Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.
The Indian Council of Medical Research (ICMR) has said that the recipients of Covaxin will be monitored for three months after getting the second dose for any adverse reactions.
The ICMR stated this in a detailed plan, according to which if a serious adverse event is linked to vaccination, then the recipient will be compensated, reported Hindustan Times.
The compensation will be based on the national drug controller’s recommendations after a thorough investigation, said the report.
According to the document, the beneficiaries will have to document their health condition in writing and submit the form to health authorities for seven days after taking each dose of the vaccine.
“Day 1-7: The vaccine recipients will be given an adverse event form to record the adverse events. Day 8-27: The vaccine recipients will inform the vaccination site, if they have encountered any health-related issues or adverse events. The vaccine recipients will return the adverse event form during the visit for the administration of the second dose of vaccine (Day 28),” the report stated citing the document.
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After administration of the second dose of Covaxin, the recipients will be given an adverse event form to record the adverse events for the next seven days.
“The vaccine recipients will inform the site, if they have encountered any health-related issues or adverse events. Vaccine recipients will return the filled-in adverse event reporting form after completion of 7 days post-vaccination,” the document said.
The paper further mentioned that “all the vaccine recipients will be followed-up for a period of 3 months after the second dose of vaccination.”
Covaxin is India's totally indigenous COVID-19 vaccine developed in collaboration with the ICMR and the 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.
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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.
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.
(With inputs from PTI)Follow our full coverage on COVID-19 here.