming to achieve 700 million dose capacity at four facilities – three in Hyderabad and one in Bengaluru. We are facing a lot of logistics-related problems,” he said.
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“We will roll out the vaccine as early as possible. Batches have been sent to Kasauli government testing lab already,” he added.
Bharat Biotech previously stated in a release that covaxin is a highly purified and inactive two-dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of over 300 million doses.
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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.
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