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Expert panel approves Covaxin for emergency use, waives off 'clinical trial mode'

The committee took the decision after taking into account the interim analysis of phase 3 clinical trials submitted by the company.

Published: 10th March 2021 08:51 PM  |   Last Updated: 10th March 2021 08:54 PM   |  A+A-

A health official shows Covaxin dose.

A health official shows Covaxin dose. (File Photo | Shekhar Yadav, EPS)

Express News Service

NEW DELHI: The Covid-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday approved Bharat Biotech's Covaxin for emergency use authorisation in India.

Two months ago, the vaccine's emergency use authorization was permitted only in the clinical trial mode.

The committee took the decision, said sources, after taking into account the interim analysis of phase 3 clinical trials submitted by the company.

"The recommendations of the SEC have been submitted to the Drug Controller General of India and the final decision is likely soon, " said a source. 

The Hyderabad-based vaccine maker in a press release few days back had said that its Covid19 vaccine had shown nearly 81 % efficacy in preventing the efficacy as per the early analysis of the results from the late-stage trials.

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While allowing the restricted use permission of Covaxin, country's first fully homegrown coronavirus vaccine, the DCGI in January had said that it can be rolled out only in clinical trial mode with "abundant caution" due to lack of efficacy data.

It meant that everyone who received the vaccine shot had to sign the detailed consent form at the vaccination site. The beneficiaries were also followed up more closely-- than beneficiaries for Covishield, the other vaccine which has been approved in India. 

"The waive off now to Covaxin will mean that both the approved vaccines will have the same status as its efficacy has been established now thrugh the initial analysis based on the first endpoint of the phase 3 trial," said a DCGI official.

The permission granted to Covaxin for its public use in the absence of phase 3 data had triggered criticism and had also resulted in vaccine hesitancy in thousands as many targeted beneficiaries were not comfortable in accepting a vaccine without proven efficacy.



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