What does the consent form that must be signed by Covaxin recipients say?
New Delhi, Jan 16: The consent form that must be signed by Covaxin beneficiaries states that its efficacy is yet to be established. It assures compensation by Bharat Biotech in case of a serious adverse event that is proven to be causally related to the vaccine. It further states that beneficiaries would be provided care in government-designated facilities if they suffer any adverse events.
The form read that only phase 1 and 2 trials have been completed, and that phase 3 is still on.
"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. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed."
"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 centers/hospitals," it adds.
For those receiving Covaxin, their health status will be examined and scrutinised before giving the vaccine and after vaccination they will be monitored for seven days for any adverse events. Similar process will be followed after the second dose which will be given after four weeks.
Authorities have said that both Covishield and Covaxin approved for emergency use by Drug Controller General of India (DCGI) were safe and that there is no need for apprehension.