Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.
India's first indigenously developed COVID-19 vaccine, Covaxin, will undergo strict evaluation in the wake of the Phase 3 trial data. Bharat Biotech, which developed the vaccine, announced on March 3 that Covaxin was 81 percent effective in preventing the infection after the third round of clinical trials.
The firm will submit the Phase 3 clinical trial data to the government in the coming days for review, LiveMint reported, citing a senior official at Central Drugs Standard Control Organisation (CDSCO).
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"Bharat Biotech is expected to submit the clinical trial data in 2-3 days. After the company submits the data, the Subject Expert Committee (SEC) will review and evaluate the data for granting it emergency use authorization, which is currently restricted to clinical trial mode," the official said, as per the report.
The government had approved Covaxin for restricted emergency use under clinical trial mode. Put simply, clinical trial mode means that a person will receive the vaccine after providing written consent and is followed up to see if the vaccine has caused any side-effects.
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"There is a rigorous assessment of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy, before emergency use authorization—which is aligned with global guidelines—is granted," the official said.
Covaxin demonstrated 81 percent interim efficacy in preventing COVID-19 in those without prior infection after the second dose, the company said in a statement.
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“Data from 25,800 participants received a vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well-tolerated,” the company said in a statement.
Krishna Ella, chairman and managing director of Bharat Biotech, said that the vaccine demonstrated significant immunogenicity against the rapidly emerging variants.Click here for Moneycontrol's full coverage of the COVID-19 outbreak