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‘Bharat Biotech vaccine approved in clinical trial mode, consent must be taken from participants’: ICMR


Balram Bhargava, head of the Indian Council for Medical Research (ICMR), said on Tuesday that Bharat Biotech’s Covid-19 vaccine has been approved in clinical trial mode, which means consent must be obtained from participants. It answers the questions that are raised about the authorization granted to Covaxin.

“Permission for restricted use has been allowed in clinical trial mode, which means consent must be obtained from the participants and there must be regular follow-up of the participants,” Bhargava said at a news conference on Tuesday.

Explaining the process followed to grant approval to the AstraZeneca-Oxford University Covid-19 vaccine and the indigenously developed Covaxin, Bharagava said: “The subject matter expert committee (SEC) considered the existing pandemic situation, the high mortality, the available science, and the lack of definitive treatments. on Covid-19 from CDSCO for granting expedited approval to these vaccines, and that is in our legal provision. “

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

Industry experts and some opposition leaders have raised concerns about the absence of phase 3 trial data on Covaxin. Critics have warned that “circumventing” the process and giving a “premature” authorization could put lives at risk and raise questions about vaccines in India.

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

Meanwhile, the Union Health Ministry said Tuesday that it is prepared to launch the Covid-19 vaccine in 10 days, but a final decision on the launch date has yet to be made.

“According to comments from the dry vaccination campaign, the health ministry is ready to introduce the Covid-19 vaccine within 10 days of the emergency use authorization date,” said the Union’s health secretary. , Rajesh Bhushan.

He also said that healthcare and frontline workers do not need to register for the vaccination campaign as their database has been uploaded to the CoWIN vaccine administration management system in bulk.

(With inputs from agencies)

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