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The consent form for Covaxin ensures compensation in case of adverse events | India News

NEW DELHI: Healthcare workers who received their first Covaxin injections at AIIMS on Saturday were required to sign a consent form that promised compensation in the event of a vaccine-related “serious adverse event.”
Covaxin has demonstrated the ability to produce antibodies against Covid-19 in phase one and phase two trials.
“However, clinical efficacy has not yet been established and is still being studied in a phase 3 clinical trial,” the form said.
So it’s important to note that getting the vaccine doesn’t mean you don’t need to follow other Covid-19-related precautions, he said.
Authorities said that in the event of any adverse event, the affected person will receive a recognized standard of medical care at government-designated hospitals.
“Compensation for a serious adverse event will be paid by the sponsor (Bharat Biotech) if the SAE is shown to be causally related to the vaccine,” the form read.
Beneficiaries also received a fact sheet and a form to report adverse effects within seven days.
Those who took the first hits from Covaxin after signing the form at AIIMS included director Randeep Guleria and NITI member Aayog (health), Dr. VK Paul, who also leads an empowered group on medical equipment and management plan for address the coronavirus outbreak.
The indigenously developed Bharat Biotech Covaxin was approved by the Indian drug regulator for restricted use in public interest emergency situations, in clinical trial mode, especially in case of infection by mutant strains.
ICMR CEO Dr. Balram Bhargava had previously said that the clinical mode means that everyone who would be given Covaxin would consent to the vaccine, there would be no placebo and there would be closer follow-up.
In the national capital, the Covid-19 vaccination exercise began in 81 centers with health workers who have been at the forefront of the fight against the pandemic by receiving the first vaccines.
The 81 sites include six central government facilities: AIIMS, Safdarjung Hospital, RML Hospital, Kalawati Saran Children Hospital, and two ESI hospitals.
The remaining 75 centers, spanning all 11 districts of Delhi, include Delhi government-run facilities such as LNJP Hospital, GTB Hospital, Rajiv Gandhi Super Specialty 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.
The Oxford Covid-19 Covishield vaccine is administered at 75 centers, while Covaxin is administered at the remaining six facilities. in

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