Mutual Funds Commodities Research Tax Planning IPO Our Team Contact Us  
Google
Web www.equitybulls.com
Stock Report

| More

Bharat Biotech Announces Phase 3 Results of COVAXIN®: India's First COVID-19 Vaccine Demonstrates Interim Clinical Efficacy of 81%

Posted On: 2021-03-03 08:55:31 (Time Zone: Arizona, USA)


Bharat Biotech, a global leader in vaccine innovation, developing vaccines for infectious diseases, today announced the first interim analysis of its BBV152 (COVAXIN®). The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.

"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."

Interim Phase 3 Results: 81% Efficacy

The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the BBV152 (COVAXIN®) group, resulting in a point estimate of vaccine efficacy of 80.6%.

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial's conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA.

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv. https://doi.org/10.1101/2021.01.26.426986

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.

More than 40 countries globally have expressed their interest in COVAXIN®. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity.


Source: Equity Bulls

Click here to send ur comments or to feedback@equitybulls.com


Other Headlines:

IIFL Securities Limited to acquire Category II AIF from IIFL Wealth Management Ltd

HDFC Bank Limited to raise up to Rs. 50,000 crore

Indo Asian Finance Ltd to consider allotment of 60 lakh shares on April 20, 2021

KEC International Limited Resumption of WKTL Transmission Project

IIFL Wealth Management Ltd to sell AIF Category-II business to IIFL Management Services Ltd

International Travel House Ltd Q4FY21 loss at Rs. 6.70 crore

Gujarat Hotels Ltd Q4FY21 net profit slides YoY, QoQ

ICICI Lombard General Insurance Company Limited board recommends final dividend of Rs. 4

Gujarat Hotels Ltd board recommends dividend of Rs. 1.80 for FY21

ICICI Lombard General Insurance Company Ltd reports Rs. 345.68 crore PAT in Q4FY21

HDFC Bank Ltd's gross NPAs at 1.32%, reduces QoQ

HDB Financial Services Ltd's gross NPAs at 3.9% as of March 31, 2021

HDFC Securities Ltd reports PAT of Rs. 253.1 crore in Q4FY21

Career Point signed MOU with Ministry of Social Justice and Empowerment for tutorial services

HDFC Bank's balance sheet increases 14.1% YoY

Indiamart arm to acquire 22% in Truckhall Pvt Ltd

HDFC Bank Ltd Q4FY21 consolidated net profit slips QoQ to Rs. 8433.78 crore

CRISIL downgrades rating of PVR Ltd

Hatsun Agro Product Ltd board to consider FY21 results on April 27, 2021

Choice International Limited allots 34,49,989 Equity Shares on Conversion of Warrants

Adani Renewable Energy Holding Fifteen Ltd receives 159 MWac solar power project

Coforge Limited board approves issue of NCDs for Rs. 340 crore

Glenmark Life Sciences Ltd files DRHP with SEBI for IPO

KDDL Limited extends rights issue closure date to May 3, 2021

SG Shinagawa Refractories India Private Limited commences commercial operation

Prestige Estates Projects Limited acquires stake in companies having land bank in North Bangalore

ABB Power Products and Systems India Ltd board to announce Q1CY2021 results on May 5, 2021

GE Power India Limited signs SPA with GE Power Systems GmbH

Carborundum Universal Ltd board to approve final dividend and FY21 results on April 28, 2021

PNB Housing Finance Ltd board to consider FY21 results, dividend and NCD issue on April 27, 2021

ESAF Small Finance Bank raises Rs 162 Cr through preferential allotment

Everything Summer - Bahamas launches new Spring Summer collection 2021

MCX and Nihilent Technologies partners with Times OOH

44 meritorious students benefit from Vedanta's Utkarsh Scholarship awarded in presence of Goa CM

Robot-Assisted Cancer Surgery Unit Launched in Apollo Proton Cancer Centre

IndiGo is the leader in COVID vaccine distribution in the country over the last three months

Peter England launches 'The Antiviral* Linen Project' with new brand campaign 'Easy On You'

Den Networks Ltd Q4FY21 consolidated PAT drops QoQ to Rs. 36.98 crore

Isgec Heavy Engineering, United Conveyor Corporation sign agreement

Mindtree Ltd posts consolidated of Rs. 317.3 crore in Q4FY21

Government of Ghana to takeover ownership of AirtelTigo Joint Venture

ICRA retains ratings of Nahar Industrial Enterprises Ltd

NTPC to issue Non-Convertible Bonds

CRISIL retains rating of NGL Fine-Chem Ltd

GTPL Hathway's Consolidated FY21 PAT at ₹ 1,885 million, up by 145%

DCB Bank Limited receives RBI nod for reappointment of Mr. Murali M. Natrajan as MD & CEO

Mindtree Ltd Board approves final dividend of Rs. 17.50

RITES consortium emerges L1 in Railway project in Bangladesh

Ashok Leyland Delivers Light Bullet Proof Vehicles to Indian Air Force in collaboration with Lockheed Martin

Maruti Suzuki India Ltd increases price of select models from April 16, 2021


Website Created & Maintained by : Chennai Scripts
West Mambalam, Chennai - 600 033,
Tamil Nadu, India

disclaimer copyright © 2005 - 2020