As the vaccinaton drive against Covid-19 began on Saturday, those taking 'COVAXIN' vaccine manufactured by Bharat Biotech are asked to sign a separate consent form, acknowledging that the jab is being administered without the phase-3 trial.
Frontline and healthcare workers are taking the vaccine jab in the first phase and they were asked to sign consent forms before the shot as the use has been allowed by the government in "clinical trial mode". The form assured compensation if any adverse effect was found linked to the vaccine.
"The Bharat Biotech COVID-19 Vaccine is a vaccine with approval for restricted use in emergency situation that may prevent COVID-19. 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," the form says.
The consent form says that in case of any adverse and serious condition, the receiver will be provided utmost care at the health centre and the compensation will be provided by Bharat Biotech in case of casuality.
"The compensation for serious adverse event will be paid by sponsor BBIL if the SAE is proven to be casually related to the vaccine," it said.
The Drugs Controller General of India (DCGI) had earlier this month approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
This will be the world's largest vaccination programme covering the entire length and breadth of the country.
According to the government, the shots will be offered first to an estimated one crore healthcare workers and around two crore frontline workers, and then to persons above 50 years of age, followed by persons younger than 50 years of age with associated comorbidities.
The cost of vaccination of healthcare and frontline workers will be borne by the central government.
So far, the central government has procured 1.1 crore Covishield and 55 lakh Covaxin vaccines at a cost of Rs 200 and Rs 206 per dose, respectively.