Bharat Biotech’s Covaxin found 100% effective against ’severe Covid disease’ in Phase-3 interim analysis

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.

"Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from Research and Development from India. The efficacy data against severe covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively," Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said.

The protocols for manufacturing, testing and release of inactivated vaccines have been tried, tested and validated across several of our vaccines; these also meet the requirements of WHO, Indian and other regulatory authorities. These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record, the company statement read.

India exported million of doses of Covaxin to other nations

Several million doses of Covaxin have been supplied and administered in India and many other countries with an excellent safety record, evident by the minimal or lack of adverse events post-immunization. Covaxin was approved and introduced initially through Emergency Use Authorization under the clinical trial mode, resulting in robust safety data in real-life conditions.

The company's efforts to further develop Covaxin continues, with clinical trials planned in India and globally to evaluate its safety and immunogenicity in younger age groups, the impact of booster doses, and protection against SARS-CoV-2 variants, Bharat Biotech said today.

Over 60 nations 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 across the whole SARS-CoV-2 virus. Emergency Use Authorizations have been received from several countries.