Before being vaccinated, recipients of Covaxin have to sign a consent form. This is because the Bharat Biotech vaccine has been allowed by the government in “clinical trial mode”.
As India started its vaccination drive against Covid-19 on Saturday, with frontline workers being administered the vaccine shots in the first round, those receiving Bharat Biotech’s Covaxin were asked to sign consent forms that assured compensation if any adverse effect was found linked to the vaccine. However, there was no detailed explanation of the process of compensation in case of an adverse event.
Before being vaccinated, recipients of Covaxin have to sign a consent form. This is because the Bharat Biotech vaccine has been allowed by the government in “clinical trial mode”.
The consent form says “COVAXINTM” is being offered under restricted use in an emergency situation and has been permitted in “public interest” as an abundant precaution. The consent form explains that the clinical efficacy of Covaxin is yet to be established and is still being studied in phase 3 clinical trials.
“The Bharat Biotech COVID-19 Vaccine (COVAXINTM) is a vaccine with approval for restricted use in emergency situation that may prevent COVID-19. In phase 1 and phase 2 clinical trials, COVAXINT 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 reads.
“In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in the government designated and authorized centers/hospitals. The compensation for serious adverse event will be paid by sponsor (BBIL) if the (adverse effect) is proven to be causally related to the vaccine,” the form states further.
“I further emphasize that any information provided by me prior to taking the vaccine will be archived in the database maintained by the immunization program of the government and privacy as well as confidentiality of the information provided by you will be maintained,” says the declaration of the form.
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