Bharat Biotech vaccine approved in clinical trial mode, consent of participants has to be taken: ICMR

Balram Bhargava, chief of Indian Council of Medical Research (ICMR), said on Tuesday that Bharat Biotech’s Covid-19 vaccine has been cleared in the clinical trial mode, which means consent of participants has to be taken. He was responding to the questions being raised on the clearance given to Covaxin.

“Permission for restricted use in clinical trial mode has been allowed which means consent of participants has to be taken and there has to be a regular follow up of participants,” Bhargava said at a press conference on Tuesday.

Explaining the process followed in granting nod to AstraZeneca-Oxford University’s Covid-19 vaccine and indigenously developed Covaxin, Bhargava said, “The existing pandemic situation, high mortality, available science and lack of definitive treatments were considered by the subject expert committee (SEC) on Covid-19 of CDSCO for granting accelerated approval to these vaccines, and that is in our legal provision.”

The Drugs Controller General of India (DCGI) had on Sunday approved AstraZenca’s vaccine Covishield, manufactured by the Serum Institute, and Covaxin for restricted emergency use in the country, paving the way for a massive inoculation drive.

Industry experts and some opposition leaders have expressed concern over the absence of Phase 3 trial data on Covaxin. The critics have cautioned that “sidestepping” processes and giving “premature” clearance could risk lives and fuel vaccine hesitancy in India.

“In a pandemic situation, restricted use is considered based on safety and immunogenicity data while phase three clinical trail is still ongoing. The immunogenicity data generated through phase two clinical trial serves as a surrogate for efficacy. The Clinical Trial Rule, 2019, provides for considering phase two results to guide approval. Now the SEC guides the DCGI in the process of decision making for restricted use under emergency situation. Now we have two vaccines,” Bhargava said.

The Union health ministry, meanwhile, said on Tuesday that it is prepared to roll out Covid-19 vaccine within 10 days, but a final decision on the launch date is yet to be taken.

“Based on the feedback from the dry-run of vaccination drive, the health ministry is ready to introduce Covid-19 vaccine within 10 days from the date of emergency use authorisation,” Union health secretary Rajesh Bhushan said.

He also said that healthcare and frontline workers need not register themselves for the vaccination drive as their database has been uploaded on the CoWIN vaccine delivery management system in a bulk.