Approved under the clinical trial mode, Bharat Biotech’s COVID-19 vaccine “Covaxin” was granted for restricted -emergency use. People who will get vaccinated have to sign a three- page form to give their consent.
Informed consent is the process before administering a healthcare intervention, of getting permission from the recipient.
This will also ensure proper monitoring regarding any serious side effects and it is the first vaccine to have such approval.
In the clinical trials of Phase 1 and Phase 2, the informed consent document has stated that Covaxin has exhibited the ability to produce antibodies against COVID-19.
Although, the clinical effectiveness is still in the procedure of Phase 3 clinical trial reason why it is essential to take an informed consent.
The informed consent basically collects information like name, gender, marital status, address of the clinic where the vaccine has been administered along with vaccinator’s details.
Also, there will be questions regarding your health like – are you feeling ill in the last 14 days, have come across any COVID patient in the last few months, do you have any chronic disease etc.
The recipient will be given enough time to go through the entire information consent before further decision. He/she will be free to ask any question regarding any of his/her query.
Consent should be taken in the presence of impartial witness, in case, if the recipient is illiterate.
Also, the patient/recipient will be provided medical care under government designated and authorized hospitals in case of any adverse emergency.
Bharat Biotech will be sponsoring the entire compensation for any kind of serious event if it is related to the vaccine.
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