The phase-3 clinical trials results of indigenously developed Covid-19 vaccine Covaxin by Bharat Biotech International (BBIL) and Indian Council of Medical Research (ICMR) have demonstrated 100% efficacy against severe Covid-19 disease, said the two entities in a joint statement

Hyderabad-based vaccine manufacturing firm Bharat Biotech on Wednesday announced the interim efficacy data for the phase 3 trials of Covaxin, the first made-in-India coronavirus vaccine.

In the trial results, Bharat Biotech and the ICMR said that Covaxin demonstrates an overall interim clinical efficacy of 78%. The efficacy against severe Covid-19 disease was 100%, the company said.

The second interim analysis is based on accruing more than 87 symptomatic cases of Covid-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% against mild, moderate, and severe Covid-19 disease, the company said.

The efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalisations. The efficacy against asymptomatic Covid-19 infection was 70%, suggesting decreased transmission in Covaxin recipients, it added

The efficacy against asymptomatic Covid-19 infection was 70% suggesting decreased transmission in Covaxin recipients.

Safety and efficacy results in June

Safety and efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication. Bharat Biotech and the Indian Council of Medical Research (ICMR) have co-developed Covaxin, which is one of the two Covid-19 vaccines, currently approved for use in India by the national drugs regulator.

The efficacy was slightly lower than the first interim data that indicated the efficacy of 81% at a four-week interval between two doses.

The Phase 3 study enrolled 25,800 participants between 18 to 98 years of age, including 10% over the age of 60, with analysis conducted 14 days post-second dose.

 

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