Clarifying reports that the vaccine was permitted only for restricted use in an emergency situation under the clinical trial mode, Bharat Biotech said that "under this plan, the vaccine will be offered to the restricted prioritised groups only".
"The administration (of the vaccine) will take place under the clinical trial mode, which is different from the clinical trial as the effect of Covaxin will not be examined against any other intervention through this effort. You will be monitored for any adverse event under this clinical trial mode and supported for medical care under the existing public health programme."
Bharat Biotech also confirmed that the compensation for Serious Adverse Event will be paid by the company if the adverse event is proven to be causally related to the vaccine. "The compensation will be determined by the ICMR Central Ethics Committee, as appropriate."
Clarifying reports that the vaccine was permitted only for restricted use in an emergency situation under the clinical trial mode, Bharat Biotech said that "under this plan, the vaccine will be offered to the restricted prioritised groups only".
"The administration (of the vaccine) will take place under the clinical trial mode, which is different from the clinical trial as the effect of Covaxin will not be examined against any other intervention through this effort. You will be monitored for any adverse event under this clinical trial mode and supported for medical care under the existing public health programme."
Bharat Biotech also confirmed that the compensation for Serious Adverse Event will be paid by the company if the adverse event is proven to be causally related to the vaccine. "The compensation will be determined by the ICMR Central Ethics Committee, as appropriate."