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COVAXIN Phase – 3 Trials shows 81% efficacy

India’s homegrown indigenous vaccine has shown 81% efficacy in phase-3 clinical trials. The phase – 3 clinical trials was conducted on 25,800 participants who received a vaccine or placebo in a 1:1 ratio.

“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants.COVAXIN®️ demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” said Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech.

 BBV152 contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. It is stable at 2 to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels. BBV152 has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30%.

 BBV152 is based on an established manufacturing platform with a better safety profile when compared to other vaccine platforms. The inclusion of the Algel-IMDG adjuvant enhances T-cell immune responses to COVID-19, leading to long-term protection.

 “I want to thank every one of the participants, who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery,” said Mrs. Suchitra Ella, Joint Managing Director, Bharat Biotech. “We could not have achieved this public-private partnership milestone without the relentless commitment of those involved.”

“Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication.” Says the statement released by Bharat BioTech

Dr. Krisha Ella’s Video byte – https://we.tl/t-WEbutiiBiE
Mrs. Suchitra Ella’s video byte -https://we.tl/t-oXp0kbXXJx

Medically Speaking Team

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