'Compensation in case of adverse events', says Covaxin consent form as India starts COVID-19 vaccination drive
New Delhi | Jagran News Desk: As India began its pan-country vaccination drive against the deadly coronavirus today, Indian vaccine developer Bharat Biotech, whose vaccine candidate, Covaxin, was among the two vaccines given the emergency use authorisation by the government, has asked the beneficiaries of its vaccine to sign a consent form that gives the beneficiaries an assurance that if they face any serious adverse effect due to the vaccine they will be given the compensation for it.
The consent form further states that the beneficiaries will be provided with proper care in the government-designated and authorized hospitals if in case any side effect occurs due to the vaccine. In its consent form, Bharat Biotech said 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.
What does the consent form of Bharat Biotech's Covaxin say?
In the form, it is mentioned that the beneficiaries need to sign the consent form before getting vaccinated as the use of this vaccine has been allowed by the government in clinical trial mode. The form reads, "COVAXINTM" says that the vaccine is being used under an emergency situation and it has been permitted in the public interest for the precaution. It also reads that this vaccine is still in the Phase 3 trials.
The form further states, "the clinical efficacy of COVAXIN is yet to be established and it is still being studied in phase 3 clinical trial."
"In case of any adverse events or serious adverse events, you will be provided a medically recognized standard of care in the government designated and authorized centers/hospitals. The compensation for the serious adverse event will be paid by the sponsor (BBIL) if the (adverse effect) is proven to be causally related to the vaccine, the form states.
The declaration reads, "I emphasize that any information provided by me before taking the vaccine will be saved in the database maintained by the immunization program of the government and the privacy as well as the confidentiality of the information provided by you will be maintained."
However, on the other hand, there is no such consent form for the Covishield vaccine, which is developed by the University of Oxford and pharma major AstraZeneca and manufactured by Serum Institute of India (SII). Adar Poonawala, Chief Executive Officer, SII has also said that this vaccine is highly effective against coronavirus and it can be considered as one of the most promising vaccines for India where cost plays a major role.
Earlier, today Prime Minister Narendra Modi launched the world's largest Covid-19 vaccination drive via a video conference in which he addressed 3,006 centers across India where the first shots of the vaccines are to be given. The government is planning to vaccinate around 3 lakh healthcare workers on the first day of the inoculation drive and three crore frontline workers in phase one.
The world's biggest vaccination drive has 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 over one crore people.
Posted By: Deeksha Sharma