India's COVID-19 Vaccine Found Very Effective

Hyderabad -based Bharat Biotech announced today the safety and efficacy analysis data from Phase III clinical trials of the COVAXIN vaccine, developed in partnership with ICMR and NIV Pune, India.

Phase 3 clinical trial of COVAXIN was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd vaccine dose, conducted at 25 sites across India. The highlight results are as follows:

• Efficacy analysis demonstrates COVAXIN® to be 77.8% effective against symptomatic COVID19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group,
• Efficacy analysis demonstrates COVAXIN® to be 93.4% effective against severe symptomatic COVID-19,
• Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events,
• Efficacy data demonstrates 63.6% protection against asymptomatic COVID-19, and
• Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.

Dr. Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, commented, “I am delighted to note that COVAXIN®, developed by ICMR and BBIL, has demonstrated an overall efficacy of 77.8% in India’s largest COVID phase 3 clinical trial thus far."

"Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of the highest international standards. As a result, COVAXIN® will benefit the Indian citizens and immensely contribute to protecting the global community against the deadly SARS-CoV-2 virus. I am also pleased to see that COVAXIN® works well against all variant strains of the SARS-CoV-2 coronavirus."

Bharat Biotech has established COVAXIN® manufacturing at 4 facilities within India, further expansions are in process to reach an annualized capacity of 1 billion doses by the end of 2021. In addition, technology transfer activities are in progress to companies in the United States (Ocugen, Inc.) and other countries.

The company has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization Pre-qualifications.