Covid-19 vaccination in India: Bharat Biotech’s vaccine recipients asked to sign consent forms

As India today began vaccinating its people against coronavirus, those receiving Bharat Biotech’s Covaxin were asked to sign consent forms which held out the assurance of compensation and treatment if any adverse effect was noticed linked to the jab.

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Since the phase 3 human trial mode of Covaxin is still in progress, persons receiving the jab today were asked to sign the two-page consent forms, reports our New Delhi correspondent.

“The Bharat Biotech Covid-19 vaccine (Covaxin) is a vaccine with approval for restricted use in emergency situation that may prevent Covid-19,” the consent form read. 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 consent form said.

It further said that “in case of any serious adverse events, vaccine recipients will be provided medically recognised standard of care in the government designated and authorised centres/hospitals.

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The compensation for the serious adverse event will be paid by sponsor (Bharat Biotech India Ltd) if the serious adverse event is proven to be related to the vaccine. The compensation will be determined by the Indian Council of Medical Research’s Central Ethics Committee as appropriate.

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