What does the Covaxin consent form say?

The Hyderabad-based Bharat Biotech said they would compensate patients who face 'adverse effects' after receiving the vaccine

As India kicked off the world's largest vaccination drive on Saturday, healthcare and frontline workers due to receive Bharat Biotech's Covaxin antiviral shot were made to sign a consent form.

The text, boldened and underlined the part stating that the Hyderabad-based group would compensate patients who face 'adverse effects' after receiving the vaccine.

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"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 stated.

Read | Delhi sees one severe adverse event, 51 mild ones on day 1 of Covid-19 vaccination drive

Manish Kumar, a hospital worker at the All India Institute of Medical Sciences (AIIMS) was the first person in India to receive a vaccine against the coronavirus. The 34-year old was given the Covaxin vaccine.

All recipients of the Bharat Biotech-made vaccine are made to sign a consent form as the Covaxin was approved by the Drugs Controller General of India (DCGI) before it had even completed its phase 3 trials, let alone clinical trials.

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"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 stated.

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At the bottom of the page, the declaration stated that data provided by the signatory would be stored in the government's immunisation program database, and would remain confidential.

"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."

(With agency inputs)