Covaxin's Restricted Use Considered Based On Safety, Immunog
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Balram Bhargava, chief of Indian Council of Medical Research (ICMR), said 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 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.”

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 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.

Source:
https://www.hindustantimes.com/india-news/bharat-biotech-vaccine-approved-in-clinical-trial-mode-consent-of-participants-has-to-be-taken-icmr/story-NSWVTh7douMtYDl1ZVnP6K.html
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