Covaxin consent form says vax administered without ph-3 trial


New Delhi, Jan 16 (IANS): Amid the vaccination 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 a 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 casualty 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 comes 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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Comment on this article

  • Sunil K, Mangalore

    Sat, Jan 16 2021

    Phase 3 untested vaccines for South India. Is it discrimination ?

    If anything goes wrong, Bharat Biotech will pay competition ONLY if you can provide 100% proof that it was due to their vaccine - That's a BIG joke after playing with the lives of people.

    DisAgree Agree [8] Reply Report Abuse

  • annu, mlore

    Sat, Jan 16 2021

    Why our Politicians and leaders not taking COVAXIN and why they are not taking initiative to encourage common people to take the same vaccine????????? In other countries many leaders have taken Covid 19 Vaccine as an example? Why not our leaders???

    DisAgree [1] Agree [10] Reply Report Abuse


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Title: Covaxin consent form says vax administered without ph-3 trial



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