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This article is more than 6 month old.

Bharat Biotech plans Covaxin Phase 4 trials, says will meet 'every scientific standard'

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Bharat Biotech will conduct Phase 4 trials of Covaxin to check its 'real-world effectiveness.' Its Phase 3 data is slated to be made public in July, after which it will apply for full licensure.

Bharat Biotech plans Covaxin Phase 4 trials, says will meet 'every scientific standard'
Hyderabad-based vaccine maker Bharat Biotech will conduct phase four trials of its indigenously developed COVID-19 vaccine, Covaxin, to check its real-world effectiveness. The pharma company plans to apply for full licensure of Covaxin after the final analysis of its phase three trial data, which will be made public next month.
"Bharat Biotech is also doing phase four trials to check on the real-world effectiveness of the vaccines, and to ensure its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorisation," news agency ANI quoted the company.
"It is critical to understand, and further emphasise the Phase 3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of three months for publication, and as communicated earlier, Covaxin phase 3 results full trial data will be made public during July. Once data from the final analysis of Phase 3 studies are available, Bharat Biotech will apply for full licensure for Covaxin," Bharat Biotech told ANI on June 9.
"Whole virus inactivated vaccines have demonstrated one of the best safety records globally," Bharat Biotech said.
In a recent preliminary pre-peer-reviewed study about vaccine efficacy report, Bharat Biotech has clarified that it has undergone and will continue to undergo the most intensive safety and efficacy monitoring in the history of Indian vaccines.
The statements come in the wake of a Twitter spat between Bharat Biotech’s Dr Raches Ella and Kolkata-based endocrinologist Dr Awadhesh Kumar Singh over the latter’s study comparing immune responses of Covaxin and Serum Institute's Covishield.
On the efficacy of the vaccine, Bharat Biotech said, "Vaccine efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals in a defined population under ideal conditions of use. When it comes to efficacy and safety, the overall efficacy of Covaxin is 78 percent and efficacy against hospitalisations is 100 percent."
The government on June 8 had placed fresh orders for 19 crore vaccine doses of Covaxin. Covaxin is being manufactured in collaboration with ICMR and National Institute of Virology (NIV).
 
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