When Covaxin's “emergency use” was approved by the government, it was done under “clinical trial mode”
Hyderabad: The administration of 55 lakh doses of Covaxin, the Bharat Biotech vaccine ordered by the Centre as part of the Covid-19 vaccination drive, could well mean that a massive government-mandated trial is underway for the vaccine is that is yet to officially complete its Phase III trials.
When its “emergency use” was approved by the government, it was done under “clinical trial mode”. What this meant became evident on Saturday when those receiving the vaccine in several states according to media reports, were asked to sign a consent form agreeing to be part of such a clinical trial.
In the consent form, Bharat Biotech says the vaccine is being offered in a clinical trial mode and that in Phase I and II of the trials the vaccine demonstrated ability to produce antibodies to Covid-19. “However, the clinical efficacy is yet to be established and it is still being studied in phase 3 clinical trial,” the form read.
Telangana state Director of Health Services Dr G. Srinivasa Rao said that Covaxin was not used in the state on Saturday, and Serum Institute of India's Covisheild was administered to frontline workers. He had said on Friday said that anyone receiving Covaxin will be monitored closely for seven days after vaccination.
When a reporter asked him if Covishield recipients too would be monitored like Covaxin recipients, he said as per the existing protocol, this was not required.
Elsewhere, managing director of Bharat Biotech International Ltd., Suchitra Ella Tweeted: "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."
A PTI report from Delhi said health workers who got their first shots of Covaxin at AIIMS were made to sign the consent form that promised compensation in case of a “severe adverse event” related to the vaccine.
“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.
Authorities said in case of any adverse event, the affected person will be provided medically-recognised standard of care in the government-designated hospitals, according to PTI. The recipients were given a factsheet and a form to report adverse effects within seven days.