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Bharat Biotech says its COVID-19 vaccine is 77.8% effective overall

US development partner Ocugen is already planning to submit a BLA for the vaccine to the FDA

Along with its US development partner Ocugen, India’s Bharat Biotech has announced that their COVID-19 vaccine candidate COVAXIN offers 77.8% protection overall against the virus.

Bharat’s phase 3 vaccine study enrolled a total of 25,798 participants across 25 sites in India, including 2,750 people over the age of 60 and 7,065 with co-morbidities.

The efficacy analysis is based on 135 positive COVID-19 cases, with 24 observed in the vaccine group and 106 occurring in the placebo group.

Throughout the study, 16 severe COVID-19 cases were reported – one in the vaccine group and 15 in the placebo group, reflecting 93.4% efficacy against severe disease.

The phase 3 results showed that COVAXIN-vaccinated individuals achieved greater protection against the Delta (B.1.617.2) and Beta (B.1.351) variants compared to those with previous natural infections. Overall, the vaccine demonstrated 65.2% efficacy against the Delta variant, which was first identified in India.

On the safety front, 12.4% of participants experienced ‘commonly known’ side effects, with less than 0.5% experiencing serious adverse events.

In a statement, Ocugen added that both the adverse events and severe adverse events reported in the vaccine group occurred at a similar rate in the placebo group.

“The safety and efficacy readouts from phase 3 clinical trials present a comprehensive data package for COVAXIN. This has been a great journey of science leading to translational product development to combat this deadly pandemic,” said Krishna Ella, chairman and managing director, Bharat Biotech.

“We continue our efforts towards additional studies on variants of concern. Our commitment to data transparency has been sustained with ten publications within the past year, and we will share our findings with regulators worldwide,” he added.

Ocugen has already announced that it is planning to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for COVAXIN.

The US-based biopharma company announced that it has also initiated discussions with Health Canada for the potential regulatory approval of its COVID-19 vaccine.

Reuters reported that Bharat Biotech is planning to manufacture approximately 23 million doses of the whole virion inactivated COVID-19 vaccine candidate per month.

Article by
Lucy Parsons

5th July 2021

From: Research

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