Covaxin recipients asked to sign consent form on ‘clinical trial mode’

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India began its COVID-19 vaccination drive on Saturday with two approved vaccinations Serum Institute of India’s Covishield — developed by Oxford-AstraZeneca and Bharat Biotech’s Covaxin. Those receiving Bharat Biotech’s Covaxin have been asked to sign a consent form before being vaccinated as the vaccine “has been allowed by the government in clinical trial mode”.

The screening and consent form adds that compensation for serious adverse events will be paid by the company if it is proven to be causally related to the vaccine.

“The clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trials. 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 Central Licensing Authority has granted permission for the sale or distribution of Covaxin for restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode,’’ notes the form.

Ability to produce antibodies 

It, however, states that in phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against COVID-19.

The declaration says: “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.”

The recipients will be handed over a fact sheet and a form to report adverse effects, in which they have to note down symptoms like fever, pain within seven days.

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Currently beneficiaries don’t have a choice of vaccine and several Central government hospitals in Delhi — AIIMS, Safdarjung, Ram Manohar Lohia hospital, Kalawati Saran Children Hospital — administered Covaxin to its staff under the first round of vaccination. 

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