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Bharat Biotech’s Covaxin gets approval for restricted emergency use and waived clinical trial conditions

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation has recommended Bharat Biotech’s Covaxin for emergency use in India.
Previously, the vaccine’s emergency use was sanctioned only in the clinical trial mode. This has now been abandoned by the SEC . The interim data of Covaxin’s Phase-3 trial has shown 81 percent efficacy and this has lead to the new decision of waiving the clinical condition.

Being the first indigenous vaccine against the Covid-19 of India, Covaxin which is developed and manufactured by Bharat Biotech has thus achieved the waiving. Covishield, the other vaccine, manufactured in India by the Pune-based Serum Institute of India was developed by Oxford University and AstraZeneca.Both the vaccines are administered in two dose.

Earlier, Bharat Biotech has published the results of Phase 3 clinical trials of Covaxin, declaring the vaccine shows interim clinical efficacy of 81 percent.
The Phase 3 clinical trials involved 25,800 volunteers, making it the “largest trials ever conducted in India” in collaboration with the Indian Council of Medical Research (ICMR), Bharat Biotech said.
“Covaxin has demonstrated 81 percent interim efficacy in preventing Covid-19 in those without prior infection after the second dose,” it said, figuring that furthermore, demonstrating high clinical efficacy against Covid-19, the vaccine also provides “significant immunogenicity against the rapidly emerging variants” of the virus causing Covid-19.

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