Consent form mandatory for Covaxin shot

Consent form mandatory for Covaxin shot

17/01/2021

special correspondent NEW DELHI

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 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 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 Covaxin for restricted use in emergency situations in public interest... in clinical trial mode,” the form says