The central licensing authority has granted permission for the sale or distribution of Covaxin for restricted use in emergency situations in public interest as an abundant caution, in clinical trial mode
COVAXIN vaccine by Bharath Biotech.
Bharat Biotech, which has received a government purchase order for supply of 55 lakh doses of Covaxin, a COVID-19
vaccine, will pay compensation to recipients in case of any ‘serious adverse’ effects experienced after receiving the antidote. A consent form to be signed by the vaccine recipients said, “In case of any adverse events or serious adverse events, you will be provided medically recognised standard of care in the government designated and authorised centres and hospitals.”
“The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine,” the form said. In phase 1 and 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against COVID-19 . However the clinical efficacy of the vaccine is yet to be established and it is still being studied in phase 3 clinical trials.
“Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed,” it added.
According to an industry expert, the company is liable to pay compensation to people in case of serious side effects caused by the vaccine administered while in the clinical trial mode.
The central licensing authority has granted permission for the sale or distribution of Covaxin for restricted use in emergency situations in public interest as an abundant caution, in clinical trial mode.
Meanwhile, Joint Managing Director of Bharat Biotech International Ltd, Suchitra Ella in her twitter account said, “Covaxin & Bharat Biotech is truly humbled & honoured to be of service to the nation & the fraternity of all first responders of covid who have served public health.” Covaxin is a highly purified and inactivated two-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, the drug maker had said.
Covaxin is India’s totally indigenous COVID-19 vaccine developed in collaboration with the Indian Council of Medical Research and National Institute of Virology. The inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility, one of its kind in the world.
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