Bharat Biotech Announces Phase 3 Results of COVAXIN®

Bharat Biotech Announces Phase 3 Results of COVAXIN®:
India’s First COVID-19 Vaccine Demonstrates Interim Clinical
Efficacy of 81%
 Data from 25,800 participants, received vaccine or placebo in a 1:1 ratio showed that
the vaccine candidate was well tolerated.
 COVAXIN® demonstrated 81% interim efficacy in preventing COVID-19 in those without
prior infection after the second dose.
 Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary
study endpoints.

Hyderabad, India, 03, March, 2021: 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

City Today News
9341997936

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