Bharat Biotech to pay compensation if Covaxin causes side effects

By Press Trust of India|16th Jan 2021
In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against COVID- 19.
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Bharat Biotech, which has received a government purchase order for supply of 55 lakh doses of Covaxin, a COVID-19 vaccine, said the company will pay compensation to recipients in case of any serious adverse effects experienced after receiving the antidote.


In the consent form to be signed by the vaccine recipients, Bharat Biotech 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/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 consent form said.

In phase 1 and phase 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, the vaccine maker said.

"Hence it is important to appreciate that receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed," the consent form said.

According to an industry expert, the company is liable to pay compensation to people in case of serious side effects as the vaccine is being 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 BharatBiotech International Ltd, Suchitra Ella in her twitter account said, "Covaxin & Bharat Biotech is truly humbled & honoured to be of service to the nation and the fraternity of all first responders of Covid who have served public health."


(Disclaimer: Additional background information has been added to this PTI copy for context)

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