Bharat Biotech’s Covaxin was granted restricted emegency use approval in ‘clinical trial mode’ on January 2.
Bharat Biotech’s COVID-19 vaccine Covaxin was granted restricted emergency use approval under clinical trial mode, which means that people who receive the vaccine will have to sign a three-page informed consent form, and will also be monitored for any serious side effects. This was first such approval given to a vaccine in India.
What is an informed consent?
An informed consent is the process of getting permission from the recipient before administering an healthcare intervention, in this case the Covid-19 vaccine.
Why the Covaxin is administered in a clinical trial mode?
The informed consent document says that in phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against COVID-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trial. So it was imperative for taking informed consent.
What information is sought from the recipient?
The informed consent takes information such as name, date of birth, gender, marital status, address, registration number, phone numbers, it also contains name and address of clinic site where vaccine is administered and name and contact details of the vaccinator supervising your vaccination. In addition there will be questions like are you feeling sick; in the last 14 days, have had a COVID-19 test or been told by a health care provider to isolate or quarantine at home due to COVID-19 infection or exposure; have you been treated with antibody therapy in last 3 months, do you have severe allergic reactions; are you pregnant or planning to becoming pregnant or nursing mother, any long standing disease; or taking radiation therapy.
How can one learn more about the vacccine before signing consent?
The person should ask the vaccinator or officer supervising your vaccination, or he should visit the website.
Will one be given time to read the document?
The vaccine receipent will be provided sufficient time to read, or have to be explained about the fact sheet about the vaccine. He will also be allowed ask questions which have to answered to his satisfaction. Following the understanding of the benefits and risks of the vaccination, the person will give his consent.
What if the vaccine recipient is illiterate?
If vaccine recipient is illiterate, consent should be taken in the presence of impartial witness. The witness will also have to sign the informed consent.
Will I be provided care in case of any adverse events (AE) or serious adverse events (SAE)?
In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in the government designated and authorized hospitals.
Who pays compensation for the SAE?
The compensation for serious adverse event will be paid by sponsor Bharat Biotech if the SAE is proven to be causally related to the vaccine.