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Consent Form Promises Compensation In Case Of Adverse Events Of Covaxin Shots

New Delhi: 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.

In the national capital, the COVID-19 vaccination exercise began at 81 centres with healthcare workers who have been in the forefront of the fight against the pandemic getting the shots first.

The 81 sites include six central government facilities — AIIMS, Safdarjung Hospital, RML Hospital, Kalawati Saran Children Hospital and two ESI hospitals.

The rest 75 centres, spanning all 11 districts of Delhi, include Delhi government-run facilities such as LNJP Hospital, GTB Hospital, Rajiv Gandhi Super Speciality Hospital, DDU Hospital, BSA Hospital, Delhi State Cancer Institute, ILBS Hospital, and private facilities such as Max Hospital, Fortis Hospital, Apollo Hospital and Sir Ganga Ram Hospital.

Oxford COVID-19 vaccine Covishield is being administered at 75 centres, while Covaxin is being given at the remaining six facilities.

Bharat Biotech To Pay Compensation If Covaxin Causes Adverse Effects

Bharat Biotech, which has received a government purchase order for supply of 55 lakh doses of Covaxin, will pay compensation to recipients in case of any ‘serious adverse’ effects experienced after receiving the antidote.

A consent form to be signed by the vaccine recipients said, “In case of any adverse events or serious adverse events, you will be provided medically recognised standard of care in the government designated and authorised centres and hospitals.”

“The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine,” the form said.

In phase 1 and 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against COVID-19.

However the clinical efficacy of the vaccine 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,” it added.

According to an industry expert, the company is liable to pay compensation to people in case of serious side effects caused by the vaccine administered while in the clinical trial mode.

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 caution, in clinical trial mode.

Meanwhile, Joint Managing Director of Bharat Biotech International Ltd, Suchitra Ella in her twitter account said, “Covaxin & Bharat Biotech is truly humbled & honoured to be of service to the nation & the fraternity of all first responders of covid who have served public health.”

Covaxin is a highly purified and inactivated two-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, the drug maker had said.

Covaxin is India’s totally indigenous COVID-19 vaccine developed in collaboration with the Indian Council of Medical Research and National Institute of Virology.

The inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility, one of its kind in the world.

(PTI)

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