'Covaxin Found To Be 77.8% Effective In Final Analysis Of Phase III Trials', Claims Bharat Biotech

Covaxin has been found to be 77.8 per cent effective against symptomatic Covid-19.

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Hyderabad: Bharat Biotech, the biotechnology firm on Saturday announced the efficacy and safety of the indigenous vaccine Covaxin which was jointly developed with the ICMR & NIV Pune. The firm said that it has concluded the final analysis of the Phase III trials. 

"Phase 3 clinical trials of Covaxin was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India," the official press release said. 

Key findings of the analysis:

• 77.8% effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.
• 93.4% effective against severe symptomatic Covid-19.
• 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events.
• Covaxin demonstrated 63.6% protection against asymptomatic Covid-19.
• Efficacy data showed 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.

According to Bharat Biotech, Covaxin is the first licensed Covid-19 vaccine to report promising efficacy against asymptomatic infections based on qPCR testing. This will help in reducing disease transmission, the company said.

In response to the fresh efficacy data, Director General of the Indian Council of Medical Research Dr Balram Bhargava said that Covaxin will "immensely contribute to protect the global community against the deadly SARS-CoV-2 virus" apart from benefiting Indian citizens.

“I am delighted to note that Covaxin, developed by ICMR and Bharat Biotech under an effective public-private partnership, has demonstrated an overall efficacy of 77.8 per cent 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. The successful development of Covaxin has consolidated the position of Indian academia and industry in the global arena," Dr Bhargava said.

The press release also stated that it has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.