Covaxin consent form says vaccine administered without Phase 3 trials

Photo for representational purpose

Amid the vaccinaton drive against Covid-19, it has emerged that there is a separate consent form for those who are administered the 'Covaxin' vaccine manufactured by Bharat Biotech.

The form says that "In phase-1 and phase-2 clinical trial '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 the other precautions related to Covid-19 should not be followed."

The form says that in case of any adverse and serious condition, the receiver will be provided utmost care at the health centre and in case of casuality the compensation will be provided by Bharat Biotech.

"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.

Serious concerns were raised in certain quarters including by opposition parties and Congress leader Manish Tewari has questioned the efficacy of 'Covaxin' while the Prime Minister has warned people not to believe in "rumours".

The world's biggest vaccination drive come almost a year after the first coronavirus case was detected in India, and since then the deadly virus has claimed over 1.5 lakh lives and infected one crore people. The first case came to the fore on January 30, 2020 in Kerala.

Two vaccines -- the Oxford vaccine 'Covishield' manufactured by the Serum Institute of India, and indigenously developed 'Covaxin' by Bharat Biotech -- will be administered to priority groups. 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.

In Delhi, which has 81 vaccination sites, 'Covaxin' has been allotted to six Centre-run hospitals while 75 Delhi government and private hospitals will receive 'Covishield'.

The vaccine is first offered to the healthcare workers, frontline workers and those above 50 years of age, followed by the below-50 population with comorbidities, and finally to the remaining population based on disease epidemiology and vaccine availability.

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