Consent form for Covaxin assures compensation in case of adverse events

Representational Image
Representational Image

New Delhi, January 16 (PTI): Health workers who got their first shots of Covaxin at AIIMS on Saturday were made to sign a consent form that promised compensation in case of a "severe adverse event" related to the vaccine.

Covaxin has demonstrated the ability to produce antibodies against COVID-19 in phase one and phase two trials.

"However, the clinical efficacy is yet to be established and it is still being studied in phase 3 clinical trial," the form read.

Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed, it said.

Authorities said in case of any adverse event, the affected person will be provided medically-recognised standard of care in the government-designated hospitals.

"The compensation for a serious adverse event will be paid by sponsor (Bharat Biotech) if the SAE is proven to be causally related to the vaccine, the form read.

The recipients were also given a factsheet and a form to report adverse effects within seven days.

Those who received the first jabs of Covaxin after signing the form at AIIMs included Director Randeep Guleria and NITI Aayog member (health) Dr V K Paul, who is also head of an empowered group on medical equipment and management plan to tackle the coronavirus outbreak.

Indigenously developed Covaxin of Bharat Biotech was approved by India's drug regulator for restricted use in emergency situations in public interest, in clinical trial mode, especially in case of infection by mutant strains.

ICMR Director General Dr Balram Bhargava had earlier said that the clinical mode means that all those who would be administered Covaxin would give consent for the vaccine, there would be no placebo and there would be a closer follow up.