The Hyderabad based pharma company, Bharat Biotech International Private limited agreed to pay compensation if shows adverse side effects on people.
Vaccine recipients receiving Bharat Biotech manufactured COVAXIN, would have to sign a consent form before they take the jab.
The decision was taken to sign consent as the clinical efficacy of COVAXIN is yet to be established. Bharat Biotech manufactured COVAXIN is under phase three trial, hence the efficiency is questionable as of now.
The Central Government gave permission for administering COVAXIN, even though the clinical trials for the vaccine were in the phase 3 stage.
In regard to this, the beneficiaries have been promised medical care and compensation in case of adverse side effects.
The statement from Bharat Biotech International Private limited said, ” The compensation for the serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to the vaccine. The compensation will be determined by the ICMR Central Ethics Committee.”
The Drugs Controller General of India (DCGI) approved COVAXIN and Covishield of the Serum IInstitute of India (SII) for Emergency Use Authorisation (EUA) and vaccination drive.
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